Low-level Laser Therapy in Patients With Chronic Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT02948634|
Recruitment Status : Terminated (Lack of financial support)
First Posted : October 28, 2016
Results First Posted : March 3, 2020
Last Update Posted : March 3, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Device: Sham Phoenix Laser Treatment Device: Active Phoenix Laser Treatment||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
|Actual Study Start Date :||October 2016|
|Actual Primary Completion Date :||June 2019|
|Actual Study Completion Date :||June 2019|
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.
- The Revised Symptom Impact Questionnaire [ Time Frame: baseline, 1 week, and 1 month after treatment ]Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0.
- RAND 36-Item Health Survey [ Time Frame: baseline, 1 week, and 1 month after treatment ]Pain Domain: 2 Questions, 0 minimum/worse score, 100 maximum/best score
- Global Rating of Change Scale [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948634
|United States, Texas|
|McDermott Pain Management Clinic|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Jason Zafereo, PT, PhD||UT Southwestern|