Allied Health - Biofeedback

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

DESCRIPTION

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

Back pain

Bruxism and sleep bruxism

Cardiovascular disorders

Chronic fatigue

Chronic pain

Chronic obstructive pulmonary disease (COPD)

Depression

Epilepsy

Facial palsy

Fecal incontinence in adults and children

Fibromyalgia

Hand hemiplegia

Hypertension

Insomnia

Knee pain

Low back pain

Low vision

Lupus [systemic lupus erythematosus (SLE)]

Movement disorders

Myalgia or muscle pain

Neck pain

Raynaud’s disease

Post-traumatic stress disorder (PTSD)

Side effects of cancer chemotherapy

Temporomandibular joint disorders

Urinary disorders

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

Vestibulodynia, vulvodynia, vulvar vestibulitis

POSITION SUMMARY

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. One method of measuring placebo effects associated with biofeedback is to conduct studies using a sham feedback treatment. Because patients may be simultaneously treated with more than one type of behavioral therapy (e.g., other relaxation techniques), it is challenging to isolate the independent contribution of biofeedback.

It is unknown whether biofeedback provides consistent, long-term improvement in health outcomes. 

1995 TEC Assessment                                                              Back to Criteria

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.
• 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.

Currently, there continues to be insufficient evidence to demonstrate the effectiveness of biofeedback for the disorders evaluated in the 1995 TEC assessment. Additional well-designed studies are needed using sham biofeedback and double-blinding for the following reasons:

• The extent to which any benefit from biofeedback can be attributed to nonspecific effects has not yet been resolved.
• Biofeedback may be an alternative method of performing relaxation training for various conditions, but studies have yet to determine whether adding biofeedback to conventional relaxation training improves outcome.
• Studies have not consistently addressed effects on key health outcomes rather than intermediate physiological outcome,
• Studies have not addressed the durability of effects beyond the initial short-term training period.

Other conditions not addressed in the 1995 TEC assessment include hand hemiplegia, facial palsy, low vision, cardiovascular disorders, chronic obstructive pulmonary disease, post-traumatic stress disorder, and epilepsy. However, there are no clinical trial publications sufficient to demonstrate the effectiveness of biofeedback in these other indications.

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 including possible selection bias, 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.

Chronic Pain                                                                              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 chronic pain.

The 1995 TEC Assessment concluded that evidence was insufficient to demonstrate the effectiveness of biofeedback for treatment of chronic pain. (6)

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. (8)  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 could not be isolated.

Knee pain                                                                                   Back to Criteria

Dursun and colleagues randomized 60 patients with knee pain to EMG biofeedback plus conventional exercise or conventional exercise alone. (9) There were no differences between groups on pain or function

Low Back Pain                                                                           Back to Criteria

The largest study of biofeedback in the treatment of lower back pain was published by Bush and colleagues who randomized 62 patients to receive either EMG biofeedback, sham biofeedback, or a no treatment control. (10) 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. The two smaller controlled trials (24 patients in each trial) of biofeedback for low back pain reported conflicting results. (11,12) The TEC assessment concluded the following:

• The available evidence did not clearly show whether biofeedback’s effects exceeded nonspecific placebo effects.
• It was also unclear whether biofeedback added to the effectiveness of relaxation training alone.

Since the 1995 TEC Assessment, new randomized, controlled trials on biofeedback in the treatment of low back pain are lacking.

Lupus                                                                                          Back to Criteria

Finally, 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). (13) 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. (14) 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. (15) 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. (16) 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                                                                     Back to Criteria

The relevant clinical outcome in studies of biofeedback as a treatment of fecal incontinence should be the overall change in the bowel incontinence. Changes in physiological assessment (e.g., anal pressure or sensory threshold) often do not correlate with symptom relief (i.e., clinical outcomes); therefore, anorectal physiology measurements are a poor proxy for changes in clinical symptoms. Reduction in episodes of fecal incontinence is 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. The published literature for biofeedback as a treatment of fecal incontinence in adults and children consist of case series, observational studies and systematic review. Due to numerous methodological flaws, these and 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 lack of randomization, lack of appropriate control groups for comparison, small sample size, short follow-up period, nonspecific treatment effects, and lack of validated outcome measures.

In addition, 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’." (17)

In summary, stronger research with more rigorous quality 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%.

Six systematic reviews of biofeedback treatment for fecal incontinence in adults have been published, including two Cochrane Reviews. (17-22)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). (23, 24) No greater benefit was found for biofeedback compared with standard care.

The conclusions from these six 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

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.” (25) 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”. (26) 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. (27) 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. Heyman and colleagues found no studies with control groups on children.  In two separate systematic reviews of a total of nine randomized trials (28-36) 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. (37,38) 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. (33) 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. (34) A 2006 updated literature review by the same authors confirmed the initial results. (39) 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. (40)

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

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. (41) In a randomized clinical trial of 143 females with fibromyalgia, van Santen and colleagues compared biofeedback and fitness training to usual care. (42) 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

This policy was initially based on a 1995 BlueCross BlueShield Association Technology Evaluation Center (TEC) Assessment (6), which concluded that evidence was insufficient to demonstrate the effectiveness of biofeedback for treatment of tension or migraine headaches. The available evidence did not clearly show whether biofeedback’s effects exceeded nonspecific placebo effects. It was also unclear whether biofeedback added to the effectiveness of relaxation training alone.

In 2007 and 2008, Nestoriuc and colleagues published systematic reviews of biofeedback for migraine and tension-type headaches. The meta-analysis for treatment of migraine included 55 studies (randomized, pre-post, and uncontrolled) and 39 controlled trials, reporting a medium effect size of 0.58 (pooled outcome of all available headache variables). (43) For treatment of tension-type headaches, 53 studies met criteria for analysis; these included controlled studies with standardized treatment outcomes, follow-up of at least three months, and at least four patients per treatment group. (44) Meta-analysis showed a medium-to-large effect size of 0.73 that appeared to be stable over 15 months of follow-up. Biofeedback was reported to be more effective than headache monitoring, placebo, and relaxation therapies. Biofeedback in combination with relaxation was more effective than biofeedback alone, and biofeedback alone was more effective than relaxation alone, suggesting different elements for the two therapies. Although these meta-analyses are limited by the inclusion of studies of poor methodological quality, the authors did not find evidence of an influence of study quality or publication bias in their findings.

Another meta-analysis assessed psychological treatments of recurrent tension headache or migraine in children. (45) Three studies were included that compared relaxation combined with biofeedback versus relaxation training alone. In general, small standardized effect sizes (0, 0.5, and 0.25) on frequency, intensity, and duration of headache were reported for the addition of biofeedback. Small standardized effect sizes were also reported for clinically significant changes (> 50% reduction) in headache. A 2006 systematic review of non-pharmacological treatments for migraine concluded that the current literature does not show clear effectiveness of biofeedback for migraine in children. (46)

Martin and colleagues compared cognitive behavioral therapy (CBT) versus temporal pulse amplitude (TPA) biofeedback or wait-list control among patients who volunteered for a study of psychological treatments. (47) Thirty patients with migraine and 21 with tension-type headaches were randomized to one of the three treatments. There was a 20% dropout rate, with no significant difference in loss to follow-up among the groups. Patient logs showed an average reduction in headaches of 68% for the CBT group, 56% for biofeedback, and 20% for the control condition. Clinically significant improvement, defined as at least 50% reduction in either headache rating or medication use, was observed in 78% of the CBT group, 63% of the biofeedback group, and 23% of the control group. The cognitive mediators (self-efficacy and locus of control) that had been hypothesized to underlie efficacy of both biofeedback and CBT were not found to be associated with improvement for either treatment. Statistical analysis was limited by the small group sizes.

Physician Specialty Society Guidelines

The National Institute of Neurologic Disorders and Stroke (2008) state that when headaches occur three or more times a month, preventive treatment is usually recommended. (48) “Drug therapy, biofeedback training, stress reduction, and elimination of certain foods from the diet are the most common methods of preventing and controlling migraine and other vascular headaches. Drug therapy for migraine is often combined with biofeedback and relaxation training.”

The American Academy of Family Physicians (AAFP) 2000 guidelines on preventive therapy for migraines, based on evidence review by the U.S. Headache Consortium, recommend relaxation training, thermal biofeedback combined with relaxation training, EMG biofeedback, and cognitive-behavioral therapy as treatment options for prevention of migraine (Grade A recommendation). (49,50) Relaxation techniques and biofeedback may be combined with preventative drug therapy to achieve additional clinical improvement (Grade B recommendation). According to the guidelines, nonpharmacologic therapy may be well suited for patients who have exhibited a poor tolerance or poor response to drug therapy, who have a medical contraindication to drug therapy, and who have a history of long-term, frequent or excessive use of analgesics or other acute medications. Nonpharmacologic intervention may also be useful in patients with significant stress or in patients who are pregnant, are planning to become pregnant, or are nursing.

The American Academy of Neurology’s (AAN) recommendations for the evaluation and treatment of migraine headaches states that behavioral and physical interventions are used for preventing migraine episodes rather than for alleviating symptoms once an attack has begun. (51) Although these modalities may be effective as monotherapy, they are more commonly used in conjunction with pharmacologic management. Relaxation training, thermal biofeedback combined with relaxation training, electromyographic biofeedback, and cognitive-behavioral therapy may be considered treatment options for prevention of migraine. Specific recommendations regarding which of these to use for specific patients cannot be made.

Hypertension                                                                             Back to Criteria

Randomized controlled trials are currently limited to small, short-term studies that do not permit scientific conclusions.

Two studies used the same sample of patients with mild, unmedicated essential hypertension. (52,53) 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. 

The most recent meta-analysis, Rainforth and colleagues reviewed randomized, controlled trials and all previous meta-analyses related to stress reduction programs including biofeedback. (54) Each type of therapy was analyzed separately.  No significant reduction in blood pressure was achieved using biofeedback alone or biofeedback combined with relaxation training.

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. (55-58) A Cochrane review assessing EMG biofeedback for the recovery of motor function after stroke included thirteen randomized or quasi-randomized studies. (59) 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.

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. (60) 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.

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. (61) Since biofeedback was not isolated from other therapies, no conclusions could be reached for biofeedback alone. McNeely and colleagues also conducted a systematic review. (62) 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.

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. (63) 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 (64) 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. (65)

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) (66) 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

Additional trials published since the 2000 TEC Assessment have reported favorable outcomes with biofeedback plus pelvic floor exercises for stress or urge incontinence, but these studies have not examined the incremental effect of adding biofeedback to PME. (67-69) One small, randomized study (n=40) compared individual biofeedback plus PME to group physical therapy focusing on PME. (70) Mixed results were reported with the biofeedback group demonstrating better subjective outcomes and the physical therapy group having slightly better objective outcomes. The results were limited at best and mitigated by possible confounding introduced by individual versus group therapies, the lack of standard outcome measures (i.e., pad test), and possible bias introduced by a high rate of exclusions from the biofeedback group.

Aksac and colleagues reported the results of a trial that randomized 50 patients with stress incontinence to one of three groups: self-directed PME, biofeedback-directed PME, or no treatment. (71) The first two groups had a significant improvement in outcomes compared to the control (no treatment) group.  The biofeedback group had increased strength in the pelvic floor muscles compared to those with self-directed PME, but the clinical significance of this difference was unclear. Two studies with a total of 325 patients that attempted to isolate the specific contribution of biofeedback to the overall treatment effect for urinary incontinence found no significant difference in outcomes between patients treated with behavioral interventions that included biofeedback and behavioral interventions that did not include biofeedback. (72,73)

The Medicare Coverage Advisory Committee (MCAC), Medical/Surgical Procedures Panel, evaluated the effectiveness of biofeedback for urinary incontinence in April 2000. (74) Based strictly on the scientific evidence, the Panel concluded that it was not clear that biofeedback added clinical benefit above and beyond PME alone for stress, urge, or post-prostatectomy incontinence.

Other evidence-based reviews on the effectiveness of biofeedback for urinary incontinence have found limited evidence or no evidence supporting a beneficial effect beyond that offered by PME alone. A Cochrane review concluded that formal comparisons of biofeedback-assisted PME versus PME alone consistently suggested that there was no added benefit in women with stress or mixed incontinence. (75) Berghmans and colleagues published a systematic review with qualitative data synthesis. (76) These authors concluded that there was strong evidence that the addition of biofeedback to pelvic floor muscle exercises (PME) did not offer additional benefits over PME alone. Weatherall performed a quantitative meta-analysis of the data included in the Berghmans report. (77) This analysis revealed a pooled odds ratio of 2.1 in favor of biofeedback, a result that reached marginal statistical significance.

Post-Prostatectomy Urinary Incontinence                                 Back to Criteria

Since the 2000 TEC assessment, three randomized trials compared PME plus biofeedback to PME alone in a total of 271 post prostatectomy patients. (78-80) These studies reported that the addition of biofeedback did not improve outcomes compared to PME alone.  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. (81) 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.

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. (82)

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:

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

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.27
2. BlueCross BlueShield Association Medical Policy Reference Manual; Policy No. 2.01.29
3. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.30
4. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.53
5. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 2.01.64
6. BlueCross and BlueShield Association Technology Evaluation Center TEC Assessment: Biofeedback. 1995; Vol. 10 Tab 25
7. Lehrer PM, Vaschillo E, Vaschillo B, Lu S, Scardella A, Siddique M, Habib RH. Biofeedback treatment for asthma. Chest 2004;126:352-61
8. Astin JA, Beckner W, Soeken K et al. Psychological interventions for rheumatoid arthritis: a meta-analysis of randomized controlled trials.  Arthritis Rheum  2002;47(3):291-302
9. Dursun N, Dursun E, Kilic Z. Electromyographic biofeedback-controlled exercise versus conservative care for patellofemoral pain syndrome.  Arch Phys Med Rehabil 2001;82(12):1692-5
10. Bush C, Ditto B, Feuerstein M. A controlled evaluation of paraspinal EMG biofeedback in the treatment of chronic low back pain.  Health Psychol 1985;4(4):307-21
11. Stuckey SJ, Jacobs A, Goldfarb J. EMG biofeedback training, relaxation training, and placebo for the relief of chronic back pain.  Percept Mot Skills 1986;63(3):1023-36
12. Flor H, Haag G, Turk DC et al. Efficacy of EMG biofeedback, pseudotherapy, and conventional medical treatment for chronic rheumatic back pain.  Pain 1983;17(1):21-31
13. Greco CM, Rudy TE, Manzi S.  Effects of a stress-reduction program on psychological function, pain, and physical function of systemic lupus erythematosus patients: a randomized controlled trial.  Arthritis Rheum 2004;51(4):625-34
14. Humphreys PA, Gevirtz RN. Treatment of recurrent abdominal pain: components analysis of four treatment protocols.  J Pediatr Gastroenterol Nutr 2000;31(1):47-51
15. Weydert JA, Ball TM, Davis MF. Systematic review of treatments for recurrent abdominal pain.  Pediatrics 2003;111(1):e1-11
16. Bergeron S, Binik YM, Khalife S et al. A randomized comparison of group cognitive-behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis.  Pain 2001;91(3):297-306
17. Norton C, Kamm MA. Anal sphincter biofeedback and pelvic floor exercises for faecal incontinence in adults – a systematic review. Aliment Pharmacol Ther 2001;15(8):1147-54
18. Heymen S, Jones KR, Ringel Y et al. Biofeedback treatment of fecal incontinence: a critical review. Dis Colon Rectum 2001;44(5):728-36
19. Shamliyan T, Wyman J, Bliss DZ et al. Prevention of urinary and fecal incontinence in adults. Evid Rep Technol Assess (Full Rep). 2007;(161):1-379. AHRQ Publication No. 08-E003
20. Coulter ID, Favreau JT, Hardy ML et al. Biofeedback interventions for gastrointestinal conditions: a systematic review. Altern Ther Health Med 2002;8(3):76-83
21. Norton C, Hosker G, Brazzelli M. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software
22. Norton C, Cody JD, Hosker G. Biofeedback and/or sphincter exercises for the treatment of faecal incontinence in adults (Cochrane Review). In: Cochrane Database of Systematic Reviews 2006, Issue 3. Art No.; CD002111
23. Norton C, Chelvanayagam S, Wilson-Barnett J et al. Randomized controlled trial of biofeedback for fecal incontinence. Gastroenterology 2003;125(5):1320-9
24. Solomon MJ, Pager CK, Rex J, et.al.  Randomized controlled trial of biofeedback with anal manometry, transanal ultrasound, or pelvic floor retraining with digital guidance alone in the treatment of mild to moderate fecal incontinence. Dis Colon Rectum 2003;46:703-10
25. Landefeld CS, Bowers BJ, Feld AD, et al. National Institutes of Health state-of-the-science conference statement on prevention of fecal and urinary incontinence in adults. Ann Intern Med. 2008 Mar 18;148(6):449-58
26. National Institute for Health and Clinical Excellence (NICE). Guideline 49: Fecal incontinence: the management of fecal incontinence in adults, June 2007. Available at: www.nice.org.uk
27. Tjandra JJ, Dykes SL, Kumar RR et al.; Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters for the treatment of fecal incontinence. Dis Colon Rectum 2007;50(10):1497-507
28. Wald A, Chandra R, Gabel S et al. Evaluation of biofeedback in childhood encopresis. J Pediatr Gastroenterol Nutr 1987;6(4):554-8
29. van der Plas RN, Benninga MA, Redekop WK et al. Randomized trial of biofeedback training for encopresis. Arch Dis Child 1996;75(5):367-74
30. van der Plas RN, Benninga MA, Buller HA et al. Biofeedback training in treatment of childhood constipation: a randomised controlled study. Lancet 1996;348(9030):776-80
31. Nolan T, Catto-Smith T, Coffey C et al. Randomised controlled trial of biofeedback training in persistent encopresis with anismus. Arch Dis Child 1998;79(2):131-5
32. Loening-Baucke V, Desch L, Wolraich M. Biofeedback training for patients with myelomeningocele and fecal incontinence. Dev Med Child Neurol 1988;30(6):781-90
33. Loening-Baucke V. Modulation of abnormal defecation dynamics by biofeedback treatment in chronically constipated children with encopresis. J Pediatr 1990;116(2):214-22
34. Loening-Baucke V. Biofeedback treatment for chronic constipation and encopresis in childhood: long-term outcome. Pediatrics 1995;96(1):105-10
35. Davila E, de Rodriguez GG, Adrianza A et al. [The usefulness of biofeedback in children with encopresis. A preliminary report.] GEN [Revista de la Sociedad Venezolana de Gastroenterologia] 1992; 46(4):297-301. Spanish
36. Cox DJ, Sutphen J, Borowitz S et al. Contribution of behavior therapy and biofeedback to laxative therapy in the treatment of pediatric encopresis. Ann Behav Med 1998;20(2):70-6
37. Coulter ID, Favreau JT, Hardy ML et al. Biofeedback interventions for gastrointestinal conditions: a systematic review. Altern Ther Health Med 2002;8(3):76-83
38. Brazzelli M, Griffiths P. Behavioral and cognitive interventions with or without other treatments for defaecation disorders in children (Cochrane Review). In: The Cochrane Library, Issue 2, 2003. Oxford: Update Software
39. Brazelli M, Griffiths P. Behavioural and cognitive interventions with or without other treatments for the management of faecal incontinence in children. Cochrane Database of Systematic Reviews 2006, 19(2): Art No.; CD002240
40. Borowitz SM, Cox DJ, Sutphen JL et al. Treatment of childhood encopresis: a randomized trial comparing three treatment protocols. J Pediatr Gastroenterol Nutr 2002;34(4):378-84
41. Buckelew SP, Conway R, Parker J et al. Biofeedback/relaxation training and exercise interventions for fibromyalgia: a prospective trial.  Arthritis Care Res 1998;11(3):196-209
42. van Santen M, Bolwijn P, Verstappen F et al. A randomized clinical trial comparing fitness and biofeedback training versus basic treatment in patients with fibromyalgia.  J Rheumatol  2002;29(3):575-81
43. Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. 2007;128(1-2):111-27
44. Nestoriuc Y, Rief W, Martin A. Meta-analysis of biofeedback for tension-type headache: efficacy, specificity, and treatment moderators. J Consult Clin Psychol 2008;76(3):379-96
45. Trautmann E, Lackschewitz H, Droner-Herwig B. Psychological treatment of recurrent headache in children and adolescents--a meta-analysis. Cephalalgia. 2006;26(12):1411-26
46. Damen L, Bruijn J, Koes BW, et al. Prophylactic treatment of migraine in children. Part 1. A systematic review of non-pharmacological trials. Cephalalgia. 2006;26(4):373-83
47. Martin PR, Forsyth MR, Reece J. Cognitive-behavioral therapy versus temporal pulse amplitude biofeedback training for recurrent headache. Behav Ther 2007;38(4):350-63
48. National Institute of Neurologic Disorders and Stroke. Headache information page. Available at: http://www.ninds.nih.gov/disorders/headache/headache.htm (Verified 6/23/09)
49. Morey SS. Practice guidelines of the American Academy of Family Physicians. Guidelines on migraine: part 4. General principles of preventive therapy. Am Fam Physician 2000;62(10):2359-60, 2363
50. Campbell JK, Penzien DB, Wall EM. Evidenced-based guidelines for migraine headache: behavioral and physical treatments. U.S. Headache Consortium 2000. Available at: http://www.aan.com/professionals/practice/pdfs/gl0089.pdf (Verified 6/23/09)
51. Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology 2000;55(6): 754-762
52. Henderson RJ, Hart MG, Lal SK et al. The effect of home training with direct blood pressure biofeedback of hypertensives: a placebo-controlled study. J Hypertens 1998;16(6):771-8
53. Hunyor SN, Henderson RJ, Lal SK et al. Placebo-controlled biofeedback blood pressure effect in hypertensive humans. Hypertension 1997;29(6):1225-31
54. Rainforth MV, Schneider RH, Nidich SI, et al. Stress reduction programs in patients with elevated blood pressure: a systematic review and meta-analysis. Curr Hypertens Rep. 2007;9(6):520-8
55. Bradley L, Hart BB, Mandana S et al. Electromyographic biofeedback for gait training after stroke. Clin Rehabil 1998;12(1):11-22
56. Wong AM, Lee MY, Kuo JK et al. The development and clinical evaluation of a standing biofeedback trainer. J Rehabil Res Dev 1997;34(3):322-7
57. Geiger RA, Allen JB, O’Keefe J et al. Balance and mobility following stroke: effects of physical therapy interventions with and without biofeedback/forceplate training. Phys Ther 2001; 81(4):995-1005
58. Kohlmeyer KM, Hill JP, Yarkony GM et al. Electrical stimulation and biofeedback effect on recovery of tenodesis grasp: a controlled study. Arch Phys Med Rehabil 1996;77(7):702-6
59. Woodford H, Price C. EMG biofeedback for the recovery of motor function after stroke. Cochrane Database Syst Rev. 2007;18(2):CD004585
60. Raynaud’s Treatment Study Investigators. Comparison of sustained-release nifedipine and temperature biofeedback for treatment of primary Raynaud phenomenon. Results from a randomized clinical trial with 1-year follow-up. Arch Intern Med 2000;160(8):1101-8
61. Medicott MS, Harris SR. A systematic review of the effectiveness of exercise, manual therapy, electrotherapy, relaxation training, and biofeedback in the management of temporomandibular disorder.  Phys Ther 2006;86(7):955-73
62. McNeely ML, Armijo OS, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther 2006;86(5):710-25
63. BlueCross and BlueShield Association Technology Evaluation Center TEC Assessment: Biofeedback in the Treatment of Adult Urinary Incontinence. 1997; Vol. 11, Tab 23
64. BlueCross and BlueShield Association Technology Evaluation Center TEC Assessment: Biofeedback in the Treatment of Urinary Incontinence in Adults. 2000; Vol. 14, Tab 3
65. Franke JJ, Gilbert WB, Grier J et al. Early post-prostatectomy pelvic floor biofeedback. J Urol 2000;163(1):191-3
66. Fantl JA, Newman DK, Colling J et al. Urinary incontinence in adults: Acute and chronic management. Clinical practice guideline, No. 2, 1996 update. Rockville, MD. Agency for Health Care Policy and Research, Public Health Service, U.S. Department of Health and Human Services, 1996
67. Burgio KL, Locher JL, Goode PS et al. Behavioral vs. drug treatment for urge urinary incontinence in older women: a randomized controlled trial. JAMA 1998;280(23):1995-2000
68. Burgio KL, Locher JL, Goode PS. Combined behavioral and drug therapy for urge incontinence in older women. J Am Geriatr Soc 2000;48(4):370-4
69. McDowell BJ, Engberg S, Sereika S et al. Effectiveness of behavioral therapy to treat incontinence in homebound older adults. J Am Geriatr Soc 1999;47(3):309-18
70. Pages IH, Jahr S, Schaufele MK et al. Comparative analysis of biofeedback and physical therapy for treatment of urinary stress incontinence in women. Am J Phys Med Rehabil 2001;80(7):494-502
71. Aksac B, Aki S, Karan A et al.  Biofeedback and pelvic floor exercises for the rehabilitation of urinary stress incontinence.  Gynecol Obstet Invest 2003;56:23-7
72. Morkved S, Bo K, Fjortoft T. Effect of adding biofeedback to pelvic floor muscle training to treat urodynamic stress incontinence.  Obstet Gynecol. 2002;100(4):730-9
73. Burgio KL, Goode PS, Locher JL, et al. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA. 2002;288(18):2293-9
74. Centers for Medicare and Medicaid Services. Medicare Coverage Policy: Biofeedback for urinary incontinence (CAG-00020N).  Decision Memorandum.  October 6, 2000. Available online at www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=12  (Verified 3/9/09)
75. Hay-Smith EJC, Bo K, Berghamans LCM et al. Pelvic floor muscle training for urinary incontinence in women (Cochrane Review). In: The Cochrane Library, Issue 3, 2002
76. Berghmans LC, Hendriks HJ, Bo K et al. Conservative treatment of stress urinary incontinence in women: a systematic review of randomized clinical trials. Br J Urol 1998;82(2):181-91
77. Weatherall M. Biofeedback or pelvic floor muscle exercises for female genuine stress incontinence and sexual function after anatomic radical prostatectomy: a meta-analysis of trials identified in a systematic review. BJU Int 1999;83(9):1015-6
78. Wille S, Sobottka A, Heidenreich A, Hofmann R.  Pelvic floor exercises, electrical stimulation and biofeedback after radical prostatectomy: results of a prospective randomized trial.  J Urol  2003;170:490-3
79. Floratos DL, Sonke GS, Rapidou CA et al. Biofeedback vs. verbal feedback as learning tools for pelvic muscle exercises in the early management of urinary incontinence after radical prostatectomy. BJU Int 2002;89(7):714-9
80. Bales GT, Gerber GS, Minor TX et al. Effect of preoperative biofeedback/pelvic floor training on continence in men undergoing radical prostatectomy. Urology 2000;56(4):627-30
81. MacDonald R, Fink HA, Huckabay C et al. Pelvic floor muscle training to improve urinary incontinence after radical prostatectomy: a systematic review of effectiveness. BJU Int 2007;100(1):76-81
82. McClurg D, Ashe RG, Lowe-Strong AS. Neuromuscular electrical stimulation and the treatment of lower urinary tract dysfunction in multiple sclerosis- A double blind, placebo controlled, randomised clinical trial. Neurourol Urodyn 2008;27(3):231-7

Cross References

None

Allied Health Table of Contents