Chronic PainNCT02785432
Low Level Laser Therapy With Physical Therapy for Chronic Musculoskeletal Pain
A study testing Active low level laser in people with Chronic Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
1. Examine the use of low level therapeutic laser (LLLT) combined with physical therapy for improvements in pain, range of motion, and function in individuals with chronic pain from musculoskeletal conditions. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Active low level laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- Primary referral and acceptance to the UTSW McDermott Multidisciplinary Pain Management Program. All diagnoses will be included.
- Physical therapy specific inclusion for acceptance to the pain program (and this study) include:
- Musculoskeletal pain greater than 3 months
- Pain upon palpation or with movement of the extremities
- Medically cleared for physical therapy (exercise) in terms of cardiac, orthopedic, neurological impairments.
Show all 9Show fewer
- Cognitive, verbal, and physical abilities to self-detect and report pain and changes in exercise effort.
- Ability to speak English and follow exercise based instructions.
- Able to give informed consent.
Who cannot join
- Inability to meet inclusion criteria for pain program
- Current use of photosensitive medication (has been instructed to minimize sun exposure)
- Active metastasis
- Active infection
- Diagnoses that exclude PT including cauda equine syndrome, myopathy, acute fracture (8-weeks).
- Impaired sensation
Trial locations and contacts
1 site in 1 country.
United States1 site
McDermott Pain Management Clinic
Dallas, Texas, 75390
About this study
Official title: The Use of Low Level Laser Therapy With Physical Therapy for Pain and Improved Function in Individuals With Chronic Musculoskeletal Pain
- Examine the use of low level therapeutic laser (LLLT) combined with physical therapy for improvements in pain, range of motion, and function in individuals with chronic pain from musculoskeletal conditions.
- Compare changes in pain, mobility, and ability to return to home/work/recreational activities between treatments with standard physical therapy plus LLLT or the standard physical therapy program alone.
Read the detailed description
Potential subjects will be identified by their physician referral to the pain program and after initial evaluation by the medical personnel and physical therapy for appropriate inclusion in the pain program. For individuals who meet entry parameters for the pain program, this project will be discussed by their physical therapist for consideration of voluntary participation. If participants are willing to participate, appropriate consent and HIPPA permissions will be obtained.
After consent, the patient will be randomized to one of the two treatment cohorts which consists of utilizing either laser or sham laser before and during pain program participation. The principle investigator will be blinded to the treatment allocation group. The treating clinician will be aware of their treatment allocation assignment for laser application. Each treatment cohort will be completed as assigned. Physical therapy treatment in addition to the study intervention will be selected by the treating clinician based on participant's specific needs as standard of care would dictate. Outcome measures will be collected as described below.
Testing Schedule:
The assigned study intervention (LLLT or Sham) will be administered on each of the clinical visits for phase 1 and 2 of the study. Outcome measures will be completed on the following schedule.
Phase 1: Conducted during the period between acceptance to pain program and start the of the pain program (4 weeks). Baseline testing will be completed at the time of initial evaluation and enrollment to the study.
Phase 1 final testing (4 weeks) will be on the first clinic visit of the formal pain program. Phase 2: This phase is the 4-week formal pain program (2 visits/week x 4 weeks, total 8 visits). Final testing (8 weeks) will be on the final visit of the formal pain program.
Measurements:
- Numerical pain rating scale (NPRS): perceived pain on scale of 0-10 (0=no pain, 10= extremely severe pain). Pain during the previous 24-hour period (best, worst, current) will be measured at baseline, 4 weeks, and 8 weeks. The average of 3 scores will be used.
- Region specific functional outcome measure: A valid and reliable outcome tool of broad based physical function based on the body region of interest will be completed. Measured at baseline, 4 weeks, and 8 weeks.
- Questionnaires of fear avoidance (FABQ, or TKS) and sleep quality (Pittsburg sleep index) will be taken as measures of quality of life and impact. Measures will be taken at baseline, 4 weeks, and 8 weeks.
All procedures, measurements, and interventions (exercises) are considered to be standard of care for rehabilitation and the subject's needs. The experimental aspect of the study is derived from the randomized selection of which laser intervention will be utilized before and during program participation.
- Conditions
- Chronic Pain
- Being tested
- Sham low level laser, Active low level laser
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham low level laserDevice
Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
Active low level laserDevice
Active treatment will be delivered using the time, contact, and energy exposures described in the arm description.
| Study group | Role | What they receive |
|---|---|---|
| Sham low level laser | Sham comparator | Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized. Receives: Device: Sham low level laser |
| Active low level laser | Active comparator | Treatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Areas for administration and contact will otherwise be consistent with the sham group. Receives: Device: Active low level laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Perceived pain on scale of 0-10 (0=no pain, 10= extremely severe pain). Pain during the previous 24-hour period (best, worst, current) will be measured at T1-T8. The average of 3 scores will be used.
Measured: Baseline, 4 week, 8 week
Secondary outcomes (3)
Tampa Scale of Kinesiophobia
Valid and reliable 11 item assessment of kinesiophobia. Scores range from 11-44, with higher scores indicating greater degrees of kinesiophobia.
Measured: Baseline, 4 week, 8 week
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
The sum of scores for these seven components yields one global score. each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
Measured: Baseline, 4 week, 8 week
Patient Specific Functional Scale
Valid and reliable measure of the degree of difficulty with 3 self-selected activities as rated on an 11 point scale. The scores for the three activities are summed to create a total score ranging from 0-30, with higher scores indicating better/normal function.
Measured: Baseline, 4 week, 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Difficulty controlling for confounding factors
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ross Querry, University of Texas Southwestern Medical Center
- Investigators
- Ross Querry, PT, PhD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785432
- Sponsor's protocol ID
- STU 012016-003
- Status last verified
- Jun 2020
- First submitted
- 20 May 2016
- Last updated
- 7 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Low Level Laser Therapy With Physical Therapy for Pain and Improved Function in Individuals With Chronic Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT02785432
- Acronym / sponsor ID
- STU 012016-003
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty controlling for confounding factors
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Examine the use of low level therapeutic laser (LLLT) combined with physical therapy for improvements in pain, range of motion, and function in individuals with chronic pain from musculoskeletal conditions.
- Compare changes in pain, mobility, and ability to return to home/work/recreational activities between treatments with standard physical therapy plus LLLT or the standard physical therapy program alone.
Detailed description
Potential subjects will be identified by their physician referral to the pain program and after initial evaluation by the medical personnel and physical therapy for appropriate inclusion in the pain program. For individuals who meet entry parameters for the pain program, this project will be discussed by their physical therapist for consideration of voluntary participation. If participants are willing to participate, appropriate consent and HIPPA permissions will be obtained.
After consent, the patient will be randomized to one of the two treatment cohorts which consists of utilizing either laser or sham laser before and during pain program participation. The principle investigator will be blinded to the treatment allocation group. The treating clinician will be aware of their treatment allocation assignment for laser application. Each treatment cohort will be completed as assigned. Physical therapy treatment in addition to the study intervention will be selected by the treating clinician based on participant's specific needs as standard of care would dictate. Outcome measures will be collected as described below.
Testing Schedule:
The assigned study intervention (LLLT or Sham) will be administered on each of the clinical visits for phase 1 and 2 of the study. Outcome measures will be completed on the following schedule.
Phase 1: Conducted during the period between acceptance to pain program and start the of the pain program (4 weeks). Baseline testing will be completed at the time of initial evaluation and enrollment to the study.
Phase 1 final testing (4 weeks) will be on the first clinic visit of the formal pain program. Phase 2: This phase is the 4-week formal pain program (2 visits/week x 4 weeks, total 8 visits). Final testing (8 weeks) will be on the final visit of the formal pain program.
Measurements:
- Numerical pain rating scale (NPRS): perceived pain on scale of 0-10 (0=no pain, 10= extremely severe pain). Pain during the previous 24-hour period (best, worst, current) will be measured at baseline, 4 weeks, and 8 weeks. The average of 3 scores will be used.
- Region specific functional outcome measure: A valid and reliable outcome tool of broad based physical function based on the body region of interest will be completed. Measured at baseline, 4 weeks, and 8 weeks.
- Questionnaires of fear avoidance (FABQ, or TKS) and sleep quality (Pittsburg sleep index) will be taken as measures of quality of life and impact. Measures will be taken at baseline, 4 weeks, and 8 weeks.
All procedures, measurements, and interventions (exercises) are considered to be standard of care for rehabilitation and the subject's needs. The experimental aspect of the study is derived from the randomized selection of which laser intervention will be utilized before and during program participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham low level laser | Sham comparator | Device: Sham low level laserTreatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 0 watts for a total of 0 joules based on body surface area treated. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Area for administration will include 6 minutes of application along spine (C2-S1), and 4 minutes of application either to bilateral upper extremity or bilateral lower extremity based on areas of primary pain complaint. The contact head applicator will be used if soft tissue contact is tolerable. Otherwise, the non-contact head will be utilized. |
| Active low level laser | Active comparator | Device: Active low level laserTreatment will be administered 2x/w x 4 weeks as a standalone, then 2 times/week x 4 weeks in conjunction with standard physical therapy and counseling. The clinician will apply 10 minutes of low level laser therapy at a dosage of 15-25 watts for a total of 9,000-15,000 joules based on body surface area treated. This equates to standard acceptable dosing of 6-10 j/cm2 over the larger area of treatment. Application will be with light to moderate contact pressure based on patient tolerance (should be no additional discomfort from laser). Areas for administration and contact will otherwise be consistent with the sham group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18-80 years old
- Primary referral and acceptance to the UTSW McDermott Multidisciplinary Pain Management Program. All diagnoses will be included.
- Physical therapy specific inclusion for acceptance to the pain program (and this study) include:
- Cognitive, verbal, and physical abilities to self-detect and report pain and changes in exercise effort.
- Ability to speak English and follow exercise based instructions.
Key exclusion criteria (6 listed)
- Inability to meet inclusion criteria for pain program
- Current use of photosensitive medication (has been instructed to minimize sun exposure)
- Active metastasis
- Active infection
- Diagnoses that exclude PT including cauda equine syndrome, myopathy, acute fracture (8-weeks).
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 |
|---|---|---|
| Sham low level laserSham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered. | Device | Sham low level laser |
| Active low level laserActive treatment will be delivered using the time, contact, and energy exposures described in the arm description. | Device | Active low level laser |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline, 4 week, 8 week
Perceived pain on scale of 0-10 (0=no pain, 10= extremely severe pain). Pain during the previous 24-hour period (best, worst, current) will be measured at T1-T8. The average of 3 scores will be used.
3 secondary outcomes
Tampa Scale of Kinesiophobia
Time frame: Baseline, 4 week, 8 week
Pittsburgh Sleep Quality Index
Time frame: Baseline, 4 week, 8 week
Patient Specific Functional Scale
Time frame: Baseline, 4 week, 8 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ross Querry, PT, PhD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active low level laser in people with Chronic Pain, run by University of Texas Southwestern Medical Center 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 9 inclusion and 6 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 7 Jul 2020. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numeric Pain Rating Scale (NPRS) (time frame: Baseline, 4 week, 8 week). 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 7 Jul 2020.