An interventional study of Sham low level laser and Active low level laser in Chronic Pain, sponsored by University of Texas Southwestern Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-07.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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:
A. 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.
B. 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.
C. 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.
493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.
This study's enrollment of 11 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.
Browse Musculoskeletal Pain studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Physical therapy specific inclusion for acceptance to the pain program (and this study) include:
Exclusion Criteria:
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.
Device: Sham low level laser
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.
Device: Active low level laser
Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
Active treatment will be delivered using the time, contact, and energy exposures described in the arm description.
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.
Time frame: Baseline, 4 week, 8 week
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 4 week, 8 week
| Milestone | Sham Low Level Laser | Active Low Level Laser |
|---|---|---|
| Started | 4 | 7 |
| Completed | 4 | 7 |
| Not completed | 0 | 0 |
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.
| score on a scale | Sham Low Level Laser | Active Low Level Laser |
|---|---|---|
| Baseline | 4 ± 1.2 | 3.7 ± 0.96 |
| 4 week | 6.1 ± 2.0 | 4.1 ± 1.2 |
| 8 week | 4.04 ± 1.4 | 3.6 ± 0.95 |
Valid and reliable 11 item assessment of kinesiophobia. Scores range from 11-44, with higher scores indicating greater degrees of kinesiophobia.
| score on a scale | Sham Low Level Laser | Active Low Level Laser |
|---|---|---|
| Baseline | 33 ± 1.1 | 27.5 ± 3.8 |
| 4 week | 31 ± 8.2 | 28.1 ± 6.5 |
| 8 week | 20.2 ± 9.2 | 22 ± 3.5 |
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.
| score on a scale | Sham Low Level Laser | Active Low Level Laser |
|---|---|---|
| Baseline | 9.75 ± 3.8 | 9.25 ± 5.2 |
| 4 week | 11.5 ± 6.1 | 9 ± 4.5 |
| 8 week | 9.75 ± 5.2 | 8 ± 4 |
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.
| score on a scale | Sham Low Level Laser | Active Low Level Laser |
|---|---|---|
| Baseline | 11.5 ± 9.1 | 11.8 ± 3.5 |
| 4 week | 11.5 ± 9.1 | 9.7 ± 4.6 |
| 8 week | 13.8 ± 4.2 | 13.7 ± 5.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sham Low Level Laser | — | 0/4 (0%) | 0/4 (0%) |
| Active Low Level Laser | — | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | Sham Low Level Laser | Active Low Level Laser | Total |
|---|---|---|---|
| Mean | 56 ± 15.1 | 64.6 ± 15.8 | 60.3 ± 15.3 |
| Sex: Female, Male(Participants) | Sham Low Level Laser | Active Low Level Laser | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 1 | 4 | 5 |
| Region of Enrollment(participants) | Sham Low Level Laser | Active Low Level Laser | Total |
|---|---|---|---|
| United States | 4 | 7 | 11 |
| Numeric Pain Rating Scale (NPRS)(units on a scale) | Sham Low Level Laser | Active Low Level Laser | Total |
|---|---|---|---|
| Mean | 4.0 ± 1.2 | 3.7 ± 0.96 | 3.9 ± 1.1 |
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University of Texas Southwestern Medical Center