Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning

Not Applicable

Terminated

• Conditions: Chronic Pain
• Interventions: Device: LightForce EXPi

• Registration Number: NCT03437967
• Lead Sponsor: LiteCure LLC

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.

Study Timeline

• Study First Submitted: 2017-12-21
• Study First Submitted QC: 2018-02-15
• Study First Posted: 2018-02-19
• Study Start: 2018-08-01
• Primary Completion: 2019-06-01
• Study Completion: 2019-06-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-21
• Last Update Posted: 2019-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BABA	LightForce EXPi	Treatment, either LASER (arm A) or LOW LEVEL LASER (arm B) will be provided 3 (not less than 2) days a week for three weeks at which time crossover into the alternate arm occurs (BABA to ABAB or ABAB to BABA). BABA initial period is sham treatment - LOW LEVEL LASER. LOW LEVEL LASER "treatment": Low level LASER is provided in a similar fashion using LASER power levels (1 Watt) that produce warmth only at superficial skin levels.
ABAB	LightForce EXPi	Treatment, either LASER (arm A) or LOW LEVEL LASER (arm B) will be provided 3 (not less than 2) days a week for three weeks at which time crossover into the alternate arm occurs (BABA to ABAB or ABAB to BABA). ABAB initial period is active treatment - LASER. Active Treatment: LASER light is delivered to the skin and deeper tissues affected by pain using either a wand or glass roller ball. Ten to 25 Watts of LASER energy is delivered to the painful regions for 8 to 16 minutes depending on the size of the area treated and other factors such as skin pigmentation.

Primary Outcome Measures

Name	Time	Method
Compliance with Medical Opioid Use Reduction Protocol	12 weeks	Prescriptions for pain medications will be provided each week. Each successive prescription will have a decreasing quantity of tablets consistent with an agreed upon taper rate. Taper rates will be roughly based upon the recommendations of the CDC (10% per week). Subjects will have the option of postponing the taper by one week as often as every other week. If a subject was to exercise every option available to them to delay taper, then the weaning process would take twice as long and the rate of taper would be cut in half.; The study will compare the number of missed medication tapers, and the taper rates of patients in the HIGH POWER LASER treatment periods to those in the LOW LEVEL LASER THERAPY treatment periods.

Secondary Outcome Measures

Name	Time	Method
Self-reported measure of Anxiety.	12 weeks	Participants will complete the 40-item State-Trait Anxiety Inventory (STAI) at baseline and at study completion.
Self-reported measure of Quality of Life.	12 weeks	Participants will complete the 36-Item Short Form Health Survey (SF36) at baseline and at study completion.
Self-reported measure of Depression.	12 weeks	Participants will complete the 17-item Hamilton Depression Rating Scale (HAM-D) at baseline and at study completion.
Self-reported measure of Sleep Quality.	12 weeks	Participants will complete the Pittsburgh Sleep Quality Index (PSQI) at baseline and at study completion.
Urine screening	12 weeks	Weekly urine screening will be conducted to assess deviations from treatment (use of non prescribed medications or substances).
Self-reported measure of Pain.	12 weeks	Participants will complete the Visual Analogue Scale for Pain (Wong Baker FACES pain rating scale), taken at baseline, weekly thereafter, and immediately after the last treatment.

Trial Locations

Locations (1)

Sharp Alison DeRose Rehabilitation Center; 🇺🇸 San Diego, California, United States