Clinical trial NCT03240146: Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain
Official title: Pulsed Shortwave Therapy (PSWT) Treatment for Chronic Musculoskeletal Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: BioElectronics Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: Chronic low back pain is a major public heath challenge for a number of reasons including prevalence, seriousness, vulnerable populations, the utility of population health strategies, and the importance of prevention at both the population and individual levels. Its incidence and prevalence are increasing with an aging population and the rise in obesity. When considering the location of chronic pain and its aetiology, back pain was the most common location with arthritis/osteoarthritis being the most common cause. Chronic low back back pain is costly to nations-not just in terms of health care expenditures and disability compensation but also in terms of lost school days, lost productivity and employment, reduced incomes, and lost potential and quality of life.

Eligibility criteria: 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 would be acceptable).
* Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.
* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Visual Analogue Pain score
timeFrame: 4 weeks
measure: The Pain and Sleep Questionnaire three-item index
timeFrame: 4 weeks
measure: Analgesic Medication use
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Primary Care
state: Alabama
Study officials:
affiliation: North Alabama Primary Care
name: Chandra Koneru, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BioElectronics Corporation
name: Sree Koneru, Ph.D
role: STUDY_DIRECTOR
affiliation: BioElectronics Corporation
name: Ian Rawe, Ph.D.
role: STUDY_CHAIR
References: