Coverage Policy Manual
Policy #: 2009027
Category: Medicine
Initiated: August 2009
Last Review: April 2023
  Biofeedback as a Treatment of Chronic Pain
Description:
Biofeedback is a technique intended to teach patients self-regulation of certain physiologic processes not normally considered to be under voluntary control. Electromyography biofeedback has been evaluated as a method to reduce chronic or recurrent pain of musculoskeletal or psychosomatic origin.
 
Biofeedback is a technique intended to teach patients the self-regulation of certain unconscious or involuntary physiologic processes. Biofeedback equipment converts physiological signals into outputs given to patients. The technique involves the feedback of a variety of types of information not usually available to the patient, followed by a concerted effort on the part of the patient to use this feedback to help alter the physiologic process in a specific way. Biofeedback has been proposed as a treatment for a variety of diseases and disorders including anxiety, headaches, hypertension, movement disorders, incontinence, pain, asthma, Raynaud disease, and insomnia. The type of feedback used in an intervention (e.g., visual, auditory) depends on the nature of the disease or disorder being treated.
 
Biofeedback may be administered, using different techniques and monitoring devices and sensors (e.g., electromyograph), in an outpatient setting by psychiatrists, psychologists, and general practitioners. 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. Sessions can take up to 90 minutes. Training sessions are performed in a quiet, nonstimulating environment. Patients are instructed to use mental imagery techniques to affect the physiologic variable being monitored, and feedback is provided for the successful alteration of that physiologic parameter in the form of lights or tone, verbal praise, or other auditory or visual stimuli. This evidence review focuses on the use of biofeedback for the treatment of chronic pain.
 
Treatment for chronic pain is often multimodal, and typically includes psychological therapy. Psychological techniques vary, but may include cognitive therapy, which teaches subjects the ability to cope with stressful stimuli by attempting to alter negative thought patterns and dysfunctional attitudes, and behavioral approaches to reduce muscle tension and break the pain cycle. Relaxation, using any of a variety of techniques including meditation or mental imagery, is considered a behavioral therapy that may be used alone or as a component of a cognitive-behavioral therapy program. Electromyography biofeedback has also been used for the treatment of chronic pain, on the assumption that the ability to reduce muscle tension will be improved through the feedback of data to the patient regarding the degree of muscle tension. While some consider electromyography biofeedback to be a method used to obtain relaxation, others consider biofeedback to be distinct from other relaxation techniques.
 
Regulatory Status
A large number of biofeedback devices have received FDA clearance through the 510(k) process since 1976. FDA product code: HCC
Policy/
Coverage:
Biofeedback for any condition is an exclusion in most member benefit certificates.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Biofeedback for treatment of chronic pain (including but not limited to low back pain) or any other condition does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, biofeedback for treatment of chronic pain (including but not limited to low back pain) or any other condition is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
For member benefit certificates without this specific contract exclusion, biofeedback as a treatment of chronic pain, including but not limited to low back pain, is investigational.  Investigational services are not covered.
 
Rationale:
Current approaches to treatment of chronic pain are multidisciplinary. Behavioral and psychological interventions are now a standard component of therapy in the majority of centers treating chronic pain in the United States. Among behavioral, i.e., non-drug approaches to pain management, a variety of options are available in addition to biofeedback. Relaxation techniques are similar to biofeedback in that the intent of each is to teach the subject to break the pain/spasm cycle by reducing muscle tension.
 
Behavioral treatments involve 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 subject and the 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. Because an ideal placebo control is problematic with behavioral treatments, and because treatment of chronic pain is typically multimodal, isolating the specific contribution of biofeedback is difficult.
 
The National Institutes of Health (NIH) convened a technology assessment panel in 1996, entitled “Integration of Behavior and Relaxation Approaches into the Treatment of Chronic Pain and Insomnia.”  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.”
 
This policy was originally based on a 1996 TEC Assessment, which concluded that evidence was insufficient to demonstrate the effectiveness of biofeedback for treatment of chronic pain. 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.
 
Lower Back Pain
The largest study of biofeedback in the treatment of lower back pain was published by Bush and colleagues who randomized 62 patients to either EMG biofeedback, sham biofeedback, or a no treatment control group.  At the conclusion of the trial, all 3 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. Two smaller controlled trials (24 patients in each trial) of biofeedback for low back pain reported conflicting results.  Controlled trials on low back pain after 1996 are lacking.
 
Fibromyalgia
Buckelew et al assessed the use of biofeedback for fibromyalgia with a total of 119 patients who were randomly assigned to 1 of 4 treatment groups: 1) biofeedback/relaxation, 2) exercise training, 3) combination treatment, and 4) an educational/attention control program.  While the combination treatment group had better tender point index scores than other treatment groups, this study does not address placebo effects or the impact of adding biofeedback to relaxation therapy. In a randomized clinical trial of 143 females with fibromyalgia, biofeedback and fitness training were compared to usual care by van Santen and colleagues.  The primary outcome evaluated was pain using a visual analogue scale. The authors reported no clear improvements in objective or subjective patient outcomes with biofeedback (or fitness training) over usual care. A small double-blinded randomized trial from Asia compared actual and sham biofeedback on pain, fitness, function, and tender points in 30 patients with fibromyalgia. (8) There was a trend for greater improvement in the active biofeedback group, but only the number of tender points (change of 8.6 active vs. 4.4 sham) was significantly different between the groups. The authors calculated that a sample size of 15 patients could detect a difference of 5 cm (10 cm max) on a visual analogue scale, suggesting that the study lacked adequate power. This study did not address biofeedback–assisted relaxation in comparison with relaxation training alone.
 
Abdominal Pain
Humphreys and Gevirtz randomly assigned 64 patients to groups treated with increased dietary fiber; fiber and biofeedback; fiber, biofeedback, and cognitive-behavioral therapy; or fiber, biofeedback, cognitive-behavioral therapy, and parental support. The 3 multicomponent 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, Weydert and colleagues concluded that behavioral interventions (cognitive-behavioral therapy and biofeedback) have a general positive effect on nonspecific recurrent abdominal pain and are safe.  The specific effects of biofeedback were not isolated in this systematic review and cannot be assessed.
 
Temporomandibular Joint Syndrome
A systematic review of therapies for temporomandibular joint (TMJ) disorders grouped interventions into 3 categories (exercise, electrotherapy, and biofeedback).  Due to the heterogeneous and frequently multiple interventions used in the reviewed studies, no conclusions could be reached for biofeedback alone without other relaxation techniques. Another systematic review concluded (from 2 low-quality randomized controlled trials) 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.  
 
Rheumatoid Arthritis
In a meta-analysis of psychological interventions for rheumatoid arthritis including relaxation, biofeedback, and cognitive-behavioral therapy, Astin and colleagues found psychological interventions may be important adjunctive therapies in rheumatoid arthritis treatment.  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 cannot be isolated.
 
Systemic Lupus
In a randomized controlled trial of 92 patients with systemic lupus erythematosus (SLE), Greco and colleagues found patients treated with 6 sessions of biofeedback-assisted cognitive-behavioral treatment for stress-reduction had statistically significant greater improvements in pain post-treatment than a symptom-monitoring support group (p=0.044) and a usual care group (p=0.028).  However, these improvements in pain were not sustained at 9 months’ follow-up, and further studies are needed to determine the incremental benefits of biofeedback-assisted cognitive-behavioral treatment over other interventions in patients with SLE.
 
Knee Pain
Dursun et al randomized 60 patients with knee pain to either EMG biofeedback plus conventional exercise or conventional exercise alone. There were no differences between groups on pain or function.
 
Vulvar vestibulitis
A randomized study by Bergeron of 78 patients with vulvar vestibulitis compared biofeedback, surgery, and cognitive-behavioral therapy.  Patients who underwent surgery had significantly better pain scores than patients who received biofeedback or cognitive-behavioral therapy. No placebo treatment was used.
 
In summary, relaxation training with biofeedback has been investigated as a treatment for a variety of chronic pain conditions. However, there is a lack of randomized controlled trials in this area, and questions remain about the contribution of biofeedback over relaxation training alone. The scientific evidence available at this time does not permit conclusions regarding the effect of this technology on health outcomes. Therefore, the policy statement is unchanged.
 
2011 Update
Biofeedback remains a contract exclusion in most member benefit certificates of coverage.  This policy is maintained for those contracts where biofeedback is not an exclusion.  A literature search was conducted in which no new literature was identified that would prompt a change in the coverage statement. A summary of the key identified literature is included below.
 
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 (Henschke, 2010).  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.
 
In 2010, Kapitza and colleagues compared the efficacy of respiratory biofeedback to sham biofeedback in 42 patients with lower back pain (Kapitza, 2010).  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.
 
Finally, a small RCT (40 patients) assessed whether the addition of biofeedback to strengthening exercises improved outcomes in patients with osteoarthritis; no differences between the 2 treatment conditions were found (Yilmaz, 2010).
 
2014 Update
A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below
 
In 2013, Glombiewski et al published a meta-analysis of studies on the efficacy of EMG and EEG biofeedback (ie, neurofeedback) for treating patients with fibromyalgia (Globiewski, 2013). The authors identified 7 RCTs comparing biofeedback with a control condition in patients with fibromyalgia syndrome. Studies in which biofeedback was evaluated only as part of multicomponent interventions were excluded from the review. Three studies used EEG biofeedback and 4 used EMG biofeedback; there were a total of 321 patients. A sham intervention was used as a control condition in 4 studies, 2 using EEG biofeedback and 2 using EMG- biofeedback. In a pooled analysis of the studies using EMG biofeedback, biofeedback significantly reduced pain intensity compared with a comparison intervention (effect size, Hedges g, 0.86; 95% CI, 0.11 to 0.62). A pooled analysis of studies on EEG biofeedback did not find a significant benefit compared with control conditions. Pooled analyses of studies of EMG and EEG biofeedback did not find a significant benefit of the intervention on other outcomes including sleep problems, depression and health-related quality of life. None of the studies included in this review were high quality, with risk of bias assigned by the authors as either unclear or high for all included studies. In addition, all of the studies reported on short-term outcomes, resulting in a lack of evidence on whether longer-term outcomes are improved. (For more information on EEG-biofeedback, see Policy 1998044.)
 
A 2011 guideline by the American College of Occupational and Environmental Medicine recommended biofeedback for “select patients with chronic low back pain as a component (not a separate procedure) of cognitive behavioral therapy (CBT) or as a procedure in the context of an interdisciplinary or functional rehabilitation program.” Biofeedback was not recommended for acute or subacute pack pain (ACEOM, 2011).
  
2015 Update
A literature search conducted through February 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Several trials with active comparison groups have not found that biofeedback is superior to alternative treatments. More recently, in 2015, Tan and colleagues evaluated 3 self-hypnosis interventions and included EMG biofeedback as a control intervention (Tan, 2015). The study enrolled 100 patients with chronic low back-pain. After the 8-week intervention, reported reductions in pain intensity were significantly higher in the hypnosis groups combined compared with the biofeedback group (p=0.042).
 
2016 Update
A literature search conducted using the MEDLINE database through March 2016 did not reveal any new information that would prompt a change in the coverage statement.  
 
2018 Update
A literature search conducted through March 2018 did not reveal any new information that would prompt a change in the coverage statement.
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through March 2020.  There was no new information identified that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
Ribeiro and Silva published an RCT assessing whether visual feedback improves range of motion in patients with chronic idiopathic neck pain (Ribeiro and Silva, 2019). Forty-two patients from a single Portuguese clinic were included in the study and randomly assigned to either the visual feedback group (n=21) or the control group (n=21). The interventions consisted of ten repetitions of various neck movements with visual feedback of the posterior neck region or the same number of movements without visual feedback. There was no significant interaction between time and intervention (p=0.297) and no effect of time on pain intensity (p=0.729). However, there was significant interaction between time and intervention for all the neck movements: flexion (p<0.001), extension (p<0.001), right side flexion (p<0.001), left side flexion (p<0.001), right rotation (p<0.001), and left rotation (p<0.001). The study was limited by its small sample size, short duration of intervention, and by the researcher assessing patients not being blinded.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The following therapies are currently being used to treat chronic pain: pharmacologic and nonpharmacologic therapy. For chronic pain management, a multimodal, multidisciplinary approach that is individualized to the patient is recommended (USHHS, 2019). A multimodal approach to pain management consists of using treatments (ie, nonpharmacologic and pharmacologic) from 1 or more clinical disciplines incorporated into an overall treatment plan. This allows for different avenues to address the pain condition, often enabling a synergistic approach that impacts various aspects of pain, including functionality. The efficacy of such a coordinated, integrated approach has been documented to reduce pain severity, improve mood and overall quality of life, and increase function.
 
The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) recommends that chronic pain trials should consider assessing outcomes representing 6 core domains: pain, physical functioning, emotional functioning, participant ratings of improvement and satisfaction with treatment, symptoms and adverse events, and participant disposition (Dworkin, 2005). The provisional benchmarks for interpreting changes in chronic pain clinical trial outcome measures per IMMPACT are as follows: Pain intensity measured by 0 to 10 numeric rating scale (10 to 20% decrease in pain is considered minimally important, 30% or more decrease in pain is considered moderately important, and 50% or more decrease in pain is considered substantial); Physical functioning is measured by Multidimensional Pain Inventory Interference Scale and Brief Pain Inventory Interference Scale (0.6 point or more decrease considered clinically important and 1 point decrease is considered minimally important); Emotional Functioning is assessed by Beck Depression Inventory, Profile of Mood States, Total Mood Disturbance, and Specific Subscales (5 point or more decrease considered clinically important, 10-15 point or more decrease considered clinically important, and 2-12 point or more change considered clinically important); and Global Rating of Improvement measured by Patient Global Impression of Change (Minimally improved change is considered minimally important, Much improved change is considered moderately important, and Very much improved change is considered substantial) (Dworkin, 2008).
 
Several meta-analyses have reviewed RCTs assessing psychological therapies for a variety of nonheadache chronic pain conditions. A Cochrane review by Williams et al focused on chronic pain in adults (Williams, 2020). Two RCTs were identified that compared behavioral therapy with an active control designed to change behavior (ie, exercise or instruction). Three RCTs had sufficient follow-up to be included in a comparison of behavioral therapy and usual treatment. Reviewers found no evidence that behavioral therapy had any effect on pain compared to active control or usual treatment. Additionally, there was no evidence of a difference between behavioral therapy and active control or usual treatment in terms of disability at the end of treatment.
 
Another Cochrane review by Fisher et al focused on children and adolescents with chronic and recurrent pain (Fisher, 2018). Although psychological therapies were found to improve pain, only 1 study evaluated biofeedback in nonheadache pain.
 
In 2020, the American College of Occupational and Environmental Medicine updated their guideline on noninvasive and minimally invasive management of low back disorders (Hegmann, 2020). The role of biofeedback is not addressed in this updated guideline.
 
In 2020, the U.S. Department of Veterans Affairs and U.S. Department of Defense published a guideline on the diagnosis and treatment of low back pain (Pangarkar, 2019). The guideline recommends several nonpharmacologic therapies for chronic low back pain (eg, CBT and/or mindfulness-based stress reduction, progressive relaxation, exercise including yoga, pilates, and tai chi) but does not address the role of biofeedback.
 
In 2020, the North American Spine Society published a guideline for the diagnosis and treatment of low back pain (Kreiner, 2020). Although nonpharmacologic therapies are addressed in this guideline, the specific role of biofeedback for low back pain is not addressed.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Campo et al published a systematic review and meta-analysis that evaluated the effectiveness of biofeedback for improving pain, disability, and work ability in adults with neck pain (Campo, 2021). The review included 15 RCTs with 8 studies utilizing EMG biofeedback and 7 studies pressure biofeedback. There was no restriction on the control intervention (eg, no treatment, placebo, active treatment) or co-intervention, provided the independent effects of biofeedback could be elucidated. Results suggest that biofeedback has a moderate effect on reducing short-term disability and a small effect on reducing intermediate-term disability with no effect on pain or work ability in the short- and intermediate-term. Of note, there were a variety of control interventions across included studies (eg, exercise, electroacupuncture, electrotherapy, education) with few studies directly comparing biofeedback to no treatment or placebo.
 
Kamonseki et al completed a systematic review and meta-analysis of 5 RCTs that examined the effects of EMG biofeedback for shoulder pain and function (Kamonseki, 2021). Overall, the evidence did not support the use of EMG biofeedback for reducing shoulder pain and improving shoulder function.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through March 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Karaborklu Argut et al conducted a systematic review of 8 RCTs of patients who had undergone orthopedic knee surgery (Karaborklu Argut, 2022). Therapeutic EMG biofeedback during rehabilitation was more effective for improving muscle strength and activation compared to home exercise, standard rehabilitation, or electrical stimulation. There were no clear trends in the effect of EMG biofeedback on pain or knee range of motion.
 
de Oliveira et al conducted an RCT in 24 patients with subacromial pain syndrome who received exercise or exercise plus EMG biofeedback for 8 weeks (de Oliveira, 2022). The primary outcomes were pain and shoulder function. At 8 weeks, pain was better in the exercise-only group (mean numeric pain rating, 0.5 vs 2 with exercise plus biofeedback; p=.01); however, this outcome was not different between groups at other time points. The only other significant finding was forward rotation of the scapula, which was better in the biofeedback group at 12 weeks (p=.006). All other outcomes were similar between groups.
 
In 2022, the U.S. Department of Veterans Affairs and U.S. Department of Defense updated their guideline on the diagnosis and treatment of low back pain (VA/DoD Clinical Practice Guideline, 2022). The guideline recommends several nonpharmacologic therapies for chronic low back pain (e.g., cognitive-behavioral therapy [CBT] and/or mindfulness-based stress reduction, progressive relaxation, exercise including yoga, pilates, and tai chi) but does not address the role of biofeedback.
CPT/HCPCS:
90875Individual psychophysiological therapy incorporating biofeedback training by any modality (face to face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 30 minutes
90876Individual psychophysiological therapy incorporating biofeedback training by any modality (face to face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 45 minutes
90901Biofeedback training by any modality
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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