The purpose of this study is to examine the use of low level therapeutic laser (LLLT) for its effects on pain, fatigue, and physical function in individuals with fibromyalgia.
Fifty consenting participants with long-standing fibromyalgia (\> 3 mo duration) will be randomized to one of two treatment groups (n=25 per group) according to a computer generated randomization table. Group 1 will be the 'sham' control group and Group 2 will be the 'active' laser treatment group. The study will be conducted in a double-blind fashion using a standard 42 watt Class IV laser which has a switch at the back of the device which allows the laser to operate in the 'inactive' mode despite giving the operator and patients the appearance of being active (e.g., generates skin warmth and a red beam of light). Treatment will be administered three times/week for three weeks. Data will be collected across the 3-week intervention and one week after completion of the intervention. Data will be analyzed with appropriate statistical methods. The following outcome measures will be collected at baseline: (1)Standardized SF-36 questionnaire; (2) Symptom Impact Questionnaire; (3) current analgesic medication usage; (4) pressure-pain threshold testing over tender points; and (5) spinal range of motion with an inclinometer and accelerometer. Outcome measures (2) and (3) will be re-assessed during the treatment phase at the end of weeks 1, 2 and 3. At 1 week and 1 month after the last laser/sham treatment session, all baseline assessments will be repeated, in addition to a global rating of change scale. Any patient who reports any harm from the laser/sham treatments on the helpfulness scale will be queried for specific harm details.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy. Intervention will take place in the therapy room at the McDermott Center for Pain Management, which is appropriately equipped for laser administration. Application of therapeutic laser will be completed by licensed physical therapists who have completed safety training for therapeutic laser application including appropriate use of safety eyewear, room access, laser signage for laser use, and patient monitoring.
The 30 min treatments will include multiple 60 sec applications to all tender points on the spine or extremities and a 10 minute application along the bilateral sympathetic ganglion in the paraspinous region. The treatment will be applied via a non-contact method, with the laser applicator held 12-18 inches above the participant's skin.
McDermott Pain Management Clinic
Dallas, Texas, United States
The Revised Symptom Impact Questionnaire
Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0.
Time frame: baseline, 1 week, and 1 month after treatment
RAND 36-Item Health Survey
Pain Domain: 2 Questions, 0 minimum/worse score, 100 maximum/best score
Time frame: baseline, 1 week, and 1 month after treatment
Global Rating of Change Scale
Self report tool describing the degree of change since baseline. Minimum/worse value is -7. Maximum/best value is +7.
Time frame: 1 week and 1 month after treatment
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