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.

For individuals who have chronic pain (including low back, knee, neck and shoulder, orofacial, and abdominal pain as well as fibromyalgia, osteoarthritis, systemic lupus erythematosus, and vulvar vestibulitis) who receive biofeedback, the evidence includes multiple randomized controlled trials (RCTs) for different pain syndromes. The relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The results of these RCTs, some of which were sham-controlled, did not consistently report a benefit for biofeedback. Some RCTs reported improved outcomes with biofeedback, but these improvements were often of uncertain clinical significance or were not durable. Many other RCTs have found that biofeedback did not provide a significantly greater benefit in outcomes when it was used instead of or in addition to other conservative interventions such as exercise. Overall, the available RCTs were limited by small sample sizes and high dropout rates. This evidence base does not permit conclusions about the specific effects of biofeedback beyond the nonspecific effects of sham interventions, nor does it permit conclusions about the contribution of biofeedback beyond that of other conservative treatments for pain. The evidence is insufficient to determine the effects of the technology on health outcomes.   

Background
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.

Electroencephalographic biofeedback, also called neurofeedback, which measures brainwave activity, is addressed in evidence review 2.01.28. Evidence pertaining to the use of biofeedback for chronic insomnia is addressed in evidence review 2.01.28. Evidence pertaining to the use of biofeedback for miscellaneous indications (treatment of hypertension, anxiety, asthma, movement disorders [e.g., motor function after stroke, injury, or lower-limb surgery], and other applications) is addressed in evidence review 2.01.53. Evidence pertaining to the use of biofeedback for headache is addressed in evidence review 2.01.29. Evidence pertaining to the use of biofeedback for urinary incontinence is addressed in evidence review 2.01.27. Evidence pertaining to the use of biofeedback for fecal incontinence or constipation is addressed in evidence review 2.01.64.

Regulatory Status
Since 1976, a large number of biofeedback devices have been cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process. Food and Drug Administration product code: HCC.

Related Policies
20127 Biofeedback as a Treatment of Urinary Incontinence in Adults
20128 Neurofeedback
20129 Biofeedback as a Treatment of Headache
20153 Biofeedback for Miscellaneous Indications
20164 Biofeedback as a Treatment of Fecal Incontinence or Constipation

Policy:
Biofeedback as a treatment of chronic pain, including, but not limited to, low back pain, is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.  

Benefit Application
BlueCard/National Account Issues
In many Plans, biofeedback is contractually excluded. If contractually excluded in the host Plan, but not in the home Plan, the host Plan may use this policy as the basis of coverage decisions for the home Plan.

Biofeedback may be offered as part of a comprehensive program in pain management as offered by pain management centers.

Rationale
The evidence review was created in April 1998 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through September 9, 2022.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Psychological treatments involve both nonspecific and specific therapeutic effects. Nonspecific effects (sometimes called placebo effects) occur as a result of contact with the therapist, positive expectations on the part of the patient and therapist, and other beneficial effects that occur as a result of the patient being in a therapeutic environment. Specific effects are those that occur only because of the active treatment, beyond any nonspecific effects that may be present. This literature review focuses on identifying evidence that the effects of biofeedback are distinct from nonspecific placebo effects. Because establishing an ideal placebo control is problematic with psychological treatments and because treatment of chronic pain is typically multimodal, isolating the specific contribution of biofeedback is challenging.

Biofeedback
Clinical Context and Therapy Purpose
The purpose of electromyography (EMG) biofeedback in patients who have chronic pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does the use of EMG biofeedback improve the net health outcome in those who suffer from chronic pain?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with chronic pain, including low back, knee, neck and shoulder, orofacial, and abdominal pain as well as fibromyalgia, osteoarthritis, systemic lupus erythematosus, and vulvar vestibulitis.

Interventions
The therapy being considered is EMG biofeedback.

Comparators
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.¹ A multimodal approach to pain management consists of using treatments (i.e., 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.

Outcomes
The general outcomes of interest are reductions in symptoms and medication usage and improvements in functional outcomes.

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.² Table 1 summarizes provisional benchmarks for interpreting changes in chronic pain clinical trial outcome measures per IMMPACT.³

Table 1. Benchmarks for Interpreting Changes in Chronic Pain Outcome Measures 

Study Selection Criteria
Methodologically credible studies were selected using the following principles:  

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
General Chronic Pain
Several meta-analyses have reviewed RCTs assessing psychological therapies for a variety of nonheadache chronic pain conditions. A Cochrane review by Williams et al. (2020) focused on chronic pain in adults.⁴ Two RCTs were identified that compared behavioral therapy with an active control designed to change behavior (i.e., 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. (2018) focused on children and adolescents with chronic and recurrent pain.⁵ Although psychological therapies were found to improve pain, only 1 study evaluated biofeedback in nonheadache pain. Biofeedback did not improve abdominal pain more than cognitive-behavioral therapy (CBT) in this trial ⁶; see the section on Abdominal Pain). Palermo et al. (2010) published a meta-analysis of studies on psychological therapies for the management of chronic pain in children and adolescents.⁷ These authors did not identify any additional RCTs on biofeedback for managing nonheadache pain.

Low Back Pain
Systematic Reviews
A Cochrane review by Henschke et al. (2010) assessed behavioral treatments for chronic low back pain and conducted a meta-analysis of 3 small randomized trials that compared EMG biofeedback with a waiting-list control group.⁸ In the pooled analysis, there were a total of 34 patients in the intervention group and 30 patients in the control group. The standardized mean difference (SMD) 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. Reviewers did not conduct meta-analyses of trials comparing biofeedback with sham biofeedback and therefore were unable to control for any nonspecific effects of treatment.

Randomized Controlled Trials
At least 1 RCT has compared biofeedback with a sham intervention for the treatment of low back pain. Kapitza et al. (2010) compared the efficacy of respiratory biofeedback with sham biofeedback in 42 patients with low back pain.⁹ Both groups showed a reduction in pain levels on a 10-point visual analog scale (VAS) at the end of the intervention period and at 3-month follow-up. Between-group differences were not statistically significant. For example, 3 months after the intervention, mean change in pain with activity decreased by 1.12 points in the intervention group and 0.96 points in the sham control group (p > .05); mean change in pain at rest decreased by 0.79 points in the intervention group and 0.49 points in the control group (p > .05).

Several trials with active comparison groups have not found that biofeedback is superior to alternative treatments. More recently, Tan et al. (2015) evaluated 3 self-hypnosis interventions and included EMG biofeedback as a control intervention.¹⁰ This RCT enrolled 100 patients with chronic low back pain. After the 8-week intervention, reported reductions in pain intensity were significantly higher in the combined hypnosis groups than in the biofeedback group (p = .042).

A trial published by Glombiewski et al. (2010) assessed whether the addition of EMG biofeedback to CBT improved outcomes in 128 patients with low back pain.¹¹ Patients were randomized to 1 of 3 groups: CBT, CBT plus biofeedback, or waiting-list control. Both treatments improved outcomes including pain intensity compared with the 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.

Chronic Knee Pain
Collins et al. (2012) conducted a systematic review and meta-analysis of RCTs on nonsurgical interventions for anterior knee pain.¹² In a pooled analysis of data from 2 trials, there was no significant benefit of adding EMG biofeedback to an exercise-only intervention at 8 to 12 weeks (SMD, -0.22; 95% CI, -0.65 to 0.20).

Chronic Neck and Shoulder Pain
Systematic Reviews
Campo et al. (2021) 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.¹³ The review included 15 RCTs with 8 studies utilizing EMG biofeedback and 7 studies pressure biofeedback. There was no restriction on the control intervention (e.g., no treatment, placebo, active treatment) or co-intervention, provided the independent effects of biofeedback could be elucidated. An overview of the characteristics and results is presented in Tables 3 and 4. 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 (e.g., exercise, electroacupuncture, electrotherapy, education) with few studies directly comparing biofeedback to no treatment or placebo.

Kamonseki et al. (2021) completed a systematic review and meta-analysis of 5 RCTs that examined the effects of EMG biofeedback for shoulder pain and function.¹⁴ Study characteristics and results are presented in Tables 3 and 4. Overall, the evidence did not support the use of EMG biofeedback for reducing shoulder pain and improving shoulder function.

Table 2. Comparison of Studies Included in Systematic Reviews and Meta-Analyses 

Table 3. Systematic Review and Meta-Analysis Characteristics 

EMG: electromyography; RCT: randomized controlled trial.

Table 4. Systematic Review and Meta-Analysis Results 

CI: confidence interval; RCT: randomized controlled trial; SMC: standardized mean change; SMD: standardized mean difference.
^a High certainty: we are very confident that the true effect lies close to that of the estimate of the effect; moderate certainty: we are moderately confident in the effect estimate.; low certainty: our confidence in the effect estimate is limited; very low certainty: we have very little confidence in the effect estimate.

Ribeiro and Silva (2019) published a RCT assessing whether visual feedback improves range of motion in patients with chronic idiopathic neck pain.³² 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). There was no effect of time and intervention on pain intensity (p = .729) , but there was a significant interaction between time and intervention in neck flexion (p < .001). The study was limited by its small sample size, short duration of intervention, and by the researcher assessing patients not being blinded.

Orofacial Pain
A Cochrane review by Aggarwal et al. (2011) identified 17 trials evaluating nonpharmacologic psychological interventions for adults with chronic orofacial pain (e.g., temporomandibular joint disorder).³³ For studies reporting on short-term pain relief (≤ 3 months), a significantly greater reduction in pain was found for interventions that combined CBT plus biofeedback compared with usual care (2 studies; SMD, 0.46; 95% CI, 0.02 to 0.90). However, when reviewers assessed results from studies reporting on long-term pain relief (≥ 6 months), no significant benefit was found with a combined intervention of CBT plus biofeedback, and there were no studies that compared CBT alone with CBT plus biofeedback. For studies reporting on biofeedback-only interventions, a pooled analysis of 2 studies on short-term pain relief did not find a significant benefit compared with usual care (SMD, -0.41; 95% CI, -1.06 to 0.25). Only 1 study reported long-term pain relief after a biofeedback-only intervention, so a pooled analysis could not be done. Reviewers concluded that there was weak evidence to support psychosocial interventions for managing chronic orofacial pain and the most promising evidence was for CBT, with or without biofeedback. The authors noted that the trials comprising the review were few in number and had a high-risk of bias.

The conclusions drawn from this Cochrane review are similar to those of earlier systematic reviews on the treatment of temporomandibular joint disorder.^34,35 These older reviews also concluded that there was weak evidence that psychosocial/physical therapy interventions (including biofeedback) are beneficial for treating temporomandibular joint disorder and that, of the few studies available, they tended to be of poor methodologic quality.

Abdominal Pain
Systematic Reviews
In a systematic review of therapies for recurrent abdominal pain in children by Weydert et al. (2003), the behavioral interventions of CBT and biofeedback had a generally positive effect on nonspecific recurrent abdominal pain and were deemed safe.³⁶ The specific effects of biofeedback were not isolated in this systematic review and therefore cannot be assessed.

Randomized Controlled Trials
In a study by Humphreys and Gevirtz (2000), 64 children and teenagers diagnosed with recurrent abdominal pain were randomized to groups treated with increased dietary fiber; fiber and biofeedback; fiber, biofeedback, and CBT; or fiber, biofeedback, CBT, and parental support.⁶ The similar nature of the 3 multicomponent treatment groups was associated with greater pain reduction than the fiber-only group. This trial did not address placebo effects.

Fibromyalgia
Systematic Reviews
Glombiewski et al. (2013) published a systemic review and meta-analysis of RCTs reporting data on the efficacy of EMG and electroencephalography (EEG) biofeedback (i.e., neurofeedback) for treating patients with fibromyalgia.³⁷ Reviewers identified 7 RCTs that compared biofeedback with a control method in patients with fibromyalgia. Studies in which biofeedback was evaluated only as part of multicomponent interventions were excluded. Three studies used EEG biofeedback and 4 used EMG biofeedback (N = 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, a significant reduction in pain intensity was found compared with a different 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 in pain reduction compared with control methods. Pooled analyses of studies of EMG and EEG biofeedback did not find a significant benefit of either intervention on other outcomes such as sleep problems, depression, and health-related quality of life. None of the studies reviewed were of high quality, with the risk of bias assessed as unclear or high for all included studies. In addition, all studies reported short-term outcomes, resulting in a lack of evidence on whether longer-term outcomes improved with these interventions. (For more information on EEG biofeedback, see evidence review 2.01.28.)

Randomized Controlled Trials
In a small, double-blind RCT from Asia, Babu et al. (2007) compared actual and sham biofeedback for effects on pain, fitness, function, and tender points in 30 patients with fibromyalgia.³⁸ Pain reduction, as assessed on a VAS, did not differ significantly between groups. The trialists calculated that a sample size of 15 patients could detect a difference of 5 cm (on a 10-cm scale) on a VAS, suggesting that the trial lacked adequate power.

A larger unblinded RCT by van Santen et al. (2002) evaluated 143 women with fibromyalgia, and compared EMG biofeedback with fitness training and usual care.³⁹ The primary outcome was pain measured on a VAS. Compared with usual care, the investigators reported no clear improvements in objective or subjective patient outcomes with biofeedback (or fitness training).

Another RCT on EMG biofeedback for fibromyalgia was conducted by Buckelew et al. (1998), and enrolled 119 patients; however, the trial did not follow a double-blind design.⁴⁰ Patients were randomized to 1 of 4 treatment groups: (1) biofeedback/relaxation training, (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 trial did not address placebo effects or the impact of adding biofeedback to relaxation therapy.

Osteoarthritis
A systematic review by Macfarlane et al. (2012) evaluated practitioner-based complementary and alternative medicine treatments (defined as any treatment not taken orally or applied topically) for osteoarthritis and identified 2 trials on biofeedback.⁴¹ One was a RCT by Yilmaz et al. (2010) that assessed whether the addition of EMG biofeedback to strengthening exercises improved outcomes in 40 patients with knee osteoarthritis.⁴² After a 3-week treatment period, no significant differences between the 2 treatments regarding pain or quality of life were found. The other RCT, by Durmus et al. (2007), compared electrical stimulation with biofeedback-assisted exercise in 50 women with knee osteoarthritis.⁴³ After 4 weeks of treatment, there were no statistically significant differences between groups in pain and functioning scores.

Systemic Lupus Erythematosus
In a RCT by Greco et al. (2004), of 92 patients with systemic lupus erythematosus, those treated with 6 sessions of biofeedback-assisted CBT for stress reduction had statistically greater reductions in pain posttreatment than a symptom-monitoring support group (p = .044) and a group receiving usual care (p = .028).⁴⁴ However, these reductions in pain were not sustained at a 9-month follow-up.

Vulvar Vestibulitis
A randomized study by Bergeron et al. (2001) of 78 patients with dyspareunia resulting from vulvar vestibulitis compared treatment with EMG biofeedback, surgery, or CBT.⁴⁵ Patients who underwent surgery had significantly lower pain scores than patients who received biofeedback or CBT. No placebo treatment was used.

Summary of Evidence
For individuals who have chronic pain (including low back, knee, neck, and shoulder, orofacial, and abdominal pain as well as fibromyalgia, osteoarthritis, systemic lupus erythematosus, and vulvar vestibulitis) who receive biofeedback, the evidence includes multiple RCTs for different pain syndromes. Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. The results of these RCTs, some of which were sham-controlled, did not consistently report a benefit for biofeedback. Some RCTs reported improved outcomes with biofeedback, but these improvements were often of uncertain clinical significance or were not durable. Many other RCTs have found that biofeedback did not provide a significantly greater benefit in outcomes when it was used instead of or in addition to other conservative interventions such as exercise. Overall, the available RCTs were limited by small sample sizes and high dropout rates. This evidence base does not permit conclusions about the specific effects of biofeedback beyond the nonspecific effects of sham interventions, nor does it permit conclusions about the contribution of biofeedback beyond that of other conservative treatments for pain. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American College of Physicians
In 2017, the American College of Physicians issued practice guidelines on noninvasive treatments for acute, subacute, and chronic low back pain.⁴⁶ For patients with chronic low back pain, the guidelines recommended that initial treatment should be nonpharmacologic, such as "exercise, multidisciplinary rehabilitation, acupuncture, mindfulness-based stress reduction, tai chi, yoga, motor control exercise, progressive relaxation, electromyography biofeedback, low-level laser therapy, operant therapy, cognitive behavior therapy or spinal manipulation" (strong recommendation).

American College of Occupational and Environmental Medicine
In 2020, the American College of Occupational and Environmental Medicine updated their guideline on noninvasive and minimally invasive management of low back disorders.⁴⁷ The role of biofeedback is not addressed in this updated guideline.

American Society of Anesthesiologists & American Society of Regional Anesthesia and Pain Medicine
In 2010, the practice guidelines from the American Society of Anesthesiologists and the American Society of Regional Anesthesia and Pain Medicine suggested that "cognitive behavioral therapy, biofeedback, or relaxation training ... may be used as part of a multimodal strategy for patients with low back pain, as well as for other chronic pain conditions."⁴⁸

U.S. Department of Veterans Affairs and U.S. Department of Defense
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.⁴⁹ The guideline recommends several nonpharmacologic therapies for chronic low back pain (e.g., CBT and/or mindfulness-based stress reduction, progressive relaxation, exercise including yoga, pilates, and tai chi) but does not address the role of biofeedback.

North American Spine Society
In 2020, the North American Spine Society published a guideline for the diagnosis and treatment of low back pain.⁵⁰ Although nonpharmacologic therapies are addressed in this guideline, the specific role of biofeedback for low back pain is not addressed.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Current ongoing and unpublished clinical trials that might influence this review are listed in Table 5. 

Table 5. Summary of Key Trials

NCT: national clinical trial.

References  

1. U.S. Department of Health and Human Services. Pain management best practices. May 2019. https://www.hhs.gov/sites/default/files/pain-mgmt-best-practices-draft-final-report-05062019.pdf. Accessed September 21, 2022.
2. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. Jan 2005; 113(1-2): 9-19. PMID 15621359
3. Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. Feb 2008; 9(2): 105-21. PMID 18055266
4. Williams ACC, Fisher E, Hearn L, et al. Psychological therapies for the management of chronic pain (excluding headache) in adults. Cochrane Database Syst Rev. Aug 12 2020; 8: CD007407. PMID 32794606
5. Fisher E, Law E, Dudeney J, et al. Psychological therapies for the management of chronic and recurrent pain in children and adolescents. Cochrane Database Syst Rev. Sep 29 2018; 9: CD003968. PMID 30270423
6. Humphreys PA, Gevirtz RN. Treatment of recurrent abdominal pain: components analysis of four treatment protocols. J Pediatr Gastroenterol Nutr. Jul 2000; 31(1): 47-51. PMID 10896070
7. Palermo TM, Eccleston C, Lewandowski AS, et al. Randomized controlled trials of psychological therapies for management of chronic pain in children and adolescents: an updated meta-analytic review. Pain. Mar 2010; 148(3): 387-397. PMID 19910118
8. Henschke N, Ostelo RW, van Tulder MW, et al. Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev. Jul 07 2010; (7): CD002014. PMID 20614428
9. Kapitza KP, Passie T, Bernateck M, et al. First non-contingent respiratory biofeedback placebo versus contingent biofeedback in patients with chronic low back pain: a randomized, controlled, double-blind trial. Appl Psychophysiol Biofeedback. Sep 2010; 35(3): 207-17. PMID 20237953
10. Tan G, Rintala DH, Jensen MP, et al. A randomized controlled trial of hypnosis compared with biofeedback for adults with chronic low back pain. Eur J Pain. Feb 2015; 19(2): 271-80. PMID 24934738
11. Glombiewski JA, Hartwich-Tersek J, Rief W. Two psychological interventions are effective in severely disabled, chronic back pain patients: a randomised controlled trial. Int J Behav Med. Jun 2010; 17(2): 97-107. PMID 19967572
12. Karaborklu Argut S, Celik D, Yasaci Z. Effectiveness of therapeutic electromyographic biofeedback after orthopedic knee surgeries: a systematic review. Disabil Rehabil. Jul 2022; 44(14): 3364-3372. PMID 33417500
13. Collins NJ, Bisset LM, Crossley KM, et al. Efficacy of nonsurgical interventions for anterior knee pain: systematic review and meta-analysis of randomized trials. Sports Med. Jan 01 2012; 42(1): 31-49. PMID 22149696
14. Campo M, Zadro JR, Pappas E, et al. The effectiveness of biofeedback for improving pain, disability and work ability in adults with neck pain: A systematic review and meta-analysis. Musculoskelet Sci Pract. Apr 2021; 52: 102317. PMID 33461043
15. Kamonseki DH, Calixtre LB, Barreto RPG, et al. Effects of electromyographic biofeedback interventions for shoulder pain and function: Systematic review and meta-analysis. Clin Rehabil. Jul 2021; 35(7): 952-963. PMID 33517777
16. Juul-Kristensen B, Larsen CM, Eshoj H, et al. Positive effects of neuromuscular shoulder exercises with or without EMG-biofeedback, on pain and function in participants with subacromial pain syndrome - A randomised controlled trial. J Electromyogr Kinesiol. Oct 2019; 48: 161-168. PMID 31394380
17. Kosterink SM, Huis in 't Veld RM, Cagnie B, et al. The clinical effectiveness of a myofeedback-based teletreatment service in patients with non-specific neck and shoulder pain: a randomized controlled trial. J Telemed Telecare. 2010; 16(6): 316-21. PMID 20798425
18. Ma C, Szeto GP, Yan T, et al. Comparing biofeedback with active exercise and passive treatment for the management of work-related neck and shoulder pain: a randomized controlled trial. Arch Phys Med Rehabil. Jun 2011; 92(6): 849-58. PMID 21621660
19. Middaugh S, Thomas KJ, Smith AR, et al. EMG Biofeedback and Exercise for Treatment of Cervical and Shoulder Pain in Individuals with a Spinal Cord Injury: A Pilot Study. Top Spinal Cord Inj Rehabil. 2013; 19(4): 311-23. PMID 24244096
20. Sandsjo L, Larsman P, Huis in 't Veld RM, et al. Clinical evaluation of a myofeedback-based teletreatment service applied in the workplace: a randomized controlled trial. J Telemed Telecare. 2010; 16(6): 329-35. PMID 20798427
21. Arami J, Rezasoltani A, Khalkhali Z, et al. The effect of two exercise therapy programs (proprioceptive and endurance training) to treat patients with chronic non-specific neck pain. JBUMS. 2012;14(1):77-84.
22. Bissett A, Mitchell KR, Major G. The cervico-brachial pain syndrome: muscle activity and pain relief. Behav Change. 1985;2(2):129-132.
23. Bobos P, Billis E, Papanikolaou DT, et al. Does Deep Cervical Flexor Muscle Training Affect Pain Pressure Thresholds of Myofascial Trigger Points in Patients with Chronic Neck Pain? A Prospective Randomized Controlled Trial. Rehabil Res Pract. 2016; 2016: 6480826. PMID 27990302
24. Dellve L, Ahlstrom L, Jonsson A, et al. Myofeedback training and intensive muscular strength training to decrease pain and improve work ability among female workers on long-term sick leave with neck pain: a randomized controlled trial. Int Arch Occup Environ Health. Mar 2011; 84(3): 335-46. PMID 20803028
25. Ehrenborg C, Archenholtz B. Is surface EMG biofeedback an effective training method for persons with neck and shoulder complaints after whiplash-associated disorders concerning activities of daily living and pain -- a randomized controlled trial. Clin Rehabil. Aug 2010; 24(8): 715-26. PMID 20562165
26. Eslamian F, Jahanjoo F, Dolatkhah N, et al. Relative Effectiveness of Electroacupuncture and Biofeedback in the Treatment of Neck and Upper Back Myofascial Pain: A Randomized Clinical Trial. Arch Phys Med Rehabil. May 2020; 101(5): 770-780. PMID 31954696
27. Iqbal ZA, Rajan R, Khan SA, et al. Effect of deep cervical flexor muscles training using pressure biofeedback on pain and disability of school teachers with neck pain. J Phys Ther Sci. Jun 2013; 25(6): 657-61. PMID 24259822
28. Jull G, Trott P, Potter H, et al. A randomized controlled trial of exercise and manipulative therapy for cervicogenic headache. Spine (Phila Pa 1976). Sep 01 2002; 27(17): 1835-43; discussion 1843. PMID 12221344
29. Jull G, Falla D, Treleaven J, et al. Retraining cervical joint position sense: the effect of two exercise regimes. J Orthop Res. Mar 2007; 25(3): 404-12. PMID 17143898
30. Nezamuddin M, Answer S, Khan SA, et al. Efficacy of pressure-biofeedback guided deep cervical flexor training on neck pain and muscle performance in visual display terminal operators. J Musculoskelet Res. 2013;16(3):1350011
31. Voerman GE, Sandsjo L, Vollenbroek-Hutten MM, et al. Effects of ambulant myofeedback training and ergonomic counselling in female computer workers with work-related neck-shoulder complaints: a randomized controlled trial. J Occup Rehabil. Mar 2007; 17(1): 137-52. PMID 17260162
32. Wani S, Raka N, Jethwa J, et al. Comparative efficacy of cervical retraction exercises (McKenzie) with and without using pressure biofeedback in cervical spondylosis. Int J Ther Rehabil. 2013;20(10):501-508.
33. de Oliveira AKA, da Costa KSA, de Lucena GL, et al. Comparing exercises with and without electromyographic biofeedback in subacromial pain syndrome: A randomized controlled trial. Clin Biomech (Bristol, Avon). Mar 2022; 93: 105596. PMID 35183878
34. Ribeiro D, Silva AG. A single session of visual feedback improves range of motion in patients with chronic idiopathic neck pain: A randomized and controlled study. Musculoskeletal Care. Mar 2019; 17(1): 72-78. PMID 30378756
35. Aggarwal VR, Lovell K, Peters S, et al. Psychosocial interventions for the management of chronic orofacial pain. Cochrane Database Syst Rev. Nov 09 2011; (11): CD008456. PMID 22071849
36. McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. May 2006; 86(5): 710-25. PMID 16649894
37. Medlicott 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. Jul 2006; 86(7): 955-73. PMID 16813476
38. Weydert JA, Ball TM, Davis MF. Systematic review of treatments for recurrent abdominal pain. Pediatrics. Jan 2003; 111(1): e1-11. PMID 12509588
39. Glombiewski JA, Bernardy K, Hauser W. Efficacy of EMG- and EEG-Biofeedback in Fibromyalgia Syndrome: A Meta-Analysis and a Systematic Review of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2013; 2013: 962741. PMID 24082911
40. Babu AS, Mathew E, Danda D, et al. Management of patients with fibromyalgia using biofeedback: a randomized control trial. Indian J Med Sci. Aug 2007; 61(8): 455-61. PMID 17679735
41. 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. Mar 2002; 29(3): 575-81. PMID 11908576
42. Buckelew SP, Conway R, Parker J, et al. Biofeedback/relaxation training and exercise interventions for fibromyalgia: a prospective trial. Arthritis Care Res. Jun 1998; 11(3): 196-209. PMID 9782811
43. Macfarlane GJ, Paudyal P, Doherty M, et al. A systematic review of evidence for the effectiveness of practitioner-based complementary and alternative therapies in the management of rheumatic diseases: osteoarthritis. Rheumatology (Oxford). Dec 2012; 51(12): 2224-33. PMID 22923762
44. Yilmaz OO, Senocak O, Sahin E, et al. Efficacy of EMG-biofeedback in knee osteoarthritis. Rheumatol Int. May 2010; 30(7): 887-92. PMID 19693508
45. Durmus D, Alayli G, Canturk F. Effects of quadriceps electrical stimulation program on clinical parameters in the patients with knee osteoarthritis. Clin Rheumatol. May 2007; 26(5): 674-8. PMID 16897119
46. 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. Aug 15 2004; 51(4): 625-34. PMID 15334437
47. 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. Apr 2001; 91(3): 297-306. PMID 11275387
48. Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. Apr 04 2017; 166(7): 514-530. PMID 28192789
49. Hegmann KT, Travis R, Andersson GBJ, et al. Non-Invasive and Minimally Invasive Management of Low Back Disorders. J Occup Environ Med. Mar 2020; 62(3): e111-e138. PMID 31977923
50. Benzon HT, Connis RT, De Leon-Casasola OA, et al. Practice guidelines for chronic pain management: an updated report by the American Society of Anesthesiologists Task Force on Chronic Pain Management and the American Society of Regional Anesthesia and Pain Medicine. Anesthesiology. Apr 2010; 112(4): 810-33. PMID 20124882
51. VA/DoD Clinical Practice Guideline. (2022). The Diagnosis and Treatment of Low Back Pain. Washington, DC: U.S. Government Printing Office. Version 3.0. https://www.healthquality.va.gov/guidelines/Pain/lbp/VADoDLBPCPGFinal508.pdf. Accessed September 21, 2022.
52. Kreiner DS, Matz P, Bono CM, et al. Guideline summary review: an evidence-based clinical guideline for the diagnosis and treatment of low back pain. Spine J. Jul 2020; 20(7): 998-1024. PMID 32333996
53. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Biofeedback Therapy (30.1). n.d.; https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=41&ncdver=1&bc=AAAAQAAAAAAA&. Accessed September 21, 2022.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2014 Forward