- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03240146
Pulsed Shortwave Therapy Treatment for Chronic Musculoskeletal Low Back Pain (PSWT)
Pulsed Shortwave Therapy (PSWT) Treatment for Chronic Musculoskeletal Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Athens, Alabama, United States, 35611
- North Alabama Primary Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Study Group
Subjects in this group will receive an active pulsed shortwave therapy device.
|
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.
|
Pulsed Shortwave Therapy device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Oswestry Disability Index
Time Frame: 4 weeks
|
Quality of life measure for chronic lower back pain
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Pain score
Time Frame: 4 weeks
|
assessment of pain being experienced
|
4 weeks
|
The Pain and Sleep Questionnaire three-item index
Time Frame: 4 weeks
|
Assessment of the impact of pain on the subjects sleep
|
4 weeks
|
Analgesic Medication use
Time Frame: 4 weeks
|
Quantify the use of analgesic medications
|
4 weeks
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAIRB-17-0057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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