Chronic PainNCT03437967
Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
A study testing LightForce EXPi in people with Chronic Pain, run by LiteCure LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain
- What is being tested?
- LightForce EXPi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Sharp Alison DeRose Rehabilitation Center
San Diego, California, 92123
About this study
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.
Read the 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
- Being tested
- LightForce EXPi
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LightForce EXPiDevice
Also called LASER photobiomodulation therapy, LASER therapy
LASER photobiomodulation therapy of 15-25 watts of coherent infrared light to affected area for 10 minutes using wand-type probe.
| Study group | Role | What they receive |
|---|---|---|
| ABAB | Other | 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. Receives: Device: LightForce EXPi |
| BABA | Other | 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. Receives: Device: LightForce EXPi |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Self-reported measure of Anxiety.
Participants will complete the 40-item State-Trait Anxiety Inventory (STAI) at baseline and at study completion.
Measured: 12 weeks
Self-reported measure of Sleep Quality.
Participants will complete the Pittsburgh Sleep Quality Index (PSQI) at baseline and at study completion.
Measured: 12 weeks
Urine screening
Weekly urine screening will be conducted to assess deviations from treatment (use of non prescribed medications or substances).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Aug 2018
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Why it stopped: Patient withdrawal symptoms unblinded the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- LiteCure LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jerome C Stenehjem, Md, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437967
- Sponsor's protocol ID
- PBMT for Chronic Pain
- Status last verified
- Aug 2019
- First submitted
- 21 Dec 2017
- Last updated
- 26 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: There is no intent to share data and no plan formulated at this time.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning
- ClinicalTrials.gov ID
- NCT03437967
- Acronym / sponsor ID
- PBMT for Chronic Pain
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient withdrawal symptoms unblinded the study
- Enrolment
- 12 participants (actual)
- Lead sponsor
- LiteCure LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 19 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ABAB | Other | Device: LightForce EXPiTreatment, 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. |
| BABA | Other | Device: LightForce EXPiTreatment, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LightForce EXPiAlso: LASER photobiomodulation therapy, LASER therapyLASER photobiomodulation therapy of 15-25 watts of coherent infrared light to affected area for 10 minutes using wand-type probe. | Device | ABAB, BABA |
Primary outcome
Compliance with Medical Opioid Use Reduction Protocol
Time frame: 12 weeks
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.
6 secondary outcomes
Self-reported measure of Pain.
Time frame: 12 weeks
Self-reported measure of Quality of Life.
Time frame: 12 weeks
Self-reported measure of Depression.
Time frame: 12 weeks
Self-reported measure of Anxiety.
Time frame: 12 weeks
Self-reported measure of Sleep Quality.
Time frame: 12 weeks
Urine screening
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Patient withdrawal symptoms unblinded the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Individual participant dataSharing planned: Undecided. There is no intent to share data and no plan formulated at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jerome C Stenehjem, Md principal investigator
Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LightForce EXPi in people with Chronic Pain, run by LiteCure LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Patient withdrawal symptoms unblinded the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with Medical Opioid Use Reduction Protocol (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2019.