Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning

LiteCure

Status: Terminated

Conditions: Chronic Pain

Treatments: Device: LightForce EXPi

Study type: Interventional

Funder types: Industry

Identifiers

NCT03437967

PBMT for Chronic Pain

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

ABAB

Other group

Description:

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.

Treatment:

Device: LightForce EXPi

BABA

Other group

Description:

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.

Treatment:

Device: LightForce EXPi