Back to resultsEffect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
Primary Purpose
Chronic Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LightForce EXPi
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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
Sites / Locations
- Sharp Alison DeRose Rehabilitation Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
ABAB
BABA
Arm 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, 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Self-reported measure of Quality of Life.
Participants will complete the 36-Item Short Form Health Survey (SF36) at baseline and at study completion.
Self-reported measure of Depression.
Participants will complete the 17-item Hamilton Depression Rating Scale (HAM-D) at baseline and at study completion.
Self-reported measure of Anxiety.
Participants will complete the 40-item State-Trait Anxiety Inventory (STAI) at baseline and at study completion.
Self-reported measure of Sleep Quality.
Participants will complete the Pittsburgh Sleep Quality Index (PSQI) at baseline and at study completion.
Urine screening
Weekly urine screening will be conducted to assess deviations from treatment (use of non prescribed medications or substances).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03437967
Brief Title
Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
Official Title
Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Patient withdrawal symptoms unblinded the study
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LiteCure LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a prospective interventional study using a double-blind 4-period crossover design to assess the efficacy of LASER Photobiomodulation therapy compared to sham (LOW POWER LASER) therapy in reducing pain and improving compliance with OPM weaning. LASER photobiomodulation treatments or sham treatments will be provided three times a week using standardized protocols. Crossover will occur every 3 weeks with weekly data collection occurring at the end of each week allowing for washout and to minimize the carryover effects of active treatment. Data collection will consist of LASER and sham treatments, prescribed pain medication dosage and quantity, subjective pain questionnaires, and urine samples. Cognitive and memory screening will occur every 3 weeks at the end of each period prior to crossover.
Masking
ParticipantOutcomes Assessor
Masking Description
Sham therapy will consist of treatment using an identically appearing device that delivers low level LASER POWER to simulate LASER treatment.
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABAB
Arm Type
Other
Arm 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.
Arm Title
BABA
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
LightForce EXPi
Other Intervention Name(s)
LASER photobiomodulation therapy, LASER therapy
Intervention Description
LASER photobiomodulation therapy of 15-25 watts of coherent infrared light to affected area for 10 minutes using wand-type probe.
Primary Outcome Measure Information:
Title
Compliance with Medical Opioid Use Reduction Protocol
Description
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
Secondary Outcome Measure Information:
Title
Self-reported measure of Pain.
Description
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
Title
Self-reported measure of Quality of Life.
Description
Participants will complete the 36-Item Short Form Health Survey (SF36) at baseline and at study completion.
Time Frame
12 weeks
Title
Self-reported measure of Depression.
Description
Participants will complete the 17-item Hamilton Depression Rating Scale (HAM-D) at baseline and at study completion.
Time Frame
12 weeks
Title
Self-reported measure of Anxiety.
Description
Participants will complete the 40-item State-Trait Anxiety Inventory (STAI) at baseline and at study completion.
Time Frame
12 weeks
Title
Self-reported measure of Sleep Quality.
Description
Participants will complete the Pittsburgh Sleep Quality Index (PSQI) at baseline and at study completion.
Time Frame
12 weeks
Title
Urine screening
Description
Weekly urine screening will be conducted to assess deviations from treatment (use of non prescribed medications or substances).
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome C Stenehjem, Md
Organizational Affiliation
Sharp HealthCare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sharp Alison DeRose Rehabilitation Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
There is no intent to share data and no plan formulated at this time.
Learn more about this trial
Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
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