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

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 240 chronic 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 6 months 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. There 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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

The use of a portable, wearable form of pulsed radio frequency electromagnetic energy device for the healing of recalcitrant ulcers: a case report.

Pulsed radio frequency energy (PRFE) has successfully been used to treat diabetic and venous stasis ulcers. In this case report, a lightweight wearable form of a PFRE device was evaluated and used to treat three diabetic foot ulcers and one venous stasis ulcer. The ulcers were present on the four patients for more than 3 months and had failed to heal after conventional treatment. A lightweight battery-powered, wearable form of PRFE device was introduced as a treatment and used 6-8 hours per day for a period of 6 weeks. All patients after 1 week of therapy showed improvement and wound size was seen to decrease. Patient 1 had a venous stasis ulcer, and reported significant pain relief after 2 weeks treatment. Patients 2 and 3 achieved complete healing after 3 weeks treatment, and patients 1 and 4 had a 95% and 88% reduction in wound size, respectively, after the 6-week study period. Both these patients continued to complete healing using the PRFE device after the 6-week study period. PRFE treatment delivered in the form of a wearable lightweight patch appears to offer promise in the treatment of recalcitrant chronic wounds.