Low-level Laser Therapy in Patients With Chronic Fibromyalgia

A Prospective, Randomized, Double-blind, Sham-controlled Study of the Low-level Phoenix Thera-lase 42 Watt Laser in Patients With Chronic Fibromyalgia

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Sham Phoenix Laser Treatment; Device: Active Phoenix Laser Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • McDermott Pain Management Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: 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.	Device: Sham Phoenix Laser Treatment; 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.
ACTIVE_COMPARATOR: 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.	Device: Active Phoenix Laser Treatment; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RAND 36-Item Health Survey	Pain Domain: 2 Questions, 0 minimum/worse score, 100 maximum/best score	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.	1 week and 1 month after treatment

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Jason Zafereo, PT, PhD, UT Southwestern

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): June 1, 2019
• Study Completion (ACTUAL): June 1, 2019

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 26, 2016
• First Posted (ESTIMATE): October 28, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Chronic Pain; Fibromyalgia
• Other Study ID Numbers: STU 072016-079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO