Clinical Evidence

BioElectronics has conducted a series of high quality randomized placebo controlled clinical trials as well as large studies on user populations (Registry Studies) to show efficacy and effectiveness of the medical devices. This has resulted in market clearance from the US FDA for musculoskeletal pain and postoperative pain and reimbursement from the UK National Health Service (NHS) for musculoskeletal pain. Further clinical studies have been conducted and are in the process of being published, and other clinical studies are ongoing and are aimed at continuing to build the clinical evidence for musculoskeletal pain and postoperative pain. An overview of the mechanism of action and clinical evidence can be found here:

BioElectronics Corporation Mechanism of Action & Clinical Evidence

Click here to view Mechanism of Action & Clinical Evidence

RecoveryRx has also been used to treat a variety of chronic wound pain and promote tissue healing. Clinical evidence for chronic wound care can be seen here (Click Here to Learn More About Wound Care)

We are conducting clinical trials to expand the clinical applications of our medical device, these include clinical studies for menstrual pain and overactive bladder. A preliminary study on menstrual pain using the Allay medical device indicated good efficacy (Click Here to View Complete Study) and a full high quality randomized placebo controlled trial is being conducted in the UK by the NHS (Click Here to View Complete Study).

Abstract of published clinical studies are can be seen below with links to the full peer reviewed journal publications.

Published Clinical Literature

ActiPatch: Musculoskeletal Pain Studies

Prospective Six-Month Study of Chronic Pain Sufferers: A Novel OTC Neuromodulation Therapy

Pain Research and Management 2019

Richard Staelin, Sree N. Koneru,and Ian M Rawe

Objective. To assess the durability of treatment over various chronic pain conditions of an emerging, nonprescription electromagnetic neuromodulation device that uses pulsed shortwave therapy. Methods. A 6-month prospective study, involving 240chronic pain sufferers, 94% of whom reported using pain pills and 98% reported using pain therapies prior to entering the study. Their average baseline pain was 8.2 VAS points before treatment; they had a pain duration of 6.5 years, and they were positive responders to pulsed shortwave therapy in an initial 7-day trial. Prospective assessments were obtained at intervals of 3, 4, and 6months following a retrospective 7-day assessment. Longitudinal analyses were conducted to determine pain relief trends after the initial 7-day device use. Results. Seven days after initial treatment, the average pain was reduced to 2.9, a 65% pain reduction for the study subjects. At the 6-month measurement, the average pain was 3.3, a 60% pain reduction from baseline. Only 17% of the subjects saw their pain level increase although this new level was still lower than baseline pain. Pain relief translated into improved quality of life and reduced medication use for the majority of the subjects. -ere were no significant adverse side effects reported over the 6 months of use. Conclusion. Ninety-seven percent of the recruited subjects, all of whom had previously reported clinically significant pain relief using the 7-day PSWT device, sustained this relief for 6 months by using the device on an as-needed basis.

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Chronic pain intervention using pulsed shortwave therapy: the relationship between pain demographics and central sensitization inventory.

Pain Manag. 2019 May;9(3):283-296.

Koneru SN, Staelin R, Rawe IM.

Aim: The central sensitization inventory (CSI) is a validated, patient-reported questionnaire that quantifies symptoms of hypersensitivity disorders such as chronic pain, for which central sensitization (CS) may be the etiology. Objective: To investigate the analgesic effectiveness of ActiPatch and analyze the relationship between baseline CSI scores and demographics of chronic pain sufferers. Methods: Upon completing a 7-day ActiPatch trial, baseline CSI scores along with other assessment measures were obtained via e-mail from 174 chronic pain sufferers. Conclusion: CSI scores were positively correlated with gender (higher for women), baseline visual analog scale scores and pain duration. ActiPatch was found to be effective in reducing baseline pain for all subjects by an average of 4.3 visual analog scale points.

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An over-the-counter central sensitization therapy: a chronic back pain registry study of pain relief, medication use and their adverse effects.

Pain Manag. 2017 Mar;7(2):99-111.

Staelin R, Koneru SN, Rawe IM.

AIM: Back pain, the most prevalent musculoskeletal chronic pain condition, is usually treated with analgesic medications of questionable efficacy and frequent occurrence of adverse side effects.

OBJECTIVE: The objective was to determine the effectiveness of the ActiPatch medical devices in reducing chronic back pain, document medication related adverse side effects and establish their impact on quality of life.

METHODS: Upon completing a 7-day trial, subjects were contacted via email with an assessment form using the Constant Contact email program. A total of 1394 responses were collected from subjects who used the device for back pain.

CONCLUSION: Medication adverse effects are common and impact quality of life in the lay population. ActiPatch is an effective intervention for the majority of subjects for treating chronic back pain, although this requires further investigation in randomized clinical trials.

KEYWORDS: adverse side effects; analgesics; chronic back pain; medication reduction; pain relief; pulsed shortwave therapy (PSWT)

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Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial.

Rheumatology (Oxford). 2016 Apr;55(4):755-62.

Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF.

OBJECTIVES:This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients.

METHODS:In this randomized [with equal randomization (1:1)], double-blind, placebo-controlled clinical trial, patients with radiographic evidence of knee OA and persistent pain higher than 40 mm on the visual analog scale (VAS) were recruited. The trial consisted of 12 h daily treatment for 1 month in 60 knee OA patients. The primary outcome measure was the reduction in pain intensity, assessed through VAS and WOMAC scores. Secondary outcomes included quality of life assessment through the 36-item Medical Outcomes Study Short-Form version 2 (SF-36 v2), pressure pain threshold (PPT) and changes in intake of NSAIDs/analgesics.

RESULTS:Sixty-six patients were included, and 60 completed the study. After 1 month, PEMF induced a significant reduction in VAS pain and WOMAC scores compared with placebo. Additionally, pain tolerance, as expressed by PPT changes, and physical health improved in PEMF-treated patients. A mean treatment effect of -0.73 (95% CI – 1.24 to – 0.19) was seen in VAS score, while the effect size was -0.34 (95% CI – 0.85 to 0.17) for WOMAC score. Twenty-six per cent of patients in the PEMF group stopped NSAID/analgesic therapy. No adverse events were detected.

CONCLUSION:These results suggest that PEMF therapy is effective for pain management in knee OA patients and also affects pain threshold and physical functioning. Future larger studies, including head-to-head studies comparing PEMF therapy with standard pharmacological approaches in OA, are warranted.

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A UK registry study of the effectiveness of a new over-the-counter chronic pain therapy.

Pain Manag. 2015;5(6):413-23.

Rawe IM, Kotak DC.

BACKGROUND: The ActiPatch(®) (BioElectronics Corporation, MD, USA) pulsed shortwave therapy device has been shown to be clinically effective in three double-blind randomized controlled pain studies. However, the effectiveness of this device in a broader population of chronic musculoskeletal pain sufferers, affected by a variety of etiologies in different regions of the body, has not been studied.

AIM: The objective of this registry study was to assess the effectiveness and satisfaction of the ActiPatch device in the general population of chronic pain sufferers.

METHODS: A total of 44,000 subjects completed the trial, with 5000 assessments of the device collected.

CONCLUSION: The ActiPatch device appears to provide a clinically meaningful reduction of chronic musculoskeletal pain affecting different locations of the body caused by a variety of etiologies.

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The case for over-the-counter shortwave therapy: safe and effective devices for pain management.

Pain Manag. 2014 Jan;4(1):37-43.

Rawe IM.

Abstract:

Pulsed shortwave diathermy, an electromagnetic therapy, has been in clinical use for acute and chronic musculoskeletal pain for many decades. Innovation, miniaturization and advances in technology have allowed for the development of a new generation of shortwave devices that deliver a localized, low fixed dose of shortwave therapy. Clinical research has shown that these novel shortwave devices can be used safely in order to reduce acute and chronic pain, as well as the need for pain medications. Their ease of use and safety profile make low-dose shortwave devices an attractive alternative, or adjunct therapy, to pharmacological-based pain therapies.

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Pulsed radiofrequency electromagnetic field therapy: a potential novel treatment of plantar fasciitis.

J Foot Ankle Surg. 2012 May-Jun;51(3):312-6.

Brook J, Dauphinee DM, Korpinen J, Rawe IM.

Abstract:

Plantar fasciitis is a common cause of heel pain, and although treatments are usually conservative, they can take up to 2 years to achieve resolution. A double-blind, multicenter, randomized, placebo-controlled study was used to evaluate a small, wearable, extended-use pulsed radiofrequency electromagnetic field (PRFE) device as a treatment of plantar fasciitis. A total of 70 subjects diagnosed with plantar fasciitis were enrolled in the present study. The subjects were randomly assigned a placebo or active PRFE device. The subjects were instructed to wear the PRFE device overnight, record their morning and evening pain using a 0- to 10-point visual analog scale (VAS), and log any medication use. The primary outcome measure for the present study was morning pain, a hallmark of plantar fasciitis. The study group using the active PRFE device showed progressive decline in morning pain. The day 7 AM-VAS score was 40% lower than the day 1 AM-VAS score. The control group, in comparison, showed a 7% decline. A significantly different decline was demonstrated between the 2 groups (p = .03). The PM-VAS scores declined by 30% in the study group and 19% in the control group, although the difference was not significant. Medication use in the study group also showed a trend downward, but the use in the control group remained consistent with the day 1 levels. PRFE therapy worn on a nightly basis appears to offer a simple, drug-free, noninvasive therapy to reduce the pain associated with plantar fasciitis.

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RecoveryRx: Postoperative Pain Clinical Studies

Pulsed Electromagnetic Fields for Postsurgical Pain Management in Women Undergoing Cesarean Section: A Randomized, Double-Blind, Placebo-controlled Trial.

Clin J Pain. 2017 Feb;33(2):142-147.

Khooshideh M1, Latifi Rostami SS, Sheikh M, Ghorbani Yekta B, Shahriari A.

OBJECTIVES: To evaluate the efficacy of pulsed electromagnetic field (PEMF) in relation to reducing postoperative pain, analgesic use, and wound healing in patients undergoing Cesarean section (C-section).

METHODS: This randomized, double-blind, placebo-controlled trial evaluated 72 women who underwent elective C-section. Thirty-six patients were assigned to the active-PEMF and 36 to the sham-PEMF groups. The participants were asked to report their pain intensity on a Visual Analog Scale (VAS) at 2, 4, 6, 12, and 24 hours and 2, 4, and 7 days after surgery. The amount of analgesics used was recorded. The surgical site was evaluated to assess the wound-healing process on the seventh postoperative day.

RESULTS: Postoperative pain VAS scores were significantly lower in the active-PEMF group in all the measured periods within the early and the late postoperative periods. Fewer women in the active-PEMF group experienced severe postoperative pain within 24 hours postoperatively (36% vs. 72%, P=0.002). Analgesic use during the first 24 hours after C-section was 1.9-times lower in the active-PEMF group (1.6±0.7 vs. 3.1±1.2, P<0.001). The total analgesic use during the seventh postoperative days was 2.1-times lower in the active-PEMF group than in the sham group (1.7±0.7 vs. 3.7±1.1, P<0.001). Seven days postoperatively, patients in the active-PEMF group had better wound healing with no exudate, erythema, or edema (P=0.02).

CONCLUSIONS: PEMF treatment after C-section decreases postsurgical pain, analgesic use, and surgical wound exudate and edema significantly, and is associated with a high level of patient satisfaction.

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Pulsed electromagnetic fields for postoperative pain: a randomized controlled clinical trial in patients undergoing mandibular third molar extraction.

Oral Surg Oral Med Oral Pathol Oral Radiol. 2015 Mar;119(3):293-300.

Stocchero M, Gobbato L, De Biagi M, Bressan E, Sivolella S.

OBJECTIVES: The clinical efficacy of a wearable pulsed electromagnetic field (PEMF) therapy device was assessed in terms of pain and quality of healing after tooth extraction.

STUDY DESIGN:  This randomized, parallel design, placebo-controlled study involved 120 patients undergoing unilateral mandibular third molar extraction and assigned to three groups after surgery. Test and placebo patients wore enabled or disabled PEMF devices, respectively, and controls wore no device. Patients recorded pain (on the visual analog scale) and analgesic use for a week, after which healing complications were assessed.

RESULTS: Test patients had only slightly lower visual analog scale scores and analgesic use, but significantly fewer cases of dehiscence than placebo patients.

CONCLUSIONS: PEMF therapy delivered by a wearable device improved soft tissue healing and may be a useful adjunct for pain management after oral surgery.

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Control of postoperative pain with a wearable continuously operating pulsed radiofrequency energy device: a preliminary study.

Aesthetic Plast Surg. 2012 Apr;36(2):458-63.

Rawe IM, Lowenstein A, Barcelo CR, Genecov DG.

BACKGROUND: Pulsed radiofrequency energy (PRFE) has long been reported to have a therapeutic effect on postoperative pain. In this study, a portable, wearable, low-energy-emitting PRFE therapy device was used to determine the control of postoperative pain after breast augmentation surgery.

METHODS: The study enrolled 18 healthy women who underwent breast augmentation purely for aesthetic considerations. Postoperative pain after surgery was assessed with a 0- to 10-point visual analog scale (VAS). Baseline pain scores were taken at completion of the operation, and the patients were randomly assigned coded PRFE devices that were either active or placebo devices. For 7 days, VAS scores were recorded twice daily (a.m. and p.m.). Medication use also was logged for 7 days. The PRFE devices were left in place and in continuous operation for the 7 days of the study.

RESULTS: All the patients tolerated the PRFE therapy well, and no side effects were reported. The VAS scores for the active group were significantly lower on postoperative day 1. By day 7, the baseline VAS remaining in the active group was 7.9% versus 38% in the placebo group. Together with lower VAS scores, narcotic pain medication use was lower in the patient group that received PRFE therapy.

CONCLUSION: Postoperative pain is significantly lower with PRFE therapy. According to the findings, PRFE therapy in this form is an excellent, safe, drug-free method of postoperative pain control.

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Published Clinical Literature

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We welcome contacts from the medical community regarding interest from investigators who wish to research basic science or clinical  applications of our medical devices, have ideas for improved product application or questions on our products. Please contact Ian Rawe, Director of Clinical Research at irawe@bielcorp.com.