Low-level Laser Therapy in Patients With Chronic Fibromyalgia

Not Applicable

Terminated

• Conditions: Chronic Pain
• Interventions: Device: Active Phoenix Laser Treatment; Device: Sham Phoenix Laser Treatment

• Registration Number: NCT02948634
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Primary Completion: 2019-06
• Study Completion: 2019-06
• Results First Submitted: 2019-07-01
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-19
• Last Update Submitted: 2020-02-19
• Results First Posted: 2020-03-03
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Phoenix Laser Treatment	Active Phoenix Laser Treatment	Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. Participants in the laser treatment group will be treated at 42 watts for up to 60 seconds at tender spots in the spine or extremities. Total treatment time is not to exceed 30 minutes.
Sham Phoenix Laser Treatment	Sham Phoenix Laser Treatment	Each participant will receive a series of nine active laser or sham treatments on a M-W-F schedule over the three week treatment period. 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.

Primary Outcome Measures

Name	Time	Method
The Revised Symptom Impact Questionnaire	baseline, 1 week, and 1 month after treatment	Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0.

Secondary Outcome Measures

Name	Time	Method
Global Rating of Change Scale	1 week and 1 month after treatment	Self report tool describing the degree of change since baseline. Minimum/worse value is -7. Maximum/best value is +7.
RAND 36-Item Health Survey	baseline, 1 week, and 1 month after treatment	Pain Domain: 2 Questions, 0 minimum/worse score, 100 maximum/best score

Trial Locations

Locations (1)

McDermott Pain Management Clinic; 🇺🇸 Dallas, Texas, United States