Allied Health - Biofeedback

IMPORTANT REMINDER

Regence Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence.

PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services.

DESCRIPTION ^[1-5]

Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. The technique involves the feedback of a variety of types of information not normally available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiological process in some specific way. Biofeedback training is done either in individual or group sessions, alone, or in combination with other behavioral therapies designed to teach relaxation. A typical program consists of 10 to 20 training sessions of 30 minutes each. Training sessions are performed in a quiet, non-arousing environment. Subjects are instructed to use mental techniques to affect the physiologic variable monitored, and feedback is provided for successful alteration of that physiologic parameter. The feedback may be in the form of lights or tone, verbal praise, or other auditory or visual stimuli.

A variety of biofeedback devices are cleared for marketing though the Food and Drug Administration’s (FDA) 510(k) process. These devices are designated by the FDA as class II with special controls, and are exempt from the premarket notification requirements. The FDA defines a biofeedback device as “an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters”.

POLICY/CRITERIA

1. Biofeedback as part of the overall treatment plan for migraine or tension headaches may be medically necessary.
2. Unsupervised biofeedback in the home setting is considered investigational.
3. Biofeedback is considered investigational for all other indications, including but not limited to the following: 

Abdominal pain, recurrent

Anxiety disorders

Arthritis

Asthma

Autism

Back pain

Bell's palsy

Bruxism and sleep bruxism

Cardiovascular disorders

Chronic fatigue

Chronic pain

Chronic obstructive pulmonary disease (COPD)

Depression

Epilepsy

Facial palsy

Fecal incontinence, encopresis, and constipation (all types) in adults and children

Fibromyalgia

Hand hemiplegia

Headaches other than migraine and tension (e.g., cluster headaches)

Hypertension

Insomnia

Knee pain

Low back pain

Low vision

Lupus [systemic lupus erythematosus (SLE)]

Motor function after stroke, injury, or lower limb surgery

Movement disorders

Myalgia or muscle pain

Neck pain

Orthostatic hypotension in patients with a spinal cord injury

Post-traumatic stress disorder (PTSD)

Raynaud’s disease

Side effects of cancer chemotherapy

Temporomandibular joint disorders

Tinnitus

Urinary disorders

• Post-prostatectomy urinary dysfunction
• Urinary incontinence in adults
• Urinary retention
• Vesicoureteral reflux
• Voiding dysfunction

Vestibulodynia, vulvodynia, vulvar vestibulitis

SCIENTIFIC EVIDENCE

Background

Behavioral, i.e., non-drug, treatments including biofeedback result in both nonspecific and specific therapeutic effects. Nonspecific effects, sometimes called placebo effects, occur as a result of therapist contact, positive expectancies on the part of the patient and therapist, and other beneficial effects that occur as a result of being a patient in a therapeutic environment. Specific effects are those that occur only because of the active treatment, above any nonspecific effects that may be present.

In order to isolate the independent contribution of biofeedback on health outcomes (specific effects) and properly control for nonspecific treatment effects, well-designed clinical trials with the following attributes are necessary:

• Randomization
  Randomization helps to achieve equal distribution of individual differences by randomly assigning patients to either biofeedback or sham-biofeedback treatment groups. This promotes the equal distribution of patient characteristics across the two study groups. Consequently, any observed differences in the outcome may, with reasonable assuredness, be attributed to the treatment under investigation.
• Sham control group
  A comparable sham control group helps control for expected high placebo effects as well as for the variable natural history of the condition being treated.
• Blinding
  Blinding of study participants, caregivers, and investigators to active or sham assignments helps control for bias for or against the treatment. Blinding assures that placebo effects do not get interpreted as true treatment effects.
• Large study population
  Small studies limit the ability to rule out chance as an explanation of study findings.
• Adequate follow-up
  Follow-up periods must be long enough to determine the durability of any treatment effects.

The focus of the evidence review for biofeedback for all indications is on randomized controlled trials with the attributes noted above.

Evidence Review

Systematic Review

A 1995 BlueCross BlueShield Association Technology Evaluation Center (TEC) Assessment evaluated the use of biofeedback in the treatment of nine different conditions: anxiety disorders, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud’s disease, and insomnia.^[6] The Assessment reported the following conclusions:

• While a substantial number of studies reported improvement in the biofeedback group relative to the no-treatment group, there were generally no differences when the isolated effect of biofeedback was compared with relaxation or behavioral therapy alone.

• While there was evidence that feedback on physiological processes provided patients with an enhanced ability to control these processes, there was, nevertheless, no consistent evidence of any relationship between a patient’s ability to exert control over the targeted physiological process and any health benefits of the intervention. These findings underscore the importance of seeking controlled studies showing whether use of biofeedback improves disease-related health outcomes, as opposed to physiological, intermediate outcomes.

• Studies failed to consistently address the durability of effects beyond the initial, short-term biofeedback training period.

• The literature suggested that the outcomes of biofeedback relative to no treatment were due to the other components of therapy or to the nonspecific effects of the therapeutic setting, not a result of the biofeedback training, per se.

Anxiety disorders                                                                   Back to Criteria

The current published clinical trial data is insufficient to allow scientific conclusions concerning the contribution of biofeedback to improvements in health outcomes in the treatment of anxiety disorders.

The 1995 TEC Assessment concluded that evidence was insufficient to demonstrate the effectiveness of biofeedback for treatment of anxiety disorders. ^[6]

Since the 1995 TEC Assessment, no well-designed randomized, controlled clinical trial data has been published.

Asthma                                                                                    Back to Criteria

Lehrer and colleagues^[7] reported the results of a trial of 94 asthma patients randomized to one of the following four groups:

1. “Full protocol” including heart rate variability (HRV) biofeedback and training in pursed-lips abdominal breathing with prolonged exhalation
2. HRV biofeedback alone
3. Placebo biofeedback involving bogus “subliminal suggestions designed to help asthma”, with no other details provided and no actual suggestions given plus biofeedback training to alternately increase and decrease frontal EEG alpha rhythms
4. A waiting list control group

Although reported improvement was greater in the two treatment groups, scientific conclusions cannot be drawn from this data due to several limitations, as discussed in the Background section above, including possible selection bias due to lack of randomization, short study duration, lack of follow-up to assess long-term effects, and differences between groups in task involvement and assessment frequency. The authors concluded that further research is needed.  They advise caution in the use biofeedback for the treatment of asthma until the mechanisms of action are better understood and the long-term effects have been documented.

Autism                                                                                         Back to Criteria

The scientific evidence on the effectiveness of biofeedback for treatment of autism consists of a limited number of small, non-randomized studies. Each individual autism patient is highly different from the next and those differences – clinical and demographic, known and unknown – may impact the treatment outcome in ways that cannot be quantified without a systematic study that controls for bias as discussed in the Background section above.

A 2010 article by Coben and Myers reviewed the literature on EEG biofeedback for autistic disorders.^[8] The authors identified 2 published small, non-randomized controlled studies evaluating EEG biofeedback in the treatment of autistic disorders. As described in the review, a study published by Jarusiewicz and colleagues in 2002 compared treatment with 20 to 69 sessions of biofeedback in 12 autistic children to a matched control group that did not receive biofeedback. Mean reduction in autistic symptoms, as measured by the Autism Treatment Evaluation Checklist (ATEC), was 26% in the biofeedback group and 3% in the comparison group; this difference was statistically significant. The other study was published by Coben and Padolsky in 2007. It compared 20 sessions of EEG biofeedback in 37 patients to a waiting-list control group. After treatment, parents reported reduction in symptoms in 89% of the treatment group compared to 17% of the control group (p-value not reported). Studies differed in their biofeedback protocols and number of sessions. The review article concluded that randomized controlled trials (RCTs) are needed to determine the effectiveness of biofeedback to treat autism.

Bell's palsy                                                                                Back to Criteria

Cardoso et al. examined the effects of facial exercises associated either with mirror or EMG biofeedback with respect to complications of delayed recovery in Bell's palsy.^[9] Patients with unilateral idiopathic facial palsy treated with facial exercises associated with mirror and/or EMG biofeedback were included in this review. Four studies (n=132) met the eligibility criteria. The studies described mime therapy versus control (n=50), mirror biofeedback exercise versus control (n=27), "small" mirror movements versus conventional neuromuscular retraining (n=10), and EMG biofeedback plus mirror training versus mirror training alone. The treatment length varied from 1 to 12 months. The authors concluded that “…because of the small number of randomized controlled trials, it was not possible to analyze if the exercises, associated either with mirror or EMG biofeedback, were effective. In summary, the available evidence from randomized controlled trials is not yet strong enough to become integrated into clinical practice.”

Bruxism and sleep bruxism                                                    Back to Criteria

One small randomized study (n=57) examined changes in sleep bruxism following treatment with a cognitive behavioral therapy program consisting of problem-solving, progressive muscle relaxation, nocturnal biofeedback, and training of recreation and enjoyment.^[10] Similar improvements were observed for the occlusal splint group as for the multicomponent cognitive behavioral program. The effects of biofeedback were not isolated in this study and thus conclusions cannot be drawn about its effectiveness compared to occlusal splinting.

Chronic Pain                                                                              Back to Criteria

As discussed in the Background section above, the focus of the evidence review was on randomized controlled trials. This study design is particularly important when studying treatments for pain due to the expected high placebo effect. The current published clinical trial data is insufficient to allow scientific conclusions concerning the contribution of biofeedback to improvements in health outcomes in the treatment of chronic pain.

The 1995 TEC Assessment concluded that evidence was insufficient to demonstrate the effectiveness of biofeedback for treatment of chronic pain.^[6] In 1996, the National Institutes of Health (NIH) convened a technology assessment panel, entitled “Integration of Behavioral and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia.”^[11] The panel reviewed a variety of behavioral interventions in addition to biofeedback including relaxation, hypnosis, and cognitive-behavioral therapy. For biofeedback, the panel concluded that the evidence is moderate for the effectiveness of biofeedback in treating a variety of types of pain. The statement did not discuss in depth the independent contribution of the feedback component beyond that of relaxation alone. In the summary conclusion on treating chronic pain, the assessment stated that “Although relatively good evidence exists for the efficacy of several behavioral and relaxation interventions in the treatment of chronic pain, the data are insufficient to conclude that one technique is usually more effective than another for a given condition.”

A Cochrane review by Eccleston and colleagues on psychological therapies (cognitive-behavioral therapy [CBT] and behavioral therapy, including biofeedback) for chronic pain in adults was updated in 2009.^[12] Two randomized, controlled trials (RCTs) were reviewed that compared behavioral therapy against an active control designed to change behavior (e.g., exercise or instruction). Three RCTs had sufficient follow-up to be included in a comparison of behavioral therapy against usual treatment. The systematic review found that although the quality of trial design had improved over time, there were too few studies to achieve a meaningful conclusion about the effects of behavioral therapy on pain, disability, or mood. Another Cochrane review by Eccleston and colleagues evaluated psychological therapies for the management of chronic and recurrent pain in children and adolescents.^[13] Although psychological therapies were found to improve pain, only 1 of the 5 studies on non-headache pain evaluated biofeedback.

Arthritis                                                                                      Back to Criteria

In a meta-analysis of psychological interventions for rheumatoid arthritis including relaxation, biofeedback, and cognitive-behavioral therapy, Astin and colleagues concluded that psychological interventions may be important adjunctive therapies in rheumatoid arthritis treatment. ^[14] In the 25 studies analyzed, significant pooled effect sizes were found for pain after an intervention. However, the same effect was not seen long term, and the meta-analysis did not isolate biofeedback from other psychological interventions. Therefore, the specific effects of biofeedback, as discussed in the Background section above, could not be isolated.

Knee pain                                                                                   Back to Criteria

Dursun and colleagues and Yilmaz and colleagues randomized 60 and 40 patients with knee pain, respectively, to EMG biofeedback plus conventional exercise or conventional exercise alone. ^[15,16] There were no differences between groups on pain or function.

Low Back Pain                                                                           Back to Criteria

A 2010 Cochrane review on behavioral treatments for chronic low-back pain included a meta-analysis of 3 small randomized trials comparing electromyography (EMG) biofeedback to a waiting-list control group.^[17] In the pooled analysis there were a total of 34 patients in the intervention group and 30 patients in the control group. The standard mean difference in short-term pain was -0.80 (95% confidence interval [CI]:-1.32 to -0.28); this difference was statistically significant favoring the biofeedback group. The Cochrane review did not conduct meta-analyses of trials comparing biofeedback to sham biofeedback and therefore did not control for any non-specific effects of treatment.

Two randomized trials have compared biofeedback to a sham intervention for treatment of lower back pain; neither found a statistically significantly benefit with real biofeedback. Bush and colleagues who randomized 62 patients to receive either EMG biofeedback, sham biofeedback, or a no treatment control.^[18] At the conclusion of the trial, all three groups showed significant improvement in multiple measures of pain. There were no significant effects found for treatment type, leading the authors to conclude that biofeedback is not superior to placebo in controlling chronic pain. In 2010, Kapitza and colleagues compared the efficacy of respiratory biofeedback to sham biofeedback in 42 patients with lower back pain.^[19] All participants were instructed to perform daily breathing exercises with a portable respiratory feedback machine; exercises were performed for 30 minutes on 15 consecutive days. Patients were randomized to an intervention group that received visual and auditory feedback of their breathing exercises or a control group that received a proxy signal imitating breathing biofeedback. Patients recorded pain levels in a diary 3 times a day, measuring pain on a visual analogue scale (VAS). Both groups showed reduction in pain levels at the end of the intervention period and at the 3 month follow-up, but there were no significant differences in pain between groups. For example, the mean change in pain with activity 3 months after the intervention was a reduction in 1.12 points on a 10-point VAS scale in the intervention group and 0.96 points in the sham control group; p>0.05. The mean change in pain at rest after 3 months was a reduction of 0.79 points in the intervention group and 0.49 points in the control group; p>0.05.

Another randomized trial, by Glombiewski and colleagues, assessed whether the addition of EMG biofeedback to CBT improved outcomes in 128 patients with lower back pain.^[20] Patients with musculoskeletal pain of the low, mid, or upper back, with pain duration of at least 6 months on most days of the week, were randomized to CBT, CBT plus biofeedback, or a waiting-list control; 116 patients began the 1-hour weekly sessions (17-25 treatments) and were included in the final analysis. CBT alone included breathing exercises and progressive muscle relaxation; biofeedback was used for 40% of the CBT treatment time in the combined treatment condition. Both treatments were found to improve outcomes including pain intensity compared to a waiting-list control (moderate effect size of 0.66 for pain intensity in the CBT plus biofeedback group). However, the addition of biofeedback did not improve outcomes over CBT alone.

Lupus                                                                                          Back to Criteria

In a randomized controlled trial of 92 patients with systemic lupus erythematosus (SLE), Greco and colleagues reported that  patients treated with six sessions of biofeedback-assisted cognitive-behavioral treatment for stress reduction had a statistically significant greater improvement in pain post treatment than a symptom-monitoring support group (p=0.044) and a usual care group (p=0.028).^[21] However, these improvements in pain were not sustained at nine month follow-up and further studies are needed to determine the incremental benefits of biofeedback-assisted cognitive-behavioral treatment over other interventions in SLE patients.

Recurrent abdominal pain                                                          Back to Criteria

Humphrey’s and Everts randomly assigned 64 patients with recurrent abdominal pain to groups treated with: 1) increased dietary fiber; 2) fiber and biofeedback; 3) fiber, biofeedback, and cognitive-behavioral therapy; and 4) fiber, biofeedback, cognitive-behavioral therapy, and parental support. ^[22] The three multi-component treatment groups were similar and had better pain reduction than the fiber-only group. This study does not address placebo effects. In a systematic review of recurrent abdominal pain therapies in children, Weider and colleagues concluded that behavioral interventions (cognitive-behavioral therapy and biofeedback) had a general positive effect on nonspecific recurrent abdominal pain and were safe. ^[23] However, the specific effects of biofeedback were not isolated in this systematic review.

Vulvar vestibulitis                                                                       Back to Criteria

A randomized study by Bergeron of 78 patients with vulvar vestibulitis compared biofeedback, surgery and cognitive-behavioral therapy. ^[24] Surgery patients had significantly better pain scores than patients who received biofeedback or cognitive-behavioral therapy. No placebo treatment was used.

Other chronic pain                                                                      Back to Criteria

Other pain for which there are no clinical trial publications sufficient to demonstrate the effectiveness of biofeedback include muscle pain or myalgia and neck pain.

Fecal Incontinence and constipation with or without encopresis
                                                                                                   Back to Criteria

The relevant clinical outcome in studies of biofeedback as a treatment of fecal incontinence, encopresis, and constipation should be the overall change in the bowel symptoms. Changes in anorectal physiological assessment (e.g., anal pressure, sensory threshold) often do not correlate with symptom relief (i.e., clinical outcomes. Reduction in episodes of fecal incontinence, encopresis, and constipation, and increase in voluntary bowel movements are the primary clinical outcome. Patient symptoms are usually assessed through diary, questionnaire or interview.

Current evidence is insufficient to assess the effects of biofeedback for the management of organic fecal incontinence.

• There is no reliable, long-term evidence from well-designed, well-executed, placebo-controlled, prospective, randomized controlled trials on the effectiveness of biofeedback as a treatment of fecal incontinence in adults and children. Current studies consist of unreliable case series, observational studies and systematic review.
• Due to numerous methodological flaws, the few available randomized controlled trials (RCTs) are insufficient to permit conclusions on the effect of biofeedback on fecal incontinence. These study design flaws include inadequate or lack of randomization or blinding, lack of appropriate control groups for comparison, small sample size, short follow-up period, nonspecific treatment effects, and lack of validated outcome measures.
• Between-study comparisons are difficult for the following reasons:
  
  
  1. Lack of uniform criteria for patient inclusion.
     
     
     • Some studies included only chronic constipation patients, some only encopresis, and some constipation with encopresis.
     • Studies often failed to specify the characteristics of the population and the subgroups with different symptoms and diseases.  Patients with weak pelvic floor muscles and normal rectal sensation may only need strength training, while patients with normal pelvic floor muscle strength and poor rectal sensation may only need sensory or coordination training.
     • Most studies did not identify and report the cause of incontinence and did not conduct analysis on patient subgroups.
       
       
  2. Lack of standardized criteria for assessing outcome.
     
     
     • Studies reported cure rates and improvement rates, but the outcomes and methods underlying their measurement varied across studies.
     • The criterion for success ranged widely from 25% to 90% reduction in episodes across studies.
       
       
  3. Diversity among treatment protocols. For example, in their review of 34 studies, Norton and Kam noted that many different treatment modalities have been described by the term "biofeedback." They stated, "No two studies have described exactly the same treatment as ‘biofeedback’." ^[25]

In summary, stronger research with more rigorous quality, as discussed in the Background section above,  is needed to allow a reliable assessment of biofeedback therapy in the management of adults with fecal incontinence. This includes sham-placebo, randomized controlled trials that:

1. Have replicable standardized interventions
2. Control for confounding factors and bias
3. Provide valid short and long-term outcome measures and adequate power

Fecal incontinence in adults                                                       Back to Criteria

Case series and observational studies of biofeedback in the treatment of fecal incontinence have reported a wide range of improvement rates from 50% to 92%. 

Several systematic reviews of biofeedback treatment for fecal incontinence in adults have been published, including two Cochrane Reviews.^[25-31] The majority of the studies identified in these reviews were uncontrolled and the authors noted the need for larger well-designed trials. Only two of the RCTs included in these reviews were of sufficient size (171 and 120 patients, respectively).^[32,33] No greater benefit was found for biofeedback compared with standard care.

The conclusions from these systematic reviews of the randomized, comparative studies are as follows:

• There is insufficient evidence from controlled trials to evaluate whether biofeedback treatments are helpful
  
• There is insufficient evidence to determine which aspects of biofeedback are the most helpful and which patients are the most likely to be helped by biofeedback
  
• The evidence for biofeedback based on observational studies and methodologically weak controlled trials can be viewed only as tentative

One randomized trial has been reported since the above systematic reviews were published.^[34] Of the original 168 patients randomized to either pelvic floor exercise training alone or exercise training with manometric biofeedback, only 108 (64%) went on to receive intervention; therefore, it is unknown whether the randomization scheme was maintained or whether the treated groups had baseline differences that may have effected outcomes.  

Two of three clinical practice guidelines consider biofeedback no more effective than standard care in treatment of fecal incontinence in adults.

• The National Institutes of Health released a conference statement stating that, “Pelvic floor muscle training and biofeedback are effective in preventing and reversing some pregnancy-related fecal and urinary incontinence for the first year after delivery. There is insufficient research on the sustained long-term benefits of pelvic floor muscle training or biofeedback on preventing fecal or urinary incontinence.”^[35]
• Similarly, the National Institute for Health and Clinical Excellence (NICE) guidance on treatment of fecal incontinence in adults states that “The evidence we found did not show biofeedback to be more effective than standard care, exercises alone, or other conservative therapies. The limited number of studies and the small number of participants in each group of the studies make it difficult to come to any definitive conclusion about its effectiveness”.^[36]
• In contrast, based on the same evidence, an American Society of Colon and Rectal Surgeons practice parameter recommended biofeedback “as an initial treatment for motivated patients with incontinence with some voluntary sphincter contraction.^[37] Biofeedback may be considered a first-line option for many patients with fecal incontinence who have not responded to simple dietary modification or medication. Supportive counseling and practical advice regarding diet and skin care can improve the success of biofeedback. Biofeedback may be considered before attempting sphincter repair or for those who have persistent or recurrent symptoms after sphincter repair. It may have a role in the early postpartum period in females with symptomatic sphincter weakness. Biofeedback and a pelvic floor exercise program can produce improvement that lasts more than two years. Biofeedback home training is an alternative to ambulatory training programs, especially in the elderly.”

Fecal incontinence in children                                                    Back to Criteria

Four systematic reviews of biofeedback treatment for fecal incontinence in children have been recently published, including two Cochrane reviews. In two separate systematic reviews^[38,39] of a total of nine randomized trials^[40-48] Coulter and colleagues and Brazelli and Griffiths reported that most studies showed that the control group had greater benefit from intervention than the biofeedback training group.^[28,39] Specifically, seven of these studies reported higher, rather than lower, rates of persistent encopresis when biofeedback was added to conventional treatment. Only one study reported significant results in favor of biofeedback.^[45] However, the long-term follow-up of this study showed that biofeedback training did not improve recovery rate over conventional treatment in children with abnormal defecation dynamics.^[46] A 2006 updated literature review confirmed the initial results. ^[38] Combined results of nine trials showed higher rather than lower rates of persisting symptoms of fecal incontinence up to 12 months when biofeedback was added to conventional treatment. The authors concluded that there is no evidence that biofeedback training added any benefit to conventional treatment in the management of functional fecal incontinence in children.

Since these meta-analyses, one additional randomized trial was published in which the authors reported that the results at 6-months follow-up did not differ between biofeedback and customary care.^[49]

The conclusion from the above four systematic reviews of the randomized, comparative studies is similar to that reached for adults:

• There is insufficient evidence from controlled trials to evaluate whether biofeedback treatments are helpful
  
• The evidence for biofeedback based on observational studies and methodologically weak controlled trials can be viewed only as tentative

Constipation in adults                                                               Back to Criteria

Studies are limited to poorly designed randomized trials and case series.  For example, Heymen et al. randomized 84 patients with intractable dyssynergia-type constipation to one of three groups who received diazepam, placebo medication, or biofeedback.^[50] All groups were also trained in pelvic floor exercises. At 3 months follow-up, the biofeedback group reported significantly higher relief of constipation symptoms than the other two groups (70% compared to 23% in the diazepam group and 38% in the placebo medication group). This outcome is unreliable since there was no sham biofeedback group and patients were not blinded to biofeedback treatment, and because of the short follow-up period. Rao et al. randomized 77 patients to standard therapy i.e., education, dietary advice alone, standard therapy with biofeedback or standard therapy with sham biofeedback.^[51] The biofeedback group achieved significantly greater correction of dyssynergia patterns than the other two groups.  However, patients were not blinded to their treatment group, so the purpose of the sham group is invalidated. In a follow-up of this study, one-year findings were reported.^[52] Patients in the sham group were not included in the follow-up study. In addition to the flaws in the initial study, there was a large loss to follow-up in this study, with only 7 of the original 28 patients in the biofeedback group, and 13 of the original 24 patients in the standard treatment group completing the one-year follow-up period. These unreliable studies do not permit conclusions on the effect of biofeedback on constipation in adults.

The American Gastroenterological Association (AGA) guidelines notes that, “formal evaluations of biofeedback training in constipation are sparse, and important practical details of individual programs are often not stated.”^[53,54] In spite of this statement, the AGA guidelines consider biofeedback a possible treatment for patients with severe symptoms and proven pelvic floor dysfunction.

The American Society of Colon and Rectal Surgeons practice parameters recommend biofeedback in patients with symptomatic pelvic floor dyssynergia [Evidence level Class II, Grade B, defined as at least one well-designed experimental study with high false-positive or high false-negative errors or both (low power), and generally consistent findings.]^[55] 

Constipation in children                                                            Back to Criteria

One randomized controlled trial was found for biofeedback in the treatment of constipation in children.^[56] Groups included standard treatment i.e., education, laxatives (n=111) or standard treatment plus two sessions of anorectal manometry (n=91). Manometry measurements were viewed by the child and parent during measurement sessions and the data discussed after each session with instructions in home exercises. At 6 weeks follow-up, there was no significant different in success between the standard treatment group (4%) and the biofeedback group (7%). At the final 104 week follow-up, 43% of the standard treatment group and 35% of the biofeedback group were considered treatment successes. This difference was not significant. The authors noted that 30% of the randomized patients were missing at the final follow-up.

A practice guideline from the National Institute for Clinical Excellence (NICE) on constipation in children and young people states that biofeedback should not be used for ongoing treatment of idiopathic constipation.^[57] Similarly, the American Gastroenterological Association (AGA) guidelines notes that results of biofeedback in children have been “disappointing.”^[53,54] The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHN) considers biofeedback to be effective in short-term treatment in selected children with intractable constipation, but does not consider it to be a long-term solution.^[58]

Fibromyalgia                                                                              Back to Criteria

Fibromyalgia treatment was studied by Buckelew and colleagues using four treatment groups; however, neither the placebo effect nor the impact of adding biofeedback to relaxation therapy was studied (see the Background section above).^[59] In a randomized clinical trial of 143 females with fibromyalgia, van Santen and colleagues compared biofeedback and fitness training to usual care.^[60] The primary outcome evaluated was pain using a visual analogue scale. The authors reported there were no clear improvements in objective or subjective patient outcomes with biofeedback (or fitness training) over usual care.

Headache                                                                                   Back to Criteria

The evidence is insufficient to determine the effect of biofeedback for the prevention or treatment of headaches other than migraine and tension headaches, including but not limited to cluster headaches.

Tension and Migraine Headache

Despite the poor quality of case series and randomized controlled trials, biofeedback has evolved into a standard of care as part of comprehensive regimens, including medication and relaxation techniques, for treatment and prevention of tension-type headaches, and the prevention of migraine headaches.

• Data from case series and randomized controlled trials is difficult to interpret due to poor study design, high drop-out rates, and inconsistent outcomes.^[61-66]
• A number of systematic reviews have reported small beneficial effects in children and medium to large beneficial effects in adults when biofeedback is used in conjunction with other prevention measures such as relaxation techniques.^{[12,13,67-72]}
• Clinical practice guidelines from professional associations include biofeedback in their recommendations for prevention of tension and migraine headaches.^[73-77]
• Clinical input recommended biofeedback as a reliable nonpharmacologic option for headache treatment and prevention.

Cluster Headache

Due to the lack of clinical trial data, the evidence is insufficient to determine the efficacy of biofeedback in the management of cluster headaches.

• No clinical trial reports were found that focus on the efficacy of biofeedback alone or as part of a comprehensive treatment program.
• Few clinical practice guidelines or position statements from professional associations mention cluster headache, and none recommended biofeedback for management of cluster headache.

Hypertension                                                                             Back to Criteria

Randomized controlled trials are currently limited to small, short-term studies that do not permit scientific conclusions (see the Background section above).

Two studies used the same sample of patients with mild, unmedicated essential hypertension. ^[78,79] Investigators randomized 30 patients to either active or true biofeedback or feedback in which systematic changes in blood pressure were partially disguised. The earlier study used a shorter overall training period and failed to show differences between groups. In contrast, the later study performed laboratory training plus four weeks of home training; the active group lowered blood pressure to a greater extent than placebo group patients at the end of training. The results of the second study suggested nonspecific effects for biofeedback; however, it is unclear whether the partial disguising of treatments achieved effective double-blinding. One additional trial randomized 38 patients to either active or sham biofeedback.  At twelve weeks followup, the active group lowered blood pressure significantly more than the sham group.  None of these studies address intermediate or long-term results.

In a 2010 systematic review, Greenhalgh and colleagues concluded, “…we found no convincing evidence that consistently demonstrates the effectiveness of the use of any particular biofeedback treatment in the control of essential hypertension when compared with pharmacotherapy, placebo, no intervention or other behavioral therapies.”^[80] Trials generally had small sample sizes; only 4 included more than 100 patients. Trials included a variety of biofeedback techniques, and some included more than one modality.  Results were not pooled due to differences in interventions and outcomes and the generally poor quality of the studies.  Only 1 trial was identified that compared a biofeedback combination intervention to sham biofeedback, and this study did not find a significant difference in the efficacy of the 2 interventions. Only 4 studies on biofeedback alone and 4 on a combined biofeedback intervention reported data beyond 6 months; most of these found no significant differences in efficacy between the biofeedback and control groups. Rainforth and colleagues reviewed randomized, controlled trials and all previous meta-analyses related to stress reduction programs including biofeedback.^[81] Each type of therapy was analyzed separately.  No significant reduction in blood pressure was achieved using biofeedback alone or biofeedback combined with relaxation training.

Insomnia                                                                                   Back to Criteria

In 2006, an American Academy of Sleep Medicine Report update was released entitled Practice Parameters for the Psychological and Behavioral Treatment of Insomnia.^[82] In the section, Recommendations for Specific Therapies, item 3.9, the report states that “Biofeedback is effective and recommended therapy in the treatment of chronic insomnia. (Guideline)” The American Academy of Sleep Medicine (AASM) definition for guideline is “a patient-care strategy, which reflects a moderate degree of clinical certainty. The term guideline implies the use of Level II Evidence (randomized trials with high alpha and beta error or a consensus of Level III Evidence (non-randomized concurrently controlled studies).”

No other relevant guidelines or clinical trial data were identified.

Motor function after stroke, injury, or lower limb surgery      Back to Criteria

Several systematic reviews have been published; none of these conducted quantitative pooling of results due to heterogeneity among study populations, interventions, and outcome measures. A 2010 systematic review by Silkman and McKeon evaluated the effectiveness of electromyography (EMG) biofeedback for improving muscle function during knee rehabilitation after injury.^[83] Four RCTs that compared knee rehabilitation exercise programs with and without biofeedback were identified. Sample sizes in individual studies ranged from 26 to 60 patients. Two of the 4 studies found a statistically significantly greater benefit in the programs that included biofeedback, and the other 2 did not find a significant difference between groups. The positive studies assessed intermediate outcomes e.g., contraction values of the quadriceps muscles. None of the studies were designed to assess functional outcomes.

A Cochrane review that assessed EMG biofeedback for the recovery of motor function after stroke was published in 2007.^[84] It included 13 randomized or quasi-randomized studies with a total of 269 patients. All of the trials compared EMG biofeedback plus standard physiotherapy to standard physiotherapy; in addition to standard physiotherapy, several studies also included a sham biofeedback group. The studies tended to be small and poorly designed. The authors did not find support for EMG biofeedback to improve motor power, functional recovery, or gait quality when compared to physiotherapy alone.

A 2010 systematic review by Zijlstra and colleagues searched for studies evaluating biofeedback-based training to improve mobility and balance in adults older than 60 years of age.^[85] Although the review was not limited to studies on motor function after stroke, more than half of the studies included older adults post-stroke. For inclusion in this review, studies needed to include a control group of patients who did not receive biofeedback and to assess at least 1 objective outcome measure. A total of 97 potentially relevant articles were identified, and 21 (22%) studies, including 17 RCTs, met the selection criteria. Twelve of the 21 (57%) studies included individuals post-stroke; 3 included older adults who had lower-limb surgery and 6 included frail older adults without a specific medical condition. Individual studies were small with sample sizes that ranged from 5 to 30 patients. The added benefit of using biofeedback could be evaluated in 13 of 21 (62%) studies. Nine of the 13 studies found a significantly greater benefit with interventions that used biofeedback compared to control interventions. However, the outcomes assessed were generally not clinical outcomes but were laboratory-based measures related to executing a task, e.g., moving from sitting to standing in a laboratory setting and platform-based measures of postural sway. The applicability of improvements in these types of measures to clinical outcomes such as the ability to perform activities of daily living or the rate of falls is unknown. Only 1 study cited in this review reported an improvement in fall rates, and this trial could not isolate the effect of biofeedback from other components of treatment. In addition, only 3 studies reported long-term outcomes, and none of these reported a significant effect of biofeedback. Conclusions about the efficacy of biofeedback for improving mobility and balance in older adults cannot be drawn from these data due to the lack of evidence on clinical outcomes. Other methodologic limitations included limited data on the durability of effects and the inability to isolate the effect of biofeedback in many studies.

A 2010 RCT, not included in the Zijlstra et al. review, evaluated biofeedback to improve motor function in patients who were at least 6 months post-stroke.^[86] The study, conducted in Italy by Jonsdottir and colleagues, randomized 20 patients to 20 sessions of EMG biofeedback (n=10) or standard rehabilitation (n=10). Patients in both groups received sessions lasting 45 minutes 3 times a week. The biofeedback consisted of an acoustic signal; patients in the intervention group wore a biofeedback belt device. All patients completed the 20 sessions, and 9 in each group (a total of 90%) were available for the follow-up 6 weeks after completion of the intervention. The analyses found statistically significant effects of the biofeedback intervention on the outcome variables ankle power, peak velocity, and stride length but not knee flexion peak from baseline evaluation to the final follow-up. For example, in the treatment group, stride length (percent height per second) increased from 44.1 pre-treatment to 51.1 at final follow-up, and stride length in the control group increased from 33.4 pre-treatment to 35.2 at final follow-up. Although positive, data from this study alone cannot change the conclusion of an insufficient body of evidence on biofeedback to improve motor function after stroke. Moreover, the study did not evaluate outcomes related to activities of daily living, and the biofeedback protocol used in the study has not been replicated in other studies.

Movement Disorders                                                                Back to Criteria

Since the 1995 TEC assessment, randomized, controlled trials either failed to show any beneficial impact of biofeedback or had design flaws that leave the durability of effects in question or create uncertainty about the contribution of nonspecific factors such as attention or placebo effects.^[87-90] A Cochrane review assessing EMG biofeedback for the recovery of motor function after stroke included thirteen randomized or quasi-randomized studies.^[84] The authors did not find support for EMG biofeedback to improve motor power, functional recovery, or gait quality when compared to physiotherapy alone, although the results were limited due to small, poorly designed trials. Use of different assessment scales made pooling data for meta-analysis impossible.

Orthostatic hypotension in patients with a spinal cord injury  Back to Criteria

Gillis et al. conducted a systematic review to identify and describe the body of literature pertaining to nonpharmacologic management of orthostatic hypotension during the early rehabilitation of persons with a spinal cord injury.^[91] Participants with any level or degree of completeness of spinal cord injury and any time elapsed since their injuries were included. Interventions must have measured at least systolic blood pressure and have induced orthostatic stress in a controlled manner and have attempted to control orthostatic hypotension during an orthostatic challenge. Four distinct nonpharmacologic interventions for orthostatic hypotension were identified: application of compression and pressure to the abdominal region and/or legs, upper body exercise, functional electrical stimulation applied to the legs, and biofeedback. Methodologic quality varied dramatically between studies. The authors concluded that “…The clinical usefulness of compression/pressure, upper body exercise and biofeedback for treating OH [orthostatic hypotension] has not been proven.”

Raynaud’s Phenomenon                                                            Back to Criteria

The Raynaud’s Treatment Study Investigators conducted a randomized comparison of sustained-release nifedipine and thermal biofeedback in 313 patients with primary Raynaud’s phenomenon.^[92] In addition to these two treatment groups, there were two control treatments: pill placebo and EMG biofeedback. EMG biofeedback was chosen as a control because it did not address the physiological mechanism of Raynaud’s phenomenon. Nifedipine significantly reduced Raynaud’s attacks compared with placebo pill (p<0.001), but thermal biofeedback did not differ from EMG biofeedback (p=0.37). Better outcome for nifedipine relative to thermal biofeedback was nearly significant (p=0.08). With a larger sample size, the rate of 56% fewer attacks with nifedipine relative to thermal biofeedback would likely have been statistically significant. Thus, it cannot be concluded that thermal biofeedback is as effective as this form of medical therapy. A 2009 systematic review identified 5 trials that reported a variety of outcomes. A pooled analysis from 4 trials (total n=110) on the change in frequency of attacks favored the sham control group over the biofeedback group.^[93]

Temporomandibular Joint Disorders                                        Back to Criteria

In a systematic review of therapies for temporomandibular joint (TMJ) disorders including exercise, electrotherapy and biofeedback, Medlicott and colleagues recommended caution in interpreting results due to heterogeneity in study design and interventions used.^[94] Since biofeedback was not isolated from other therapies, no conclusions could be reached for biofeedback alone. McNeely and colleagues also conducted a systematic review.^[95] Based on two poor-quality randomized controlled trials, the authors concluded that biofeedback did not reduce pain more than relaxation or occlusal splint therapy for TMJ, but did improve oral opening when compared with occlusal splints.

Tinnitus                                                                                      Back to Criteria

Weise et al. investigated the efficacy of a biofeedback-based cognitive-behavioral treatment for tinnitus in Germany. Tinnitus patients (n=130) were randomly assigned to an intervention or a wait-list control group.^[96] Treatment consisted of 12 sessions of a biofeedback-based behavioral intervention over a 3-month period. The primary outcome measures were global tinnitus annoyance and a daily rating of tinnitus disturbance measured by a Tinnitus Questionnaire (TQ) and a daily diary using visual analog scale (VAS) scores. Patients in the wait-list group participated in the treatment after the intervention group had completed the treatment. Results showed improvements regarding the following: tinnitus annoyance; diary ratings of loudness; feelings of controllability; changes in coping cognitions; changes in depressive symptoms; TQ: total score (range 0–84) preassessment mean 54.7, postassessment mean 32.52; TQ: emotional distress (range 0–24) preassessment mean 16.00, postassessment mean 8.15; and diary: loudness VAS (range 0–10) preassessment mean 5.68, postassessment mean 4.38. Improvements were maintained over a 6-month follow-up period in which variable effect sizes were observed. The study does not investigate the possible additive effect of biofeedback with cognitive-behavioral therapy and did not include an active treatment control group. In conclusion, these data are insufficient to draw clinical conclusions regarding the role of biofeedback for the treatment of tinnitus.

Urinary Incontinence                                                                 Back to Criteria

A 1997 BlueCross BlueShield Association Technology Evaluation Center (TEC) Assessments focused on the independent contribution of biofeedback as an adjunct to pelvic floor muscular exercises for the treatment of urinary incontinence. The 1997 TEC Assessment concluded that while the controlled trials that isolated the contribution of biofeedback reported conflicting results, the weight of the evidence suggested no additional benefit for biofeedback above that obtained with pelvic floor muscle exercises alone.^[97] All of the trials had low power to detect a small difference in outcomes; therefore, the possibility exists that larger trials with improved statistical power could demonstrate a beneficial effect of biofeedback. However, the TEC Assessment concluded that based on the available data, any such benefit, if present, was likely to be small and may not be clinically significant.

The conclusions of a 2000 TEC Assessment^[98] were similar to the 1997 assessment, i.e., that the evidence was not sufficient to demonstrate an additional benefit for biofeedback above that obtained with pelvic floor muscle exercises (PME) alone:

1. Six controlled trials reported outcomes of biofeedback for the treatment of stress incontinence.
   
   These trials failed to demonstrate that the addition of biofeedback was superior to PME alone

2. One small, non-randomized study focused on patients with urge incontinence.
   
   There was no statistically significant improvement in outcomes for the biofeedback plus PME group as compared to the PME alone group.

3. One randomized trial investigated biofeedback in men with post-prostatectomy incontinence, a relatively uncommon indication for biofeedback at that time.^[99]
   
   A total of 30 patients were randomized to usual care or usual care plus biofeedback. Both groups improved significantly over time, but there was no difference between groups in the magnitude of improvement.

The focus of the both the 1997 and 2000 TEC Assessments contrasted with the 1996 assessment on treatment of incontinence published by the Agency for Healthcare Research and Quality (formerly the Agency for Health Care Policy and Research, AHCPR)^[100] While the AHCPR assessment endorsed the use of behavioral therapy as a first-line treatment of incontinence, and identified biofeedback as a component of behavioral therapy, the AHCPR did not specifically evaluate the independent contribution of biofeedback to an overall behavioral approach.

Stress, Urge or Mixed Urinary Incontinence                              Back to Criteria

Since the 2000 TEC Assessment, several additional randomized trials have been published on biofeedback as a treatment of urinary incontinence in women; findings support the conclusions of the TEC assessments. Studies by Aksac and colleagues in 2003 and by Wang and colleagues in 2004 compared pelvic floor muscle exercises (PME) to biofeedback-directed PME and did not find significant improvement in incontinence symptoms when biofeedback was added to PME.^[101,102] Aukee and colleagues published a study in 2004, also evaluating PME with and without biofeedback, but change in incontinence symptoms was not a primary efficacy outcome.^[103] At the 1-year follow-up, there was not a significant difference between groups in the number of women who were assessed as needing surgery for incontinence.

In 2010, Huebner and colleagues in Germany published a study comparing biofeedback-assisted PME with conventional electrical stimulation, biofeedback-assisted PME with dynamic electrical stimulation, and biofeedback-assisted PME alone.^[104] With conventional electrical stimulation, the electrical stimulation was applied when the patient was at rest, whereas dynamic electrical stimulation involved applying the stimulation while the patient was actively contracting. The study included 108 women with stress or mixed incontinence. The treatment period was 3 months, at which time 88 of 108 (81.5%) were evaluated. The primary outcome, change in quality of life, as measured by the King’s health questionnaire, did not differ significantly among groups. The quality of life scores decreased by a mean of 20.7 points in the group with conventional electrical stimulation, 24.8 points in the group with dynamic electrical stimulation, and 20.2 points in the group with only biofeedback-assisted PME. The groups also did not differ significantly on other outcome measures. This study did not include a group that received PME alone without biofeedback.

A 2011 Cochrane review found that women who received biofeedback were significantly more likely to report that their incontinence was improved or cured compared women who received PME alone.^[105] However, a number of significant design flaws in the 24 trials that met inclusion criteria (1583 women total) limit the reliability of the reported outcomes.  These flaws included:

• It was common for the women in the biofeedback arm to have more contact with healthcare professionals than those who did not receive biofeedback.
• Many of the trials were at moderate to high risk of bias.
• There was significant variation in the regimens proposed for feedback and biofeedback, and the intervention’s purpose and composition were often unclear.

The authors concluded that feedback or biofeedback may provide additional benefit to PME alone; however, further research is needed to differentiate whether the beneficial effect was due to feedback, biofeedback, or some other difference between the trial arms.

The National Institutes of Health released a conference statement stating that, “Pelvic floor muscle training and biofeedback are effective in preventing and reversing some pregnancy-related fecal and urinary incontinence for the first year after delivery.^[35] There is insufficient research on the sustained long-term benefits of pelvic floor muscle training or biofeedback on preventing fecal or urinary incontinence.”

A 2011 update the National Institute for Health and Clinical Excellence (NICE) guidance on management of urinary incontinence in women is in progress. The guidance currently in place stated that “evidence does not indicate additional benefit from biofeedback with PME in comparison with PME alone.”^[106] The guidance also noted the heterogeneity between studies, including biofeedback methods, probes, feedback provided (visual and/or auditory), and setting in which biofeedback was undertaken (home or clinic). Most data was related to biofeedback in conjunction with PME. One study found biofeedback alone to have no significant difference in outcomes compared with PME alone. The majority of RCTs comparing biofeedback-assisted PME with PME alone found no significant differences in subjective or objective cure, quality of life, or social activity index scores. Despite the lack of evidence of effectiveness, the Guidance Development Group stated the information provided by biofeedback “may assist motivation for some women” and should be considered in women who cannot actively contract pelvic floor muscles.  

Post-Prostatectomy Urinary Incontinence                                 Back to Criteria

A systematic review of PME to improve post-prostatectomy urinary incontinence discussed three studies (281 men) that focused on the incremental value of biofeedback over written/verbal PME.^[107] Although PME appeared to reduce the time to recover continence compared to no training, there was no evidence for an advantage of training with biofeedback over written/verbal instructions.

Two trials, summarized in detail below, have evaluated the combination of biofeedback and electrical stimulation in men with post-prostatectomy incontinence. The two trials had mixed findings. Mariotti et al. (2009) found a beneficial effect of the combined intervention of biofeedback and electrical stimulation, whereas the Goode et al. study did not find a benefit compared to behavioral therapy alone. Both studies were limited in that they did not isolate the effect of biofeedback, and thus the independent effect of biofeedback on outcomes cannot be determined.

Mariotti and colleagues conducted a randomized controlled trial comparing a program of pelvic floor electrical stimulation and electromyographic biofeedback (treatment group, n=30) to written/verbal instructions for pelvic muscle exercises (control group, n=30) with 6 months follow-up.^[108] The mean time to regain continence was significantly shorter in the treatment group (8.0 weeks) than the control group (13.9 weeks), p=0.003. The continence rate was significantly higher in the treatment group beginning at the 4-week visit and continuing through the 20-week visit at which time 29 of 30 (96.7%) in the treatment group and 18 of 30 (60%) in the control group were continent. The difference in the rate of continence was not statistically significantly different at the final, 6-month visit at which time 29 patients in the treatment group continued to be continent and 20 of 30 (66.7%) in the control group. This is one study suggesting that biofeedback in combination with pelvic electrical stimulation may shorten the time to continence after prostatectomy; however, the effect of biofeedback without electrical stimulation compared to written/verbal instructions to perform pelvic floor muscle exercises was not evaluated.

In 2011, Goode and colleagues published the results of a randomized trial comparing behavioral therapy alone to behavioral therapy in combination with biofeedback and pelvic floor electrical stimulation.^[109] The trial included 208 men with urinary incontinence (UI) persisting at least 1 year after radical prostatectomy. Men with pre-prostatectomy incontinence were excluded. Participants were randomized to 1 of 3 groups; 8 weeks of behavioral therapy (pelvic floor muscle training and bladder control exercises) (n=70), behavioral therapy plus biofeedback and electrical stimulation (n=70), and a delayed-treatment control group (n=68). The biofeedback and electrical stimulation intervention, called “behavior-plus,” consisted of in-office electrical stimulation with biofeedback using an anal probe and daily home pelvic floor electrical stimulation. After 8 weeks, patients in the 2 active treatment groups were given instructions for a maintenance program of pelvic floor exercises and fluid control and were followed up at 6 and 12 months. The primary efficacy outcome was reduction in the number of incontinent episodes at 8 weeks, as measured by a 7-day bladder diary. A total of 176 of 208 (85%) randomized men completed the 8 weeks of treatment. In an intention-to-treat analysis of the primary outcome, the mean reduction in incontinent episodes was 55% (28 to 13 episodes per week) in the behavioral therapy group, 51% (26 to 12 episodes per week) in the behavior-plus group, and 24% (25 to 20 episodes per week) in the control group. The overall difference between groups was statistically significant (p=0.001), but the behavior-plus intervention did not result in a significantly better outcome than behavioral therapy alone. Findings were similar on other outcomes. For example, at the end of 8 weeks, there was a significantly higher rate of complete continence in the active treatment groups (11 of 70, 16% in the behavior group and 12 of 70, 17% in the behavior-plus group) than the control group (4 of 68, 6%), but the group receiving biofeedback and electrical stimulation did not have a significantly higher continence rate than the group receiving behavioral therapy alone.

Other Urinary Incontinence                                                        Back to Criteria

A randomized study of 74 patients with multiple sclerosis reported that the addition of neuromuscular electrical stimulation with biofeedback training resulted in 85% incontinence reduction, compared to a 47% incontinence reduction in the control group trained only with biofeedback.^[110]

Other indications                                                                        Back to Criteria

Other indications for which there are no clinical trial publications sufficient to demonstrate the effectiveness of biofeedback include, but are not limited to the following:

• Cardiovascular disorders
• Chronic fatigue syndrome
• Chronic obstructive pulmonary disease (COPD)
• Depression
• Epilepsy
• Facial palsy
• Hand hemiplegia
• Low vision
• Post-traumatic stress disorder
• Side-effects of cancer chemotherapy

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CROSS REFERENCES

Neurofeedback, Regence Medical Policy Manual, Medicine, Policy No. 65

Transvaginal and Transurethral Radiofrequency Tissue Remodeling for Urinary Stress Incontinence, Regence Medical Policy Manual, Surgery, Policy No. 130

Posterior Tibial Nerve Stimulation for Voiding Dysfunction, Regence Medical Policy Manual, Surgery Policy No. 154

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