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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
LASER photobiomodulation therapy of 15-25 watts of coherent infrared light to affected area for 10 minutes using wand-type probe.
Sharp Alison DeRose Rehabilitation Center
San Diego, California, United States
Compliance with Medical Opioid Use Reduction Protocol
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.
Time frame: 12 weeks
Self-reported measure of Pain.
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.
Time frame: 12 weeks
Self-reported measure of Quality of Life.
Participants will complete the 36-Item Short Form Health Survey (SF36) at baseline and at study completion.
Time frame: 12 weeks
Self-reported measure of Depression.
Participants will complete the 17-item Hamilton Depression Rating Scale (HAM-D) at baseline and at study completion.
Time frame: 12 weeks
Self-reported measure of Anxiety.
Participants will complete the 40-item State-Trait Anxiety Inventory (STAI) at baseline and at study completion.
Time frame: 12 weeks
Self-reported measure of Sleep Quality.
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Participants will complete the Pittsburgh Sleep Quality Index (PSQI) at baseline and at study completion.
Time frame: 12 weeks
Urine screening
Weekly urine screening will be conducted to assess deviations from treatment (use of non prescribed medications or substances).
Time frame: 12 weeks