ClinicalTrials.gg
TerminatedNCT03437967Updated Aug 26, 2019

Effect of LASER Photobiomodulation Therapy on Chronic Pain and Opioid Weaning

An interventional study of LightForce EXPi in Chronic Pain, sponsored by LiteCure LLC. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-26.

Sponsored by LiteCure LLC (part of Enovis) · Not applicable, Interventional, and Treatment

Why this study was terminated
Patient withdrawal symptoms unblinded the study

From the registry’s dates

  • Primary completion was Jun 2019, 7 years 5 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,283 studies in Chronic Pain with a site in United States — 258 open to participants now, 349 under way, 8 of them phase 3. Chronic Pain · United States.

Enrollment
954th of 1,092
12 · median 60
Started
2018
with 90 others
No phase
802 of 1,283
168 open now
Registered
429th of 1,283
by date

Among the 1,283 studies in Chronic Pain with a site in United States, this one is the 954th largest by enrollment of the 1,092 interventional ones that give a count, is one of 91 that started in 2018, is one of 802 with no phase, and was the 429th registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

258 of the 1,283 studies in Chronic Pain with a site in United States are open now. Recruiting first, the newest first:

253 more — sign in →

All 258 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,283 studies in Chronic Pain with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Chronic Pain

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, 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
  • Willing to attempt opioid pain medication taper.
  • Competent to provide .
  • Capable of understanding and completing study questionnaires.
  • Subject willing to participate in the study for up to 12 weeks.

Exclusion criteria

Exclusion Criteria:

  • Not capable of understanding or completing study questionnaires.
  • Lacking capacity to provide fully .
  • 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 unless a medically acceptable method of is in use.
  • Any use of light-activated drugs (photodynamic therapy) or heat sensitive medications within 30 days of first treatment.
  • Used an 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
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Other
    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.

    Device: LightForce EXPi

  • Other
    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.

    Device: LightForce EXPi

Interventions

  • DeviceLightForce EXPi

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

    Also known as: LASER photobiomodulation therapy, LASER therapy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. Self-reported measure of Quality of Life.

    Participants will complete the 36-Item Short Form Health Survey (SF36) at baseline and at study completion.

    Time frame: 12 weeks

  3. Self-reported measure of Depression.

    Participants will complete the 17-item Hamilton Depression Rating Scale (HAM-D) at baseline and at study completion.

    Time frame: 12 weeks

  4. Self-reported measure of Anxiety.

    Participants will complete the 40-item State-Trait Anxiety Inventory (STAI) at baseline and at study completion.

    Time frame: 12 weeks

  5. Self-reported measure of Sleep Quality.

    Participants will complete the Pittsburgh Sleep Quality Index (PSQI) at baseline and at study completion.

    Time frame: 12 weeks

  6. Urine screening

    Weekly urine screening will be conducted to assess deviations from treatment (use of non prescribed medications or substances).

    Time frame: 12 weeks

07

Study locations

1 site
  • Sharp Alison DeRose Rehabilitation Center
    San Diego, California 92123, United States
08

References and documents

Individual participant data

Plan to share: Undecided — There is no intent to share data and no plan formulated at this time.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2018 to primary completion in Jun 2019, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 21, 2017
First posted
Feb 19, 2018
StartActual
Aug 1, 2018
Primary completionActual
Jun 1, 2019
CompletionActual
Jun 1, 2019
Last update
Aug 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03437967
Lead sponsor
LiteCure LLC
Responsible party
Sponsor
First posted
Feb 19, 2018
Start date
Aug 1, 2018
Primary completion
Jun 1, 2019
Completion
Jun 1, 2019
Last update
Aug 26, 2019

Study contacts

Jerome C Stenehjem, Md
principal investigator · Sharp HealthCare

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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