Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid 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.

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