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
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
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.
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.
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.
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.
Objective: This trial aimed to test the effectiveness of a wearable pulsed electromagnetic fields (PEMF) device in the management of pain in knee OA patients.
Pain Manag. 2015;5(6):413-23.
Rawe IM, Kotak DC.
Objective: 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.
Pain Manag. 2014 Jan;4(1):37-43.
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.
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.
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.
Objective: 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).
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.
Objective: 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.
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.
Published Clinical Literature
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 firstname.lastname@example.org.