Status:
TERMINATED
Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
Lead Sponsor:
LiteCure LLC
Conditions:
Chronic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will examine the effect of LASER photobiomodulation therapy on pain and opioid pain medication weaning on patients who are undergoing opioid pain medication weaning.
Detailed Description
The primary objective of this study is to determine if treatment with LASER photobiomodulation therapy reduces pain and facilitates opioid pain medication (OPM) reduction (weaning). The subject group ...
Eligibility Criteria
Inclusion
- Age 18 or older.
- Taking prescribed opioid pain medications in an amount in excess of 30 Morphine Equivalent Dose (MED) for 6 months or longer.
- Have been recommended to wean or reduce their MED.
- Medically stable such that subject does not have unstable angina, COPD requiring supplemental oxygen, untreated or active cancer or similar conditions that would make participation difficult or unsafe.
- Compliant with all physician recommendations relating to medication usage.
- Ambulatory and able to use the toilet independently.
- Negative pregnancy test in subjects of childbearing potential
- Willing to attempt opioid pain medication taper.
- Competent to provide informed consent.
- Capable of understanding and completing study questionnaires.
- Subject willing to participate in the study for up to 12 weeks.
Exclusion
- Not capable of understanding or completing study questionnaires.
- Lacking capacity to provide fully informed consent.
- Substance use disorder not in remission.
- Considering surgery or other invasive procedures that would take place during the study.
- Used isotretinoin (Accutane) within 6 months prior to study enrollment
- Cancer not in remission.
- Need of ongoing Transcutaneous Electrical Nerve Stimulation (TENS) therapy, massage therapy, chiropractic care or other treatments intended to remediate pain other than treatment in the Sharp Pain Program.
- A female who is pregnant or lactating, or of childbearing potential unless a medically acceptable method of birth control is in use.
- Any use of light-activated drugs (photodynamic therapy) or heat sensitive medications within 30 days of first treatment.
- Used an investigational drug/device therapy or participated in any clinical investigation relating to pain within 4 weeks prior to study enrollment.
- A psychiatric or psychological condition that would place undo stress on the subject, prevent full participation or compromise data collection.
- The subject is otherwise determined, based on the opinion of the Investigator, to be an unsuitable candidate for enrollment in this study
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03437967
Start Date
August 1 2018
End Date
June 1 2019
Last Update
August 26 2019
Active Locations (1)
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1
Sharp Alison DeRose Rehabilitation Center
San Diego, California, United States, 92123