Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain (PSWT)

• ClinicalTrials.gov Identifier: NCT03240146
• Recruitment Status: Completed
• First Posted: August 4, 2017
• Last Update Posted: August 2, 2018
• Sponsor: BioElectronics Corporation
• Information provided by (Responsible Party): BioElectronics Corporation

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Low Back Pain	Device: Pulsed Shortwave Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Other
• Official Title: Pulsed Shortwave Therapy (PSWT) Treatment for Chronic Musculoskeletal Low Back Pain
• Actual Study Start Date: September 28, 2017
• Actual Primary Completion Date: December 21, 2017
• Actual Study Completion Date: December 21, 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Study Group; Subjects in this group will receive an active pulsed shortwave therapy device.	Device: Pulsed Shortwave Therapy; Pulsed Shortwave Therapy device
Placebo Comparator: Control Group; Subjects in this group will receive a placebo pulsed shortwave device that it does not emit energy.	Device: Pulsed Shortwave Therapy; Pulsed Shortwave Therapy device

Outcome Measures

Primary Outcome Measures :

1. Oswestry Disability Index [ Time Frame: 4 weeks ]
   Quality of life measure for chronic lower back pain

Secondary Outcome Measures :

1. Visual Analogue Pain score [ Time Frame: 4 weeks ]
   assessment of pain being experienced
2. The Pain and Sleep Questionnaire three-item index [ Time Frame: 4 weeks ]
   Assessment of the impact of pain on the subjects sleep
3. Analgesic Medication use [ Time Frame: 4 weeks ]
   Quantify the use of analgesic medications

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Alabama

North Alabama Primary Care

Athens, Alabama, United States, 35611

Sponsors and Collaborators

BioElectronics Corporation

Investigators

• Principal Investigator: Chandra Koneru, MD; North Alabama Primary Care
• Study Director: Sree Koneru, Ph.D; BioElectronics Corporation
• Study Chair: Ian Rawe, Ph.D.; BioElectronics Corporation

More Information

• Responsible Party: BioElectronics Corporation
• ClinicalTrials.gov Identifier: NCT03240146
• Other Study ID Numbers: SAIRB-17-0057
• First Posted: August 4, 2017
• Last Update Posted: August 2, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Back Pain; Low Back Pain; Pain; Neurologic Manifestations