Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning

NCT ID: NCT03437967

Last Updated: 2019-08-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2019-06-01

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ABAB

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.

Group Type: OTHER

LightForce EXPi

Intervention Type: DEVICE

LASER photobiomodulation therapy of 15-25 watts of coherent infrared light to affected area for 10 minutes using wand-type probe.

BABA

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.

Group Type: OTHER

LightForce EXPi

Intervention Type: DEVICE

LASER photobiomodulation therapy of 15-25 watts of coherent infrared light to affected area for 10 minutes using wand-type probe.

Interventions

LightForce EXPi

LASER photobiomodulation therapy of 15-25 watts of coherent infrared light to affected area for 10 minutes using wand-type probe.

Intervention Type: DEVICE

Other Intervention Names

LASER photobiomodulation therapy; LASER therapy

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LiteCure LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jerome C Stenehjem, Md

Role: PRINCIPAL_INVESTIGATOR

Sharp HealthCare

Locations

Sharp Alison DeRose Rehabilitation Center

San Diego, California, United States

Countries

United States

Other Identifiers

PBMT for Chronic Pain

Identifier Type: -

Identifier Source: org_study_id