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

This study is currently recruiting participants.
Verified November 2017 by BioElectronics Corporation
Sponsor:
ClinicalTrials.gov Identifier:
NCT03240146
First Posted: August 4, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
BioElectronics Corporation
  Purpose
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 Intervention
Chronic Low Back Pain Device: Pulsed Shortwave Therapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by BioElectronics Corporation:

Primary Outcome Measures:
  • Oswestry Disability Index [ Time Frame: 4 weeks ]
    Quality of life measure for chronic lower back pain


Secondary Outcome Measures:
  • Visual Analogue Pain score [ Time Frame: 4 weeks ]
    assessment of pain being experienced

  • The Pain and Sleep Questionnaire three-item index [ Time Frame: 4 weeks ]
    Assessment of the impact of pain on the subjects sleep

  • Analgesic Medication use [ Time Frame: 4 weeks ]
    Quantify the use of analgesic medications


Estimated Enrollment: 60
Actual Study Start Date: September 28, 2017
Estimated Study Completion Date: December 15, 2017
Estimated Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240146


Contacts
Contact: Chandra Koneru, MD 256-777-1111 ckoneru@yahoo.com
Contact: Sree Koneru, Ph.d 301-874-6738 ext 106 skoneru@bielcorp.com

Locations
United States, Alabama
North Alabama Primary Care Recruiting
Athens, Alabama, United States, 35611
Contact: Chandra Koneru, MD    256-232-2505      
Sponsors and Collaborators
BioElectronics Corporation
Investigators
Principal Investigator: Chandra Koneru, MD North Alabama Primary Care
  More Information

Responsible Party: BioElectronics Corporation
ClinicalTrials.gov Identifier: NCT03240146     History of Changes
Other Study ID Numbers: SAIRB-17-0057
First Submitted: August 2, 2017
First Posted: August 4, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms