Clinical trial NCT02948634: Low-level Laser Therapy in Patients With Chronic Fibromyalgia
Official title: A Prospective, Randomized, Double-blind, Sham-controlled Study of the Low-level Phoenix Thera-lase 42 Watt Laser in Patients With Chronic Fibromyalgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Revised Symptom Impact Questionnaire
timeFrame: baseline, 1 week, and 1 month after treatment
Secondary outcomes:
measure: RAND 36-Item Health Survey
timeFrame: baseline, 1 week, and 1 month after treatment
measure: Global Rating of Change Scale
timeFrame: 1 week and 1 month after treatment
Other outcomes:
Locations:
city: Dallas
country: United States
facility: McDermott Pain Management Clinic
state: Texas
Study officials:
affiliation: UT Southwestern
name: Jason Zafereo, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: