Clinical trial NCT03437967: Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
Official title: Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: LiteCure LLC
Sponsor class: INDUSTRY
First posted: 2018-02-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a prospective interventional study using a double-blind 4-period crossover design to assess the efficacy of LASER Photobiomodulation therapy compared to sham (LOW POWER LASER) therapy in reducing pain and improving compliance with OPM weaning. LASER photobiomodulation treatments or sham treatments will be provided three times a week using standardized protocols. Crossover will occur every 3 weeks with weekly data collection occurring at the end of each week allowing for washout and to minimize the carryover effects of active treatment. Data collection will consist of LASER and sham treatments, prescribed pain medication dosage and quantity, subjective pain questionnaires, and urine samples. Cognitive and memory screening will occur every 3 weeks at the end of each period prior to crossover.
Primary purpose: TREATMENT

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 includes patients with chronic pain who are undergoing OPM weaning and are candidates for LASER photobiomodulation therapy. This is a prospective interventional study using a double-blind 4-period crossover design to assess the efficacy of HIGH POWER LASER photobiomodulation therapy compared to sham (LOW POWER LASER) therapy in reducing pain and improving compliance with OPM weaning.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Compliance with Medical Opioid Use Reduction Protocol
timeFrame: 12 weeks
Secondary outcomes:
measure: Self-reported measure of Pain.
timeFrame: 12 weeks
measure: Self-reported measure of Quality of Life.
timeFrame: 12 weeks
measure: Self-reported measure of Depression.
timeFrame: 12 weeks
measure: Self-reported measure of Anxiety.
timeFrame: 12 weeks
measure: Self-reported measure of Sleep Quality.
timeFrame: 12 weeks
measure: Urine screening
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Alison DeRose Rehabilitation Center
state: California
Study officials:
affiliation: Sharp HealthCare
name: Jerome C Stenehjem, Md
role: PRINCIPAL_INVESTIGATOR
References: