Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Device: Pulsed Shortwave Therapy

• Registration Number: NCT03240146
• Lead Sponsor: BioElectronics Corporation

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.

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-04
• Study Start: 2017-09-28
• Primary Completion: 2017-12-21
• Study Completion: 2017-12-21
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	Pulsed Shortwave Therapy	Subjects in this group will receive an active pulsed shortwave therapy device.
Control Group	Pulsed Shortwave Therapy	Subjects in this group will receive a placebo pulsed shortwave device that it does not emit energy.

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index	4 weeks	Quality of life measure for chronic lower back pain

Secondary Outcome Measures

Name	Time	Method
Analgesic Medication use	4 weeks	Quantify the use of analgesic medications
Visual Analogue Pain score	4 weeks	assessment of pain being experienced
The Pain and Sleep Questionnaire three-item index	4 weeks	Assessment of the impact of pain on the subjects sleep

Trial Locations

Locations (1)

North Alabama Primary Care; 🇺🇸 Athens, Alabama, United States