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. • Subjects in this study had chronic back pain (CBP), with a mean pain duration averaging 6.1 years.• Pain etiologies demonstrated a heterogeneous subject population of CBP sufferers.• About 96% of the subjects were using analgesics medications averaging 2.5 per subject, with 71% using prescription analgesics.• The majority of individuals using analgesic medications for CBP report less than adequate pain relief.• Adverse effects from pain medications are common (66%) for CBP sufferers.• CBP sufferers, who report chronic pain for longer than 2 years, also detail using approximately 25% more prescription analgesics than those who have experienced the pain for less than 2 years.• The number of adverse effects is directly proportional to the number of prescription analgesics being used.• The increase in the number of adverse side effects negatively impacts quality of life.• The majority of CBP users, upon using the ActiPatch®, reported a clinically significant reduction in pain within 7 days.• Nearly 50% of the study subjects were able to eliminate or decrease analgesic medications after 7 days of use of the medical device.• The ActiPatch was effective in reducing CBP for the majority of subjects as well as reducing their analgesic use.For reprint orders, please contact: reprints@futuremedicine.com
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.
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.
Electroceuticals are medical devices that employ electric signals to alter the activity of specific nerve fibers to achieve therapeutic effects. The rapid growth of RF microelectronics has resulted in the development of very small, portable, and inexpensive shortwave and microwave radio frequency (RF) amplifiers, raising the possibility of utilizing these new RF technologies to develop non-contact electroceutical devices. However, the bio-electromagnetics literature suggests that beyond 10 MHz, RF fields cannot influence biological tissue, beyond simple heating, because effective demodulation mechanisms at these frequencies do not exist in the body. However, RF amplifiers operating at or near saturation have non-linear interactions with complex loads, and if body tissue creates a complex loading condition, the opportunity exists for the coupled system to produce non-linear effects, that is, the equivalent of demodulation may occur. Correspondingly, exposure of tissue to pulsed RF energy could result in the creation of low frequency demodulation components capable of influencing tissue activity. Here, we develop a one-dimensional, numerical simulation to investigate the complex loading conditions under which such demodulation could arise. Applying these results in a physical prototype device, we show that up to7.5% demodulation can be obtained for a 40 MHz RF field pulsed at 1 KHz. Implications for this research include the possibility of developing wearable, electromagnetic electroceutical devices.
Assess treatment superiority of pulsed shortwave therapy (PSWT) against COX-2 NSAID therapy, in reducing disability and pain due to cervical osteoarthritis. Two hundred chronic pain suffers (average pain duration about 2 years) diagnosed with cervical osteoarthritis by radiological imaging were randomized into one of two treatment arms: COX-2 NSAID treatment; etoricoxib 60 mg/day for 4 weeks; or PSWT treatment worn 24 h/day for 4 weeks. The primary outcome measure was the 4-week score on the Neck Disability Index (NDI), a 10-question assessment on a 50-point scale. Secondary outcome measures included pain (at rest and during activity) measured on a visual analog scale (VAS) of 0–100 mm, dose count of rescue pain medication (paracetamol) use, and a treatment satisfaction rating. These 4-week scores were compared across the two arms to assess superiority. After 4 weeks of treatment, subjects in both study arms reported statistically significant (p < 0.0001) reductions in NDI, with final scores of 11.24-NSAID and 9.34-PSWT, VASrest, with final scores of 30.08-NSAID; 22.76-PSWT, and VASactivity, with final scores of 36.40-NSAID; 27.42-PSWT. The absolute reduction from baseline in NDI was significantly greater in the PSWT arm than NSAID arm (3.66 points; 95% CI 2.3 to 5.02; p < 0.0001). Similarly, the reductions from baseline in VASrest and VASactivity were significantly greater in the PSWT arm than NSAID arm (10.89 mm; 95% CI 6.90 to 14.87; p < 0.0001; and 12.05 mm; 95% CI 7.76 to 16.33; p < 0.0001, respectively). The PSWT arm used 50% less rescue pain medication. Eleven adverse effects were reported in the NSAID arm and zero in the PSWT arm. Both NSAID and PSWT treatments resulted in statistically significant improvements in quality of life (NDI) and reduction in pain (VAS) resulting from cervical osteoarthritis. However, the PSWT intervention showed superior improvements in all outcome measures when compared to the NSAID arm with no adverse effects. Clinicaltrials.gov (NCT03542955).
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