Coverage Policy Manual
Policy #: 2011070
Category: Medicine
Initiated: October 2011
Last Review: July 2018
  Electrical Stimulation, Auricular Stimulation and Cranial Electrotherapy Stimulation

Description:
Cranial electrotherapy stimulation (CES), also known as cranial electrical stimulation, transcranial electrical stimulation, or electrical stimulation therapy, delivers weak pulses of electrical current to the earlobes, mastoid processes, or scalp with devices such as the Alpha-Stim®. Auricular electrostimulation involves the stimulation of acupuncture points on the ear. Devices, including the P-Stim™ and E-pulse, have been developed to provide ambulatory auricular electrical stimulation over a period of several days. CES and auricular electrostimulation are being evaluated for a variety of conditions, including pain, insomnia, depression, anxiety, and weight loss.
 
Background
Interest in cranial electrotherapy stimulation (CES) began in the early 1900s with the theory that weak pulses of electrical current would lead to a calming effect on the central nervous system. The technique was further developed in the U.S.S.R. and Eastern Europe in the 1950s as a treatment for anxiety and depression, and use of CES later spread to Western Europe and the U.S. as a treatment for a variety of psychological and physiological conditions. Presently, the mechanism of action is thought to be the modulation of activity in brain networks by direct action in the hypothalamus, limbic system and/or the reticular activating system. One device used in the U.S. is the Alpha-Stim CES, which provides pulsed, low-intensity current via clip electrodes that attach to the earlobes. Other devices place the electrodes on the eyelids, frontal scalp, mastoid processes, or behind the ears. Treatments may be administered once or twice daily for a period of several days to several weeks.
 
Other devices have been developed that provide electrical stimulation to auricular acupuncture sites over several days. One device, the P-Stim™, is a single-use miniature electrical stimulator for auricular acupuncture points that is worn behind the ear with a self-adhesive electrode patch. A selection stylus that measures electrical resistance is used to identify 3 auricular acupuncture points. The P-Stim™ device connects to 3 inserted acupuncture needles with caps and wires. The device is pre-programmed to be on for 180 minutes, then off for 180 minutes. The maximum battery life of this single-use device is 96 hours.
 
Regulatory Status
A number of devices for CES have received marketing clearance through the U.S. Food and Drug Administration’s (FDA) 510(k) process. The Alpha-Stim® CES device (Electromedical Products International) received marketing clearance in 1992 for the treatment of anxiety, insomnia, and depression.
 
The P-Stim™ (NeuroScience Therapy Corp) received marketing clearance through the FDA’s 510(k) process in 2006. The P-Stim™ is intended for use as an electro-acupuncture device to stimulate appropriate auricular acupuncture points.
The E-pulse received 510(k) marketing clearance in 2009, listing the P-Stim™ as a predicate device. The E-pulse is a microprocessor-controlled battery-powered unit designed to administer auricular point nerve stimulation treatment for pain therapy over a 96-hour period.
 
Coding
There are no CPT codes that are specific to electrical stimulation of auricular acupuncture points. The following CPT codes might be used:
 
97813: Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient
 
97814: with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s) (List separately in addition to code for primary procedure).
 
The following specific HCPCS code for auricular stimulation became effective April 1, 2012:
S8930: Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with the patient.
 
RELATED POLICIES:
  • 1998154 - Electrical Stimulation, Transcutaneous Electrical Nerve Stimulator
  • 2010005 - Electrical Stimulation, Percutaneous Electrical Nerve Stimulation (PENS) or Percutaneous Neuromodulation           
                 Therapy (PNT)
 
 

Policy/
Coverage:
Effective July 2018
 
This service is a specific contract exclusion in most member benefit certificates of coverage and is not covered.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
For members with contracts without this specific contract exclusion, electrical stimulation of auricular acupuncture points does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without this specific contract exclusion and without primary coverage criteria, electrical stimulation of auricular acupuncture points is considered investigational.  Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
 
For members with contracts without this specific contract exclusion, cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without this specific contract exclusion and without primary coverage criteria, cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) is investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to July 2018
 
This service is a specific contract exclusion in most member benefit certificates of coverage and is not covered.
 
For members with contracts without this specific contract exclusion, electrical stimulation of auricular acupuncture points does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without this specific contract exclusion and without primary coverage criteria, electrical stimulation of auricular acupuncture points is considered investigational.  Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.
 
For members with contracts without this specific contract exclusion, cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without this specific contract exclusion and without primary coverage criteria, cranial electrotherapy stimulation (also known as cranial electrostimulation therapy or CES) is investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to October 2013
 
Electrical stimulation of auricular acupuncture points does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, electrical stimulation of auricular acupuncture points is considered investigational.  Investigational services are considered specific contract exclusions in most member benefit certificates of coverage.

Rationale:
At the time this policy was created, use of the P-Stim had been reported only in European trials. In 2004, Sator-Katzenschlager et al. reported a randomized double-blind controlled study of auricular electro-acupuncture compared to conventional manual auricular acupuncture in 61 patients with chronic low back pain (duration of at least 6 months) (Sator-Katzenschlager, 2004). All needles were connected to the P-Stim device; in the control group, devices were applied without electrical stimulation. Treatment was performed once weekly for 6 weeks, with needles withdrawn 48 hours after insertion. Patients received questionnaires assessing pain intensity and quality, psychological well-being, activity level, and quality of sleep using visual analog scale (VAS). There was a significant improvement in pain at up to 18 weeks’ follow-up. Auricular electro-acupuncture resulted in greater improvement in the outcome measures than that of the control group. For example, at 18-week follow-up, VAS pain intensity was less than 5 in the control group and less than 2 in the electro-acupuncture. This study is limited by the small number of participants. In 2003, this group of investigators had reported similar effects in a small randomized study of 21 patients with chronic cervical pain (Sator-Katzenschlager, 2003).
 
In another European study from 2008, Bernateck et al. reported the use of the P-Stim device in a randomized controlled trial (RCT) of 44 patients with rheumatoid arthritis (Bernateck, 2008). The control group received autogenic training, a psychological intervention in which participants learn to relax their limbs, breathing, and heart. Electro-acupuncture (continuous stimulation for 48 hours at home) and lessons in autogenic training were performed once weekly for 6 weeks. In addition, the control patients were encouraged to use an audiotape to practice autogenic training every day. The needles and devices were removed after 48 hours. Seven patients withdrew from the study before beginning the intervention; the 37 remaining patients completed the study through 3 months of follow-up. The primary outcome measures were the mean weekly pain intensity and the disease activity score (DAS-28). At the end of treatment and at 3-month follow-up, a statistically significant improvement was observed in all outcome measures for both groups. There was greater improvement in the electro-acupuncture group than the control group (e.g., VAS pain 2.79 vs. 3.95) during the treatment period. This difference did not persist at the 3-month follow-up. The clinical significance of a 1-point difference in VAS from this small trial is unclear.
 
In a 2007 review, Sator-Katzenschlager and Michalek-Suberer found that studies on the use of the P-Stim in acute pain (e.g., oocyte aspiration and molar tooth extraction) are contradictory (Sator-Katzenschlager). A 2011 randomized trial from Europe tested the efficacy of the P-Stim in 40 female patients undergoing gynecologic surgery (Holzer, 2011). Patients were randomly assigned to receive auricular acupuncture or sham stimulation. Patients in the control group received electrodes without needles and the P-Stim devices were applied without electrical stimulation. The P-Stim device was placed behind the ear at the end of the operation on all patients while they were still under general anesthesia, and the dominant ear was completely covered with identical dressing in both groups to maintain blinding. Postoperatively, patients received 1,000 mg paracetamol every 6 hours, with additional piritramide given on demand. Needles and devices were removed 72 hours postoperatively. A blinded observer found no significant difference between the 2 groups in consumption of piritramide during the first 72 hours postoperatively (acupuncture vs. placebo: 15.3 mg vs. 13.9 mg, respectively) or on VAS scores taken at 0, 2, 24, 48, and 72 hours (average of 2.32 vs. 2.62, acupuncture vs. placebo, respectively).
 
Summary
The evidence available at this time is insufficient to evaluate the effect of auricular electrostimulation on health outcomes, including acute and chronic pain. Additional randomized studies with a larger number of subjects are needed to evaluate the efficacy of this treatment approach.
 
2012 Update
A search of the MEDLINE database through September 2012 identified no published literature that would prompt a change in the coverage statement.
 
Napadow and colleagues (2012) published a counter balanced, crossover study.  The patients in the study had  chronic pelvic pain (CPP) due to endometriosis.  Interventions included the  evaluation  of  evoked pain analgesia for respiratory-gated auricular vagal afferent nerve stimulation (RAVANS) compared with nonvagal auricular stimulation (NVAS).  RAVANS and NVAS were evaluated in separate sessions spaced at least 1 week apart. Outcome measures included deep-tissue pain intensity, temporal summation of pain, and anxiety ratings, which were assessed at baseline, during active stimulation, immediately following stimulation, and 15 minutes after stimulus cessation.  
 
Results of the study:  RAVANS demonstrated a trend for reduced evoked pain intensity and temporal summation of mechanical pain, and significantly reduced anxiety in N = 15 CPP patients, compared with NVAS, with moderate to large effect sizes (η(2) > 0.2).  
 
In summary, chronic pain disorders such as CPP are in great need of effective, nonpharmacological options for treatment. RAVANS produced promising antinociceptive effects for quantitative sensory testing (QST) outcomes reflective of the noted hyperalgesia and central sensitization in this patient population. Future studies should evaluate longer-term application of RAVANS to examine its effects on both QST outcomes and clinical pain.
 
 
The following clinical trial was listed on clinicaltrials.gov: NCT01278355 - The Feasibility of Integrating Ear Acupuncture for Pain in Patients Being Transported Via the Aeromedical Evacuation System From Ramstein Air Base to Andrews AFB, Maryland USA: An Observational Study is still recruiting.
 
2013 Update
 
A search of the MEDLINE database was conducted through September 2013. There was no new information identified on the use of auricular electrostimulation that would prompt a change in the coverage statement. This update focuses on the use of cranial electrotherapy stimulation.
 
Cranial Electrotherapy Stimulation (CES)
A number of randomized controlled trials and systematic reviews have been published on CES. In 1995, Klawansky et al. published a meta-analysis of 14 randomized trials of CES versus sham (Klawansky, 1995).  Most of the studies were small, with fewer than 50 patients. Meta-analysis was conducted for the treatment of 4 different psychological and physiological conditions: anxiety (8 trials), brain dysfunction from drug or alcohol use (2 trials), headache (2 trials), and insomnia (2 trials). Meta-analysis showed CES to be significantly more effective than sham for anxiety and headache. Of the 8 studies included in the meta-analysis for anxiety, the sample size was generally small, the populations studied were diverse, and only 2 of the studies independently showed CES to be better than sham treatment. For headache, there was a high risk of bias for 1 of the studies and a poor quality rating for the second according to a Cochrane review (see below) (Bronfort, 2004).  Meta-analysis did not find CES to be more effective than sham for brain dysfunction or insomnia.
 
Anxiety: The largest randomized study on anxiety that was included in the 1995 systematic review was a 1976 report by Passini et al (Passini, 1976).  Sixty psychiatric patients with a variety of diagnoses (e.g., alcohol addiction, unipolar depression, bi-polar disorder, anxiety, schizophrenia, personality disorder) and with either anxiety or depression were included. Thirty-minute treatments on 10 successive workdays resulted in significant improvements in both the CES and sham groups on self-ratings of anxiety, depression, and hostility, indicating a large placebo effect. Improvements were not significantly different between the groups, but tended to favor the controls rather than the active CES group.
 
Headache: A 2009 Cochrane review of non-invasive treatments for headaches identified 2 poor quality randomized placebo controlled trials on CES for migraine or tension-type headache (Bronfort, 2004). The trials provided limited evidence that CES is superior to placebo in reducing pain intensity from headache.
 
Chronic Pain: A 2010 Cochrane review of non-invasive brain stimulation techniques for chronic pain identified 8 randomized trials (5 parallel study design and 3 cross-over design with a total of 391 participants) (O’Connell, 2010). Chronic pain conditions included osteoarthritis of the hip and knee, chronic back and neck pain, fibromyalgia, and chronic pain following spinal cord injury. Meta-analysis of 3 trials (133 participants) where it was possible to extract data, found no difference between active CES and sham stimulation on pain at short-term follow-up, leading to the conclusion that CES may be ineffective for chronic pain.
 
In 2011, Tan et al. published a multi-center randomized double-blind sham-controlled trial of CES for chronic neuropathic pain following spinal cord injury (Tan, 2011). The study of 105 participants was funded by the Veterans Affairs Rehabilitation Research and Development Service. Sub-perception CES or sham CES was applied for 1 hour daily at home over 21 days, followed by a 6-month open-label phase to assess “as needed” CES usage. The primary outcome measure was daily pre- to post-session changes in pain ratings. The active and sham groups did not differ significantly on average daily pain ratings before (active=5.60, sham=5.41) or after treatment (active=5.00, sham=5.00), but the active CES group had a statistically greater decrease in pain (0.60 vs. 0.41). This is not a clinically significant difference. The only outcome measure that showed a significant group by time interaction after 21 days of treatment was pain interference, although this measure was not comparable between the groups at baseline. Baseline to post-treatment changes in pain intensity, pain quality, pain beliefs and coping strategies, general physical and mental health status, depressive symptomatology, perceived stress, and anxiety did not differ between groups. Eighteen participants (17%) reported that they were using the device by the sixth month of the open-label phase.
 
Parkinson’s Disease: Shill et al. found no benefit of CES with the Nexalin device for motor or psychological symptoms in a crossover study of 23 patients with early Parkinson’s disease (Shill, 2011).
 
Smoking Cessation: In 1997, Pickworth et al. reported that 5 days of CES was ineffective for reducing withdrawal symptoms or facilitating smoking cessation in a double-blind randomized controlled trial of 101 cigarette smokers who wished to stop smoking (Pickworth, 1997).
 
In summary, a number of randomized double-blind sham-controlled trials along with several systematic reviews have been conducted on CES for a variety of conditions. In spite of the number of trials, there is a lack of evidence for improvement of health outcomes.
 
2014 Update
A literature search conducted through August 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Anxiety and Depression
In 2014, Barclay and Barclay reported a randomized, double-blind, sham controlled trial of the effectiveness of one hour daily of CES in patients with anxiety (n=115) and co-morbid depression (n=23) (Barclay, 2014).  Analysis of covariance showed a significant advantage of active CES over sham for both anxiety (p=.001) and depression (p=.001) over the 5 weeks of treatment. The mean decrease in the Hamilton rating scale for anxiety was 32.8% for active CES versus 9.1% for sham. The mean decrease in the Hamilton rating scale for depression was 32.9% for active CES and 2.6% for sham.
 
A 2014 Cochrane review with a literature search through February 2014 found no high quality randomized
controlled trials of CES versus sham for the treatment of depression (Kavirajan, 2014).
 
Chronic Pain
A 2014 update of the Cochrane review identified 11 randomized trials of CES for chronic pain (O'Connell, 2014).  Metaanalysis of 6 trials (270 participants) found no significant difference between active and sham stimulation, reinforcing the conclusion that CES is not effective for the treatment of chronic pain.
 
Obesity
The same group of investigators reported a randomized double-blinded study of the effects of the P-Stim on weight loss in 56 obese patients (Schukro, 2014). The auricular acupuncture points for hunger, stomach, and colon were stimulated for 4 days per week over 6 weeks. At the end of treatment, body weight was reduced by 3.73% in the active stimulation group and .70% in the sham group (p<.001). From the beginning of treatment to 4 weeks after the end of treatment, body weight was reduced by 5.08% in the active stimulation group and .16% in the sham group (p<.001). Similar changes were observed for BMI (body mass index) and body fat. Further study by these investigators will include a larger sample size and a longer time of observation.
 
The positive effect of electrostimulation that was reported for weight loss requires confirmation in a larger sample of patients. The evidence available at this time is insufficient to determine the effect of auricular electrostimulation on health outcomes, including acute and chronic pain and weight loss.
 
2015 Update
A literature search conducted through July 2015 did not reveal any new information that would prompt a change in the coverage statement.  
 
2016 Update
A literature search conducted through August 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In contrast, a 2015 sham-controlled, double-blind RCT found no significant benefit of CES with the Alpha-Stim for symptoms of depression, anxiety, pain, fatigue, and sleep disturbances in women receiving chemotherapy for breast cancer (Lyon, 2015). This phase 3 trial randomized 167 women with early stage breast cancer to 1 h daily CES or sham stimulation beginning within 48 hours of the first chemotherapy session and continuing until 2 weeks after chemotherapy ended (range, 6-32 weeks). The intensity of the stimulation was below the level of sensation. Active and sham devices were preset at the factory and neither the evaluators nor patients were aware of the treatment condition. Outcomes were measured using validated questionnaires that assessed pain, anxiety and depression, fatigue, and sleep disturbance. There were no significant differences between the active and sham CES groups during treatment. However, the study may be limited by the low levels of symptoms at baseline, resulting in a floor effect, and the low level of stimulation.
 
Another smaller double-blind, sham-controlled RCT (N=30) found no significant benefit of a CES as an add-on in patients with treatment-resistant major depression (Mischoulon, 2015). Both the active and sham groups showed improvements in depression over the 3 weeks of the study, suggesting a strong placebo effect.
 
2017 Update
A literature search conducted through August 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Roh and So reported on a sham-controlled randomized trial (N=50) in healthy women with a focus on changes in blood levels of hormones related to the hypothalamic-pituitary axis (Roh, 2016). However, given that this trial did not include outcomes for individuals with anxiety or depression, it is unclear whether results would be generalizable.
 
Gong and colleagues reported a single-center, unblinded RCT comparing CES (Alpha-Stim) with biofeedback in 74 subjects with functional constipation (Gong, 2016). Eligible patients met Rome III criteria for functional constipation and had been recommended by their physicians for biofeedback therapy. Patients were randomized to biofeedback with CES (n= 38) or biofeedback alone (n=36), and followed at 4 time points (baseline and 3 follow-up visits); however, the duration of time between each follow-up visit does not seem to have been specified. In a repeated-measures analysis of variance model for change from baseline, at the second and third follow-up visits, there were significant differences between groups for the following: Self-Rating Anxiety Scale results (for third visit: 41.8 for CES patients vs 46.8 for controls; p<0.001); Self-Rating Depression Scale results (for third visit: 43.08 for CES patients vs 48.8 for controls; p<0.001) and the Wexner Constipation Score results (for third visit: 10.0 for CES patients vs 12.6 for controls; p<0.001). A subset of patients underwent anorectal manometry, and there were no between-group differences before or after treatment.
 
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through May 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Obesity
Yeh et al randomized 70 patients to electrical stimulation on true acupressure points or sham acupressure points (Yeh, 2015). As part of the 10-week treatment program, all patients received auricular acupressure and nutrition counseling following the electrical stimulation sessions. Both groups experienced significant improvements in body mass index, blood pressure, and cholesterol levels from baseline. However, there was no significant difference between groups.
 
Opioid Withdrawal Symptoms
Evidence on the use of auricular electrostimulation to treat patients with opioid withdrawal symptoms consists of 2 case series with different protocols. Both studies reported successful alleviation of opioid withdrawal symptoms, though, without comparators, conclusions to be drawn from this evidence are limited. These case series are described below.
 
Kroening and Oleson published a case series assessing 14 patients with chronic pain who were scheduled for withdrawal from their opiate medications (Kroening, 1985). During the withdrawal process, patients were given oral methadone, followed by bilateral auricular electroacupuncture for 2 to 6 hours, and periodic intravenous injections of low dose naloxone. On successive days, the methadone doses were halved. By day 7, 12 of 14 patients were completely withdrawn from methadone. Through at least 1-year follow-up, the 12 patients experienced minimal or no withdrawal symptoms and remained off narcotic medications.
 
Miranda and Taca conducted an open-label, uncontrolled, retrospective pilot study to evaluate the effect of neuromodulation with percutaneous electrical field stimulation on opioid withdrawal symptoms (Miranda, 2018). Eight participating clinics provided data on 73 patients who met Diagnostic and Statistical Manual of Mental Health Disorders, 4th edition, criteria for opioid dependence and voluntarily agreed to be treated with the NSS-2 Bridge device. All providers were trained to use the Bridge through online modules. Patients were monitored during the first hour following implantation of the device and sent home with instructions to return for follow-up within 1 to 5 days, depending on the clinic, and to keep the device on for the entire 5-day period. The primary outcome of withdrawal symptom improvement was measured using the Clinical Opioid Withdrawal Scale (COWS), which ranges from 0 to 48 (5 to 12=mild; 13 to 24=moderate, 25 to 36=moderately severe, >36=severe). Another outcome was a successful transition, defined as receiving first maintenance medication on day 5 of the study. Mean baseline COWS score was 20.1. At 20 minutes, mean COWS score decreased to 7.5; at 30 minutes, mean COWS was 4.0; and at 60 minutes, mean COWS was 3.1. At 5-day follow-up, 89% of patients successfully transitioned to maintenance medication.

CPT/HCPCS:
97813Acupuncture, 1 or more needles; with electrical stimulation, initial 15 minutes of personal one-on-one contact with the patient
97814Acupuncture, 1 or more needles; with electrical stimulation, each additional 15 minutes of personal one-on-one contact with the patient, with re-insertion of needle(s) (List separately in addition to code for primary procedure)
S8930Electrical stimulation of auricular acupuncture points; each 15 minutes of personal one-on-one contact with patient

References: Barclay TH, Barclay RD.(2014) A clinical trial of cranial electrotherapy stimulation for anxiety and comorbid depression. J Affect Disord. Aug 2014;164:171-177. PMID 24856571

Bernateck M, Becker M, Schwake C et al.(2008) Adjuvant auricular electroacupuncture and autogenic training in rheumatoid arthritis: a randomized controlled trial. Auricular acupuncture and autogenic training in rheumatoid arthritis. Forsch Komplementmed 2008; 15(4):187-93.

Bronfort G, Nilsson N, Haas M et al.(2004) Non-invasive physical treatments for chronic/recurrent headache. Cochrane Database Syst Rev 2004; (3):CD001878.

Gong BY, Ma HM, Zang XY, et al.(2016) Efficacy of Cranial Electrotherapy Stimulation Combined with Biofeedback Therapy in Patients with Functional Constipation. J Neurogastroenterol Motil. Jul 30 2016;22(3):497-508. PMID 26932836

Holzer A, Leitgeb U, Spacek A et al.(2011) Auricular acupuncture for postoperative pain after gynecological surgery: a randomized controlled trail. Minerva Anestesiol 2011; 77(3):298-304.

Kavirajan HC, Lueck K, Chuang K.(2014) Alternating current cranial electrotherapy stimulation (CES) for depression. Cochrane Database Syst Rev. Jul 8 2014;7:CD010521. PMID 25000907

Klawansky S, Yeung A, Berkey C et al.(1995) Meta-analysis of randomized controlled trials of cranial electrostimulation. Efficacy in treating selected psychological and physiological conditions. J Nerv Ment Dis 1995; 183(7):478-84.

Kroening RJ, Oleson TD.(1985) Rapid narcotic detoxification in chronic pain patients treated with auricular electroacupuncture and naloxone. Int J Addict. Sep 1985;20(9):1347-1360. PMID 2867052

Lyon D, Kelly D, Walter J, et al.(2015) Randomized sham controlled trial of cranial microcurrent stimulation for symptoms of depression, anxiety, pain, fatigue and sleep disturbances in women receiving chemotherapy for early-stage breast cancer. Springerplus. 2015;4:369. PMID 26435889

Miranda A, Taca A.(2018) Neuromodulation with percutaneous electrical nerve field stimulation is associated with reduction in signs and symptoms of opioid withdrawal: a multisite, retrospective assessment. Am J Drug Alcohol Abuse. 2018;44(1):56-63. PMID 28301217

Mischoulon D, De Jong MF, Vitolo OV, et al.(2015) Efficacy and safety of a form of cranial electrical stimulation (CES) as an add-on intervention for treatment-resistant major depressive disorder: A three week double blind pilot study. J. Psychiatr Res. Nov 2015;70:98-105. PMID 26424428

Napadow V, Edwards RR, Cahalan CM, et al.(2012) Evoked pain analgesia in chronic pelvic pain patients using respiratory-gated auricular vagal afferent nerve stimulation. Pain Med. 2012 Jun;13(6):777-89. doi: 10.1111/j.1526-4637.2012.01385.x. Epub 2012 May 8.

O'Connell NE, Wand BM, Marston L et al.(2010) Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev 2010; (9):CD008208.

O'Connell NE, Wand BM, Marston L, et al.(2014) Non-invasive brain stimulation techniques for chronic pain. Cochrane Database Syst Rev. 2014;4:CD008208. PMID 24729198

Passini FG, Watson CG, Herder J.(1976) The effects of cerebral electric therapy (electrosleep) on anxiety, depression, and hostility in psychiatric patients. J Nerv Ment Dis 1976; 163(4):263-6.

Pickworth WB, Fant RV, Butschky MF et al.(1997) Evaluation of cranial electrostimulation therapy on short-term smoking cessation. Biol Psychiatry 1997; 42(2):116-21.

Roh HT, So WY.(2016) Cranial electrotherapy stimulation affects mood state but not levels of peripheral neurotrophic factors or hypothalamic- pituitary-adrenal axis regulation. Technol Health Care. Nov 18 2016. PMID 27886020

Sator-Katzenschlager SM, Michalek-Sauberer A.(2007) P-Stim auricular electroacupuncture stimulation device for pain relief. Expert Rev Med Devices 2007; 4(1):23-32.

Sator-Katzenschlager SM, Scharbert G, Kozek-Langenecker SA et al.(2004) The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular acupuncture. Anesth Analg 2004; 98(5):1359-64, table of contents.

Sator-Katzenschlager SM, Szeles JC, Scharbert G et al.(2003) Electrical stimulation of auricular acupuncture points is more effective than conventional manual auricular acupuncture in chronic cervical pain: a pilot study. Anesth Analg 2003; 97(5):1469-73.

Schukro RP, Heiserer C, Michalek-Sauberer A, et al.(2014) The effects of auricular electroacupuncture on obesity in female patients--a prospective randomized placebo-controlled pilot study. Complement Ther Med. Feb 2014;22(1):21-25. PMID 24559812

Shill HA, Obradov S, Katsnelson Y et al.(2011) A randomized, double-blind trial of transcranial electrostimulation in early Parkinson's disease. Mov Disord 2011; 26(8):1477-80.

Tan G, Rintala DH, Jensen MP et al.(2011) Efficacy of cranial electrotherapy stimulation for neuropathic pain following spinal cord injury: a multi-site randomized controlled trial with a secondary 6-month open-label phase. J Spinal Cord Med 2011; 34(3):285-96.

Yeh ML, Chu NF, Hsu MY, et al.(2015) Acupoint stimulation on weight reduction for obesity: a randomized sham-controlled study. West J Nurs Res. Dec 2015;37(12):1517-1530. PMID 25183702


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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