Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain
CompletedNot applicableNCT03240146
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The ActiPatch is a cutaneous device which is CE marked approved for relief of pain and has FDA clearance as an over the counter device for the adjunctive treatment of osteoarthritis of the knee and plantar fasciitis. It is taped over the affected area and stimulation at a high frequency is reported to alleviate pain with no sensation. By randomising patients between application of an active device or a dummy device and assessment of disability and pain scores at four weeks the efficacy or otherwise can be established. Chronic low back pain is a major health problem and if effective this has major economic implications as the device is cheap and safe.
Study details
- Official title
- Pulsed Shortwave Therapy (PSWT) Treatment for Chronic Musculoskeletal Low Back Pain
- Conditions
- Interventions
- Device: Pulsed Shortwave Therapy
- Sponsor
- BioElectronics Corporation
- Start date
- 2017-09-28
- Primary completion
- 2017-12-21
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Participant is willing and able to give informed consent for participation in the trial. * In the Investigator's opinion, is able and willing to comply with all trial requirements. * Male or female ages 18 or above with stable chronic lower back pain * Females of childbearing must be on birth control or practice abstinence during the study period o Women of childbearing age will be screened with a urine pregnancy test. Women of childbearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. * ≥3 months duration of chronic low back pain * a current VAS pain rating ≥5/10 * no radiating pain below the knee * Most of the pain in the body is present in the lower back or buttock, NOT in the lower extremities, as determined during screening by the principal investigator. The investigator will verbally ask the participant if most of the pain being experienced is in the lower back/buttock area, and rely on the response for inclusion into the study. * able to complete and tolerate treatment for the study period. Exclusion Criteria: * Female participant who is pregnant. * Significant renal or hepatic impairment confirmed by medical history. * Prior home use of pulsed shortwave therapy. * Prior history of spinal fusion or failed spinal surgery syndrome. * Laminectomy, laminotomy or discectomy within 12 months of enrollment. * Diagnostic or interventional injections or any low back surgeries not mentioned above, including radiofrequency neuroablation within 6 months of enrollment. * The addition of strong opiates (hydrocodone, oxycodone, morphine), pregabalin and gabapentin to the treatment regime during the course of the trial * Current implanted cardiac demand pacemakers, defibrillators, cardiac pumps, spinal stimulators or other implanted electronic devices. * Patients using personal home based electrical stimulation devices are excluded * Patients with other concomitant illnesses (e.g., malignancy, osteoporosis) which, in the opinion of the investigator, would preclude successful patient participation will also be excluded * Active psychiatric disorders will be excluded (e.g. use of antipsychotic medication, bipolar disorder, schizophrenia). * Patients diagnosed with history of significant mood disorder will be excluded (e.g., depression or anxiety with adequate control woul…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03240146