Not provided
Not provided
Not provided
Not provided
Not provided
Difficulty controlling for confounding factors
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sham low level laser | Device | Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 week, 8 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 4 week, 8 week |
| Pittsburgh Sleep Quality Index |
Not provided
Inclusion Criteria:
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.
Able to give informed consent.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ross Querry, PT, PhD | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McDermott Pain Management Clinic | Dallas | Texas | 75390 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. Sham 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. |
| FG001 | Active 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. Areas for application and contact will otherwise be consistent with the sham group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. Sham 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 week, 8 week |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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. Sham 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Zafereo | UT Southwestern | 146481002 | 146481002 | jason.zafereo@utsouthwestern.edu |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Active low level laser | Device | Active treatment will be delivered using the time, contact, and energy exposures described in the arm description. |
|
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.
| 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. | Baseline, 4 week, 8 week |
| BG001 | Active 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. Active low level laser: Active treatment will be delivered using the time, contact, and energy exposures described in the arm description. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Numeric Pain Rating Scale (NPRS) | Perceived pain on scale of 0-10 (0=no pain, 10= extremely severe pain). | Mean | Standard Deviation | units on a scale |
|
| OG001 | Active 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. Areas for application and contact will otherwise be consistent with the sham group. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 week, 8 week |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 week, 8 week |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 4 week, 8 week |
|
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Active 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. Areas for application and contact will otherwise be consistent with the sham group. | 0 | 7 | 0 | 7 |
Not provided
Not provided
Not provided
| 8 week |
|
| 8 week |
|
| 8 week |
|