Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT02785432
Status:
TERMINATED
Last Update Posted:
2020-07-07
First Post:
2016-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Low Level Laser Therapy With Physical Therapy for Chronic Musculoskeletal Pain
Sponsor:
University of Texas Southwestern Medical Center
Organization:
Study Overview
Official Title:
The Use of Low Level Laser Therapy With Physical Therapy for Pain and Improved Function in Individuals With Chronic Musculoskeletal Pain
Status:
TERMINATED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Difficulty controlling for confounding factors
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
2. 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:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: