| Coverage Policy Manual | |
| Policy #: | 1998043 |
| Category: | Medicine |
| Initiated: | August 2017 |
| Last Review: | August 2023 |
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| Biofeedback for Miscellaneous Indications | |
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| 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 has been proposed as a treatment for a variety of diseases and disorders including anxiety, headache (migraine and tension), hypertension, incontinence (fecal and urinary), and movement disorders.
The type of feedback used in an intervention depends on the nature of the disease or disorder under treatment. For hypertension, blood pressure is monitored and the data reported back to the patients. For tension headaches, electromyographic (EMG) measurement of muscular contraction is used. For migraine headaches, EMG measuring contraction of the frontalis muscle and skin temperature feedback data are used. For fecal and urinary incontinence, EMG data are used. Data from manometric studies may also be used in biofeedback for fecal incontinence.
The application of biofeedback to the treatment of urinary and rectal incontinence differs somewhat from the general tenets of biofeedback in that the biofeedback is used to help the patient learn to control and coordinate the contraction of sphincter muscles, i.e.., skeletal muscles, which are under voluntary control. In particular, biofeedback as a treatment for urinary incontinence is often used to enhance training in pelvic floor muscle exercises (PME).
This policy focuses on the use of biofeedback for the treatment of hypertension, anxiety, insomnia, asthma, movement disorders, and other miscellaneous applications. Policies that handle biofeedback for other various specific indications include:
2009025 Biofeedback as a Treatment of Urinary Incontinence
2009026 Biofeedback as a Treatment of Headache
2009027 Biofeedback as a Treatment of Chronic Pain
2009028 Biofeedback as a Treatment of Fecal Incontinence
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Policy/ Coverage: |
Effective August 2021
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Biofeedback for any condition is an exclusion in the member certificate of coverage of most member benefit certificates.
For members with benefit certificates without this specific contract exclusion, biofeedback does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes for any indication, including but not limited to, the treatment of the following indications:
For members with contracts without primary coverage criteria whose contract does not include this specific contract exclusion, biofeedback for any indication is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to August 2021
Biofeedback for any condition is an exclusion in the member certificate of coverage in most member benefit certificates.
For member benefit certificates without this specific contract exclusion, biofeedback does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes a treatment of the following indications:
For member benefit certificates without this specific contract exclusion, with contracts without primary coverage criteria biofeedback for the above indications is investigational.
Effective August 2014
Biofeedback for any condition is an exclusion in the member certificate of coverage in most member benefit certificates.
For member benefit certificates without this specific contract exclusion, biofeedback does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes a treatment of the following indications:
For member benefit certificates without this specific contract exclusion, with contracts without primary coverage criteria biofeedback for the above indications is investigational.
Effective August 2011
Biofeedback for any condition is an exclusion in the member certificate of coverage in most member benefit certificates.
For member benefit certificates without this specific contract exclusion, biofeedback is considered investigational as a treatment of the following indications:
Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to August 2011
Biofeedback for any condition is an exclusion in the member certificate of coverage in most member benefit certificates.
For member benefit certificates without this specific contract exclusion, biofeedback is considered investigational as a treatment of anxiety disorders, hypertension, insomnia, movement disorders, asthma, and Raynaud’s disease. Investigational services are not a covered benefit.
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| Rationale: |
This policy was originally developed in 1998. It is being updated with a literature search through June 2011. Following is a summary of literature on biofeedback for miscellaneous conditions not considered in other policies.
Hypertension
A systematic review of studies on biofeedback for hypertension was published by Greenhalgh and colleagues in 2010 (Greenhalgh, 2010). The investigators searched for RCTs that included adults with essential hypertension (defined as at least 140/90 mm Hg) and that compared biofeedback interventions, alone or in combination with other therapies, to medication, sham biofeedback, no treatment, or another behavioral intervention. A total of 36 trials (n=1,660) met inclusion criteria. Trials generally had small sample sizes; only 4 included more than 100 patients. All were single-center, and most were conducted in the United States. Trials used a variety of biofeedback techniques including thermal biofeedback, galvanized skin response, pulse wave velocity, and heart rate variability; some trials used more than 1 modality. Twenty studies evaluated biofeedback alone, fifteen evaluated biofeedback combined with another intervention, and 1 had multiple arms and evaluated both types of interventions; only 4 trials included a sham biofeedback comparison group. The authors stated that they did not pool study findings due to differences in interventions and outcomes and the generally poor quality of the studies.
The investigators reported that trials comparing biofeedback alone versus no treatment or another behavioral intervention did not provide convincing evidence of the superiority of biofeedback. Only 1 of 5 trials that compared a biofeedback combination intervention (most commonly combined with relaxation) to a different behavioral treatment found the biofeedback intervention to be superior. Approximately half of the trials comparing a biofeedback combination to no treatment found a significant benefit to the biofeedback combination, but the specific effects of biofeedback cannot be determined from this analysis. Only 1 trial was identified that compared a biofeedback combination intervention to sham biofeedback, and this study did not find a significant difference in the efficacy of the 2 interventions. Four studies on biofeedback alone and another 4 on a combined biofeedback intervention reported data beyond 6 months; most of these found no significant differences in efficacy between the biofeedback and control groups. Greenhalgh and colleagues concluded, “…we found no convincing evidence that consistently demonstrates the effectiveness of the use of any particular biofeedback treatment in the control of essential hypertension when compared with pharmacotherapy, placebo, no intervention or other behavioral therapies.”
In a previous meta-analysis, published in 2003, Nakao and colleagues found that biofeedback was effective in lowering systolic and diastolic blood pressure but only when the biofeedback was combined with relaxation techniques (Nakao, 2003). The authors further noted that study is needed to determine whether biofeedback has any blood pressure lowering effect without relaxation techniques.
Motor function after stroke, injury, or lower-limb surgery
Several systematic reviews have been published; none of these conducted quantitative pooling of results due to heterogeneity among study populations, interventions, and outcome measures. A 2010 systematic review by Silkman and McKeon evaluated the effectiveness of electromyography (EMG) biofeedback for improving muscle function during knee rehabilitation after injury (Silkman, 2010). Four RCTs that compare knee rehabilitation exercise programs with and without biofeedback were identified. Sample sizes in individual studies ranged from 26 to 60 patients. Two of the 4 studies found a statistically significantly greater benefit in the programs that included biofeedback, and the other 2 did not find a significant difference between groups. The positive studies assessed intermediate outcomes e.g., contraction values of the quadriceps muscles. None of the studies were designed to assess functional outcomes.
A Cochrane review that assessed electromyographic (EMG) biofeedback for the recovery of motor function after stroke was published in 2007 (Woodford, 2007). It included 13 randomized or quasi-randomized studies with a total of 269 patients. All of the trials compared EMG biofeedback plus standard physiotherapy to standard physiotherapy; in addition to standard physiotherapy, several studies also included a sham biofeedback group. The studies tended to be small and poorly designed. The authors did not find support for EMG biofeedback to improve motor power, functional recovery, or gait quality when compared to physiotherapy alone.
A systematic review by Zijlstra and colleagues, published in 2010, searched for studies evaluating biofeedback-based training to improve mobility and balance in adults older than 60 years of age (Zijlstra, 2010). Although the review was not limited to studies on motor function after stroke, more than half of the studies included older adults post-stroke. For inclusion in this review, studies needed to include a control group of patients who did not receive biofeedback and to assess at least 1 objective outcome measure. A total of 97 potentially relevant articles were identified, and 21 (22%) studies, including 17 RCTs, met the selection criteria. Twelve of the 21 (57%) studies included individuals post-stroke, 3 included older adults who had lower-limb surgery, and 6 included frail older adults without a specific medical condition. Individual studies were small; sample sizes ranged from 5 to 30 patients. The added benefit of using biofeedback could be evaluated in 13 of 21 (62%) studies. Nine of the 13 studies found a significantly greater benefit with interventions that used biofeedback compared to control interventions. However, the outcomes assessed were generally not clinical outcomes but were laboratory-based measures related to executing a task, e.g., moving from sitting to standing in a laboratory setting and platform-based measures of postural sway. The applicability of improvements in these types of measures to clinical outcomes such as the ability to perform activities of daily living or the rate of falls, is unknown. Only 1 study cited in this review reported an improvement in fall rates, and this trial could not isolate the effect of biofeedback from other components of treatment. In addition, only 3 studies reported long-term outcomes, and none of these reported a significant effect of biofeedback. Conclusions about the efficacy of biofeedback for improving mobility and balance in older adults cannot be drawn from these data due to the lack of evidence on clinical outcomes. Other methodologic limitations include limited data on the durability of effects and the inability to isolate the effect of biofeedback in many studies.
A 2010 RCT, not included in the Zijlstra et al. review, evaluated biofeedback to improve motor function in patients who were at least 6 months post-stroke (Jonsdottir, 2010). The study, conducted in Italy by Jonsdottir and colleagues, randomized 20 patients to 20 sessions of EMG biofeedback (n=10) or standard rehabilitation (n=10). Patients in both groups received sessions lasting 45 minutes 3 times a week. The biofeedback consisted of an acoustic signal; patients in the intervention group wore a biofeedback belt device.
All patients completed the 20 sessions, and 9 in each group (a total of 90%) were available for the follow-up 6 weeks after completion of the intervention. The analyses found statistically significant effects of the biofeedback intervention on the outcome variables ankle power peak, velocity, and stride length but not knee flexion peak from baseline evaluation to the final follow-up. For example, in the treatment group, stride length (percent height per second) increased from 44.1 pre-treatment to 51.1 at final follow-up, and stride length in the control group increased from 33.4 pre-treatment to 35.2 at final follow-up. Although positive, data from this study alone cannot change the conclusion of an insufficient body of evidence on biofeedback to improve motor function after stroke. Moreover, the study did not evaluate outcomes related to activities of daily living, and the biofeedback protocol used in the study has not been replicated in other studies.
Raynaud’s disease
A 2009 systematic review on complementary and alternative medicine in the treatment of Raynaud’s disease included an examination of the literature on biofeedback (Malenfant, 2009). The authors identified 5 trials, and these reported a variety of outcomes. A pooled analysis of findings from 4 trials (total n=110) on the change in frequency of attacks favored the sham control group over the biofeedback group (weighted mean difference: -1.21; 95% confidence interval [CI]: -1.68 to -0.73; p<0.00001). Several trials had more than 2 arms; in the preceding analysis, only the arms comparing active and sham biofeedback were included.
The trial that was given the highest quality rating by the authors of the systematic review and had the largest sample size was the Raynaud’s Treatment Study, published in 2000 (Raynaud’s Treatment Study Investigatars, 2000). This was a randomized comparison of sustained-release nifedipine and thermal biofeedback in 313 patients with primary Raynaud’s disease. In addition to these 2 treatment groups, there were 2 control treatments: pill placebo and EMG biofeedback. EMG biofeedback was chosen as a control because it did not address the physiologic mechanism of Raynaud’s disease. The mean attack rate at 1 year, the primary study outcome, was 0.16 in the thermal biofeedback group, 0.23 in the EMG biofeedback group, 0.07 in the nifedipine group, and 0.21 in the placebo group. Nifedipine significantly reduced Raynaud’s attacks compared with placebo (p<0.002), but thermal feedback did not differ significantly from EMG biofeedback (0 37). There was not a significant difference in attack rates in the nifedipine and thermal biofeedback groups for the primary outcome (p=0.08). However, several secondary outcomes including all attacks and verified attacks at 2 months significantly favored nifedipine over thermal biofeedback.
Sleep bruxism
One small randomized study (n=57) examined changes in sleep bruxism following treatment with a cognitive behavioral therapy program consisting of problem-solving, progressive muscle relaxation, nocturnal biofeedback, and training of recreation and enjoyment (Ommerborn, 2007). Similar improvements were observed for the occlusal splint group as for the multicomponent cognitive behavioral program. The effects of biofeedback were not isolated in this study and thus conclusions cannot e drawn about its effectiveness compared to occlusal splinting.
Tinnitus
An RCT by Weise et al. investigated the efficacy of a biofeedback-based cognitive-behavioral treatment for tinnitus in Germany (Weise, 2008). Tinnitus patients (n=130) were randomly assigned to an intervention or a waiting-list control group. Treatment consisted of 12 sessions of a biofeedback-based behavioral intervention over a 3-month period. The primary outcome measures were global tinnitus annoyance and a daily rating of tinnitus disturbance measured by a Tinnitus Questionnaire (TQ) and a daily diary using visual analog scale (VAS) scores. Patients in the waiting-list group participated in the treatment after the intervention group had completed the treatment. Results showed improvements regarding the following: tinnitus annoyance; diary ratings of loudness; feelings of controllability; changes in coping cognitions; changes in depressive symptoms; TQ: total score (range 0–84) pre-assessment mean 54.7, post-assessment mean 32.52; TQ: emotional distress (range 0–24) pre-assessment mean 16.00, post-assessment mean 8.15; and diary: loudness VAS (range 0–10) pre-assessment mean 5.68, post-assessment mean 4.38. Improvements were maintained over a 6-month follow-up period in which variable effect sizes were observed. The study does not investigate the possible additive effect of biofeedback with cognitive-behavioral therapy and did not include an active treatment control group. In conclusion, these data are insufficient to draw clinical conclusions regarding the role of biofeedback for the treatment of tinnitus.
Bell's palsy
In 2008, Cardoso et al. published a systematic review of studies on the effects of facial exercises on symptoms of Bell's palsy (Cardoso, 2008). Studies including patients with unilateral idiopathic facial palsy treated with facial exercises associated with mirror and/or EMG biofeedback were included in this review. Four studies (n=132) met the eligibility criteria. The studies described mime therapy versus control (n=50), mirror biofeedback exercise versus control (n=27), "small" mirror movements versus conventional neuromuscular retraining (n=10), and EMG biofeedback plus mirror training versus mirror training alone. The treatment length varied from 1 to 12 months. The authors concluded that “…because of the small number of randomized controlled trials, it was not possible to analyze if the exercises, associated either with mirror or EMG biofeedback, were effective. In summary, the available evidence from randomized controlled trials is not yet strong enough to become integrated into clinical practice.”
Orthostatic hypotension in patients with a spinal cord injury
Gillis et al. conducted a systematic review to identify and describe the body of literature pertaining to nonpharmacologic management of orthostatic hypotension during the early rehabilitation of persons with a spinal cord injury (Gillis, 2008). Participants with any level or degree of completeness of spinal cord injury and any time elapsed since their injuries were included. Interventions must have measured at least systolic blood pressure and have induced orthostatic stress in a controlled manner and have attempted to control orthostatic hypotension during an orthostatic challenge. Four distinct nonpharmacologic interventions for orthostatic hypotension were identified: application of compression and pressure to the abdominal region and/or legs, upper body exercise, functional electrical stimulation applied to the legs, and biofeedback. Methodologic quality varied dramatically between studies. The authors concluded that ”…The clinical usefulness of compression/pressure, upper body exercise and biofeedback for treating OH [orthostatic hypotension] has not been proven.”
Autism
A 2010 article by Coben and Myers reviewed the literature on EEG biofeedback for autistic disorders (Coben, 2010). The authors identified 2 published non-randomized controlled studies evaluating EEG biofeedback in the treatment of autistic disorders. As described in the review, a study published by Jarusiewicz and colleagues in 2002 compared treatment with 20 to 69 sessions of biofeedback in 12 autistic children to a matched control group that did not receive biofeedback. Mean reduction in autistic symptoms, as measured by the Autism Treatment Evaluation Checklist (ATEC), was 26% in the biofeedback group and 3% in the comparison group; this difference was statistically significant. The other study was published by Coben and Padolsky in 2007. It compared 20 sessions of EEG biofeedback in 37 patients to a waiting-list control group. After treatment, parents reported reduction in symptoms in 89% of the treatment group compared to 17% of the control group (p-value not reported). Studies differed in their biofeedback protocols and number of sessions. The review article concluded that RCTs are needed to determine the effectiveness of biofeedback to treat autism.
Ongoing clinical trials
Improving function after knee arthroplasty with weight-bearing biofeedback (NCT001333189) : This randomized controlled trial is comparing a weight-bearing exercise program using biofeedback to a usual-care exercise program. The primary study outcome is weight-bearing symmetry 6 weeks post-surgery; secondary outcomes include the 6-minute walk test and stair climb test. The estimated date of study completion is December 2012.
2013 Update
A search of the MEDLINE database through 2013 did not reveal any new literature that would prompt a change in the coverage statement.
2014 Update
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Motor function after stroke
Numerous RCTs and several systematic reviews of RCTs have been published. Systematic reviews have noted that RCTs tended to have relatively small sample sizes and only small RCTs were identified in policy updates (Rayegani, 2014).
Prevention of preterm birth
One small RCT was identified. In 2014, Siepmann et al published data on 48 women who had experienced threatened preterm labor between the 24th and 32nd gestational week (Siepmann, 2014). Twenty-four patients received 6 biofeedback sessions over 2 weeks and the other 24 patients were in a usual care group. Preterm delivery occurred in 3 patients (13%) in the biofeedback group and 8 patients (33%) in the control group; the difference between groups was not statistically significant, p>0.05. Other gestational outcome data, such as the gestational duration and birthweight, also did not differ significantly between groups.
There is insufficient evidence that biofeedback is effective in preventing preterm birth in pregnant women with a history of threatened preterm labor.
2015 Update
A literature search conducted through July 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
Psychological 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. The literature review focuses on identifying evidence that isolates the specific effect of biofeedback, apart from the nonspecific placebo effects. Because 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 difficult. An ideal study design would be a randomized controlled trial (RCT) comparing biofeedback with a sham intervention; an alternative design would be an RCT comparing an intervention such as exercise with and without the addition of biofeedback.
Anxiety
In 2014, Canadian Agency for Drugs and Technology in Health (CADTH) published a rapid response report on biofeedback for treating mood and anxiety disorders (Ottawa, 2014). Their systematic review of the literature did not identify any health technology assessments systematic reviews, meta-analyses, RCTs, or nonrandomized studies evaluating biofeedback for the treatment of generalized anxiety disorder.
There is insufficient evidence from high-quality controlled studies that biofeedback improves outcomes in patients with anxiety disorder.
Depression
The 2014 CADTH report on biofeedback for mood and anxiety disorders, previously discussed (Ottawa, 2014) included a systematic review of the literature on biofeedback for depression. Other than 2 dissertations using heart-rate biofeedback, no health technology assessments systematic reviews, meta-analyses, RCTs or nonrandomized studies evaluating biofeedback for the treatment of depression were identified.
There is insufficient evidence from high-quality controlled studies that biofeedback improves outcomes in patients with depression.
Multiple Sclerosis
A 2015 RCT by MacKay and colleagues evaluated the addition of biofeedback to standard care in 40 patients with relapsing-remitting multiple sclerosis (MS) patients (MacKay, 2015). The standard care psychosocial intervention consisted of relaxation, mindfulness, social support, and education. All patients attended 1-hour training and assessment sessions at weekly intervals. During the first session, all patients had training in mindfulness breathing exercises and progressive muscle relaxation techniques. Patients randomized to the biofeedback arm received additional instruction on use of biofeedback equipment for self-regulation. Following the 3 weekly sessions, patients were instructed to practice the exercises at home, with or without use of biofeedback equipment. Outcomes included breathing rate and anxiety, depression, fatigue, and muscle tension measures. At the end of treatment, there were not statistically significant differences between groups in any outcomes. However, some variables were marginally significant. The difference between the intervention and control group in breathing rate was 3.06 (95% CI, -0.17 to 6.280; p=0.06) and the difference in muscle tension was -13.91 (95% CI, -30.06 to 2.25; p=0.09). Both groups had similar amounts of provider contact so nonspecific intervention effects were not a potential issue.
There is insufficient evidence that biofeedback improves MS symptoms. There was 1 small RCT that did not find statistically significant benefit of biofeedback added to standard care compared with standard care alone.
Posttraumatic Stress Disorder
The 2014 CADTH report on biofeedback for mood and anxiety disorders, previously discussed (Ottawa, 2014) included a systematic review of the literature on biofeedback for posttraumatic stress disorder (PTSD). One systematic review was identified; this study was published in 2014 by Wahbeh and colleagues and addressed a variety of complementary and alternative medicine approaches to treating PTSD (Wahbeh, 2014). Four of 33 studies that met selection criteria of the Wahbeh review addressed biofeedback. Among the biofeedback studies were 1 RCT, 1 RCTs that were not randomized, and 2 case series. The controlled trials either had mixed results or did not find a significant benefit of biofeedback.
There is insufficient evidence from controlled studies that biofeedback improves outcomes in patients with PTSD.
2018 Update
A literature search was conducted through July 2018. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
ANXIETY DISORDERS
Randomized Controlled Trials
Chen et al published an RCT comparing diaphragmatic breathing relaxation (DBR) with routine respiration activities in the treatment of 46 patients with anxiety (Chen, 2016). DBR is a technique that uses diaphragm muscle contractions to force air downward into the body, increasing diaphragm length and breathing efficiency. Outcomes were anxiety level, measured by Beck Anxiety Inventory, and 4 physiological measures (skin conductivity, peripheral blood flow, heart rate, breathing rate). All patients participated in an individualized 8-week course in breathing relaxation, but only 30 completed it. Fifteen were randomized to DBR training and 15 to routine breathing relaxation training. Researchers and patients were blinded to randomization, with only the trainer being aware of group allocation. After 8 weeks, the DBR group experienced statistically significant decreases in Beck Anxiety Inventory scores compared with baseline, while the control group did not experience significant decreases from baseline. The DBR group also experienced significant improvements in all 4 physiological measurements, while the control group did not.
HYPERTENSION
Randomized Controlled Trials
Wang et al published an RCT evaluating the effect of direct blood pressure biofeedback on patients with prehypertension or stage I hypertension (Wang, 2016). A trained nurse instructed patients in blood pressure self-regulation by using slow diaphragmatic breathing and passive attitude. During the 8-week training (1 session per week), patients in the treatment group received real-time blood pressure feedback signals (n=29) and controls received pseudo-feedback signals (n=28). Outcomes were systolic and diastolic blood pressure, measured at baseline and 1 and 8 weeks after training. Both groups significantly decreased blood pressure following training. The decreases were equal in magnitude, suggesting that blood pressure self-regulation training can effectively lower blood pressure, regardless of the type of feedback signal.
MOTOR DYSFUNCTION AFTER STROKE
Systematic Reviews
Stanton et al updated a systematic review and meta-analysis published in 2011 (see below) which evaluated the effect of biofeedback on lower-limb activities in patients who have had a stroke (Stanton, 2017). Only high-quality RCTs or quasi-RCTs with Physiotherapy Evidence Database (PEDro) scores greater than 4 were included. The literature search, conducted through September 2015, identified 18 trials (total N=429 patients) for inclusion. Training activities were walking (9 trials), standing (8 trials), and standing up (1 trial). Trials were small, with study populations ranging from 12 to 50 patients. Biofeedback techniques included weight distribution from a force platform or sensor (11 trials), muscle activity from EMG (3 trials), linear gait parameters (3 trials), and joint angle from a goniometer (1 trial). Visual feedback was used in 7 trials, auditory in 7 trials, and a combination of visual/auditory in 4 trials. Pooled standardized mean difference of the short-term effect of biofeedback from 17 trials (n=417) was significant (0.50; 95% confidence interval [CI], 0.3 to 0.7). Long-term effects could not be calculated because only 4 trials provided that information.
A systematic review and meta-analysis by Stanton et al was updated in 2017 (Stanton, 2011). A total of 22 trials with 591 participants met inclusion criteria; in the update, reviewers only included high-quality trials (see above).
Randomized Controlled Trials
Kim published an RCT on the effect of EMG on upper-extremity functions in patients who have had a stroke (Kim, 2017). Patients were randomized to traditional rehabilitation therapy (n=15) or traditional rehabilitation therapy plus EMG biofeedback training (n=15). Upper-limb function was measured by Fugl-Meyer Assessment (FMA) and Manual Function Test (MFT), and activities of daily living were measured using the FIM instrument. Both FMA and MFT scores improved significantly more in the patients receiving EMG biofeedback. However, there was not a significant difference in FIM score improvement between groups.
Yang published an RCT on the effect of biofeedback weight-bearing training on the ability to sit/stand/sit and on stability among patients who have had a stroke (Yang, 2016). Patients were randomized to biofeedback weight-bearing training (n=15) or functional weight-bearing training (n=15). Outcomes were time to sit/stand/sit and stability (measured by BioRescue, which detects an area of center of pressure). Comparison statistics were calculated for pre- and post-training results, and between treatment groups. Both outcomes significantly improved in the biofeedback group but not in the control group.
Ghomashchi published an RCT evaluated the effect of visual biofeedback on postural balance disorders in patients who have had a stroke (Ghomashchi, 2016). Patients received conventional physical therapy and balance training exercises. During balance training, 16 patients were randomized to visual biofeedback and 15 patients to no visual information. Outcomes were the center of pressure and approximate entropy. Both groups experienced improvements in postural control, with no significant differences between rehabilitation methods.
MULTIPLE SCLEROSIS
A crossover study by van der Logt et al evaluated the effect of vibrotactile biofeedback for trunk sway on balance control in patients with multiple sclerosis (Logt, 2016). Ten patients performed a series of stance and gait tasks while trunk sway was measured using a SwayStar device attached to the waist. Patients underwent the series of tasks with and without an add-on to the SwayStar device, which provided patients with direction-specific vibrotactile feedback during the tasks. When patients performed the tasks with vibrotactile biofeedback, there was a general reduction in trunk sway, though not all the reductions differed significantly with trunk sway when performing the tasks without vibrotactile biofeedback. Studies with larger sample sizes are needed.
SLEEP BRUXISM
Randomized Controlled Trials
Sato et al published a study on the use of EMG biofeedback training for daytime clenching and its effect on sleep bruxism (Sato, 2015). Patients were monitored for 5 hours of daytime and night time and were randomized to EMG biofeedback (n=7) or to a control group (n=5). Patients in the biofeedback group received a small auditory signal in the daytime when clenching activity was detected. There were significant decreases in EMG events during weeks 2 and 3 in the biofeedback group during the daytime, and the decreases in events carried over into the night time. There were no decreases in EMG events in the control group.
2019 Update
A literature search was conducted through August 2019. There was no new information identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Lehrer et al examined the efficacy and safety of HRVB on asthma to determine if the treatment could substitute for the controller or rescue medication and whether HRVB controls airway inflammation (Lehrer, 2018). In the 2-center trial, 68 paid steroid-naive volunteers with mild-to-moderate asthma received 3 months of HRVB or a comparison condition consisting of electroencephalography alpha biofeedback with relaxing music and relaxed paced breathing. Both treatment conditions showed similar significant improvements on the methacholine challenge test, asthma symptoms, and asthma quality of life, and the administration of albuterol after biofeedback sessions produced a large improvement in pulmonary function test results. Trial data would suggest that HRVB not be considered as an alternative to asthma controller medications.
In a case series, Pellegrino et al tested the use of visual biofeedback in reducing postural control deficits on 11 chronic stroke survivors (Pellegrino, 2017). Each participant was assessed using the Berg Balance Scale, Trunk Impairment Scale, and the Nottingham Sensory Assessment Scale for trial inclusion. The test method involved seating each participant on a custom-built force platform and mapping their initial center of pressure positions. The trial had 4 phases: familiarization, training, and pre- and post-training tests. After familiarization and training, subjects were tested to observe if and to what extent they could transfer performance improvement obtained with visual feedback training to the conditions where they have to move (1) without visual feedback, (2) in different directions, and (3) respond to different displacement amplitudes. The study found that most stroke survivors were able to perform the required task and improve task performance during the training phase when provided visual feedback, however, without visual feedback, most showed no improvement on pre-training performance. The authors concluded that postural training based exclusively on continuous visual feedback provided limited benefits. The small sample size and design limit conclusions to be drawn from the study results.
Jokubauskas et al updated the systematic review by Wang on the management of sleep bruxism with biofeedback (Jokubauskas, 2018). Five databases were searched for literature published after the original 2012 search. Six relevant publications were included (total N=86 adults), and of these studies, 4 were RCTs and 2 were uncontrolled before-after studies. For the quantitative synthesis, 2 additional studies were included from the original Wang review. Contingent electrical stimulation, audio feedback, and a maxillary biofeedback splint were among the biofeedback techniques investigated, and all studies measured sleep bruxism with EMG with the exception of one, which used a mini wireless biofeedback device that analyzed bite force. The primary outcome of the analysis was the number of sleep bruxism episodes per hour detected by EMG recording. Secondary outcomes of sleep quality and pain-related outcomes were also investigated in the studies, and 1 study reported on patient-perceived symptom change. Overall, the quality of these studies was assessed as low to moderate due to imprecision and inconsistency between studies, and risk of bias was graded as high to moderate. Despite limitations of the studies, the use of biofeedback to treat sleep bruxism has shown some effectiveness and is relatively safe and noninvasive.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2020. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Taghizadeh et al hypothesized that HRVB)could decrease vulnerability to stress-induced pulmonary impairment in patients with asthma (Taghizadeh, 2019)., Twenty-two healthy women and 22 women with asthma participated in the study. Eleven participants from each group were randomly allocated to either HRVB or a control group. Using spirometry, all participants’ lung function was tested at baseline and after performing the Stroop color-word task. Before the 10-minute Stroop test, each group underwent 20 minutes of either HRVB (treatment group) or maintained a state of relaxed alertness while listening to classical music (control group), after which the groups had similar stress levels as self-reported on a visual analog scale. After the test, all participants again rated their stress levels. All four groups were statistically significantly stressed (p < .001). Although the healthy group who underwent HRVB reported significantly less stress than the healthy control group (p =.034), the participants with asthma did not experience this effect. In fact, larger stress-induced HRV changes suggested an exaggerated response in asthmatic participants compared to the healthy ones. However, spirometry parameters, which were monitored throughout the experimental procedures, showed that HRVB had a protective effect on the participants with asthma as well as enhanced the level of forced expiratory volume percent (p = 0.002) and forced vital capacity percent (p < 0.001) as compared to baseline. The authors concluded that HRVB is a promising protective approach to aid lung function and reduce asthma exacerbation caused by stress. Some limitations of the study include using only the Stroop test to induced stress, measuring stress on a subjective visual analog scale, and including only female participants.
Practice Guidelines and Position Statements
American Academy of Neurology
As of September 2019, the American Academy of Neurology has made no recommendations regarding the use of biofeedback for multiple sclerosis, Bell palsy, or orthostatic hypotension due to spinal cord injury.
The American College of Cardiology et al (2017) guidelines on hypertension in adults states that "behavioral therapies, including....biofeedback, lack strong evidence for their long-term BP-lowering effect (Whelton, 2018).”
As of September 2019, the American College of Obstetricians and Gynecologists has made no recommendations on the use of biofeedback for pain management during labor or to prevent preterm birth.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Ambrosini et al published an RCT on the effect of visual biofeedback on gait and walking ability in patients who have had a first-time stroke (Ambrosini, 2020). Patients were randomized to receive 20 minutes of visual biofeedback training and 70 minutes of usual rehabilitation care (n=34) or 90 minutes of usual rehabilitation care (n=34). Groups experienced similar improvements in gait speed, 6-minute walking test, Functional Independence Measure scores, and Berg Balance Test scores, with no significant differences between groups observed. Outcomes were reported at the end of 6 weeks of treatment; although follow-up was attempted at 6 months, over half of the patients were unavailable for follow-up assessments, so longer term effects of biofeedback training could not be assessed.
Ghanbari Ghoshchi et al published an RCT on the effects of technological rehabilitation (using audio or visual biofeedback) on activities of daily living and return to work among 48 patients who have had a stroke (Ghanbari Ghoshchi, 2020). All patients attended 3 rehabilitation sessions per day on 3 days per week for 1 month; each session was 40 minutes in length. Patients randomized to the technological rehabilitation group had 400 minutes of audio or visual biofeedback training included in their rehabilitation sessions. Ability to perform activities of daily living was measured using the modified Barthel Index. No significant between-group differences were observed 6 months after therapy was completed. Return to work may have been influenced by other factors, including patient age, economic status, and previous occupation.
One RCT by Bergmann et al has been published (Bergmann, 2020). This trial (N=41) examined the use of a full-occlusion biofeedback splint for sleep bruxism and pain associated with temporomandibular disorder. The biofeedback splint was compared to an adjusted occlusal splint. Although a statistically significant difference in total duration of bruxism events per hour was observed at 1 month, this difference was no longer significant at 3 months, and no significant difference was seen in the number of bursts per hour. Patients in the biofeedback splint group had a greater decrease in general pain perception at 3 months.
In 2016, the American Heart Association and the American Stroke Association guidelines on adult stroke rehabilitation and recovery state that the usefulness of biofeedback during gait training in patients after stroke is uncertain (Winstein, 2016).
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Maynart et al compared respiratory and heart rate biofeedback plus usual care to usual care alone in 36 patients with moderate to severe depression or dysthymia (Maynart, 2021). After 6 weeks (6 sessions of biofeedback training), the biofeedback plus usual care group had less severe depression as measured by the Beck Depression Inventory (BDI) than the usual care alone group. An additional preliminary open-label RCT by Park and Jung (2020) compared respiratory sinus arrhythmia biofeedback plus usual care to usual care alone in 30 Korean patients with major depressive disorder (Park, 2020). After 4 weeks (6 sessions of biofeedback), the biofeedback plus usual care group had greater improvements in Hamilton Depression Rating Scale (HAM-D) scores compared to the group receiving usual care alone. Improvements in other clinical measures, including the BDI, were not significantly different between groups.
A systematic review and meta-analysis by Xie et al included 6 RCTs (N=222) comparing postsurgical knee rehabilitation programs with and without EMG biofeedback (XIe, 2021). Sample sizes of individual trials ranged from 16 to 66 patients. In a meta-analysis of data from 5 RCTs (n=146), range of motion was improved with biofeedback (standardized mean difference, -0.48; 95% CI, -0.82 to -0.14; p=.006; I2=37%). However, 4 of the 5 individual trials in the range of motion analysis found no significant benefit with EMG biofeedback compared to conventional rehabilitation methods; only the smallest trial (N=16), measuring passive range of motion 6 weeks after anterior cruciate ligament reconstruction, found a significant improvement with EMG biofeedback. The studies were heterogenous in terms of the intervention intensity, the comparators used, and the type of knee surgery, as well as the specific range of motion endpoint used (passive vs. active range of motion). The range of motion findings of the meta-analysis may have been driven by the strong positive findings in a single trial and may not be generalizable to other settings. Biofeedback was not associated with greater improvements in pain or physical function. Trials were generally limited by small sample sizes and short follow-up periods.
As of September 2021, the Global Initiative for Asthma guidelines make no recommendations regarding the use of biofeedback for asthma (Global Initiative for Asthma, 2021).
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2023. No new literature was identified that would prompt a change in the coverage statement.
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