Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain

NCT03240146 | Completed FDA Device

• 1 other identifier: SAIRB-17-0057
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index

  Quality of life measure for chronic lower back pain

  4 weeks

Secondary Outcomes (3)

• Visual Analogue Pain score

  4 weeks

• The Pain and Sleep Questionnaire three-item index

  4 weeks

• Analgesic Medication use

  4 weeks

Study Arms (2)

Study Group

ACTIVE COMPARATOR

Subjects in this group will receive an active pulsed shortwave therapy device.

Device: Pulsed Shortwave Therapy

Control Group

PLACEBO COMPARATOR

Subjects in this group will receive a placebo pulsed shortwave device that it does not emit energy.

Device: Pulsed Shortwave Therapy

Interventions

Pulsed Shortwave Therapy DEVICE

Pulsed Shortwave Therapy device

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• able to complete and tolerate treatment for the study period.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioElectronics Corporation: lead

Study Sites (1)

North Alabama Primary Care

Athens, Alabama, 35611, United States

Location

Study Officials

• Chandra Koneru, MD

  North Alabama Primary Care

  PRINCIPAL INVESTIGATOR

• Sree Koneru, Ph.D

  BioElectronics Corporation

  STUDY DIRECTOR

• Ian Rawe, Ph.D.

  BioElectronics Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Devices will be coded, the placebo device is Identical to the active device in all ways except emitting the electromagnetic field. The energy emitted causes no sensation so can not be unmasked by user.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 4, 2017
• Study Start: September 28, 2017
• Primary Completion: December 21, 2017
• Study Completion: December 21, 2017
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)