Low-level Laser Therapy in Patients With Chronic 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.

Inclusion Criteria:

1. 18-80 years old

2. Pre-existing medical conditions are under stable control

3. Diagnosis of fibromyalgia by Widespread Pain Index and Symptom Severity Score

4. Able to wear laser protective eyewear during the treatment session

5. Ability to speak English and complete testing

Exclusion Criteria:

1. Presence of another pain syndrome that has anatomical overlapping with fibromyalgia
pain

2. Unstable psychiatric disorders or cognitive dysfunction or serious memory impairment

3. Previous treatment with low level laser therapy

4. Contraindication to receiving laser treatments

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

6. Active metastasis

7. Active infection

8. Impaired sensation