Low Level Laser Therapy With Physical Therapy for Chronic Musculoskeletal Pain

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 (2-4 weeks). Baseline testing pre (T1) will be completed at the time of initial
evaluation and enrollment to the study.

A. Follow-up testing post (T2 a, b, c) will be completed weekly during this phase.

B. Phase 1 final testing (T3) will be on the first clinic visit of the formal pain program.
The last testing period of phase 1 will also serve as baseline for Phase 2.

Phase 2: This phase is the 4-week formal pain program (2 visits/week x 4 weeks, total 8
visits). Baseline testing (T3) will be on the first clinic visit of the formal pain program.

C. Follow-up testing post (T4-T7) will be completed weekly during phase 2. D. Following
completion of the pain program. Follow up measurements will be completed 4 weeks post
discharge (T8).

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 T1-T8. The average of 3 scores will be used.

B. Pain on palpation: Defined as pain to pressure over top 3 areas of primary complaint.
Palpation pressure recorded as mild, moderate, heavy. If algometry is used, average number of
3 trials will be used.

A. 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 on
clinic visit T1, T3, T5, T7, and T8.

B. 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 T1, T3,
and T7, and T8.

C. Global Rating of Change scale (GRC): 7-point self-assessed clinical progress scale of
participant's perception of their change in status. Measured at T3, T7, and T8.

D. Digital thermography photo: Using a digi-therm camera, a thermogram image of the spine and
upper or lower extremity will be taken for comparison of areas of circulation and
inflammation. Measured at T1, T3, T5, T7, and T8.

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.

Inclusion Criteria:

1. 18-80 years old

2. Primary referral and acceptance to the UTSW McDermott Multidisciplinary Pain
Management Program. All diagnoses will be included.

3. Physical therapy specific inclusion for acceptance to the pain program (and this
study) include:

1. Musculoskeletal pain greater than 3 months

2. Pain upon palpation or with movement of the extremities

3. Medically cleared for physical therapy (exercise) in terms of cardiac,
orthopedic, neurological impairments.

4. Cognitive, verbal, and physical abilities to self-detect and report pain and changes
in exercise effort.

5. Ability to speak English and follow exercise based instructions.

6. Able to give informed consent.

Exclusion Criteria:

1. Inability to meet inclusion criteria for pain program

2. Current use of photosensitive medication (has been instructed to minimize sun
exposure)

3. Active metastasis

4. Active infection

5. Diagnoses that exclude PT including cauda equine syndrome, myopathy, acute fracture
(8-weeks).

6. Impaired sensation