Low-level Laser Therapy in Patients With Chronic Fibromyalgia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02948634|
Recruitment Status : Recruiting
First Posted : October 28, 2016
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment|
|Chronic Pain||Device: Sham Phoenix Laser Treatment Device: Active Phoenix Laser Treatment|
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|
|Estimated Enrollment :||60 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|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||October 2018|
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.
- Symptom Impact Questionnaire [ Time Frame: 8 weeks ]
- 36-item Short Form Survey (SF-36) for Quality of Life [ Time Frame: 8 weeks ]
- Global Rating of Change Scale [ Time Frame: 8 weeks ]
- Medication Usage Scale [ Time Frame: 8 weeks ]
- Algometry to assess pain pressure threshold [ Time Frame: 8 weeks ]
- Accelerometry to assess spinal range of motion [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948634
|Contact: Jason Zafereo, PT, PhDemail@example.com|
|United States, Texas|
|McDermott Pain Management Clinic||Recruiting|
|Dallas, Texas, United States, 75390|
|Contact: Jason Zafereo, PT, PhD 214-648-1002 firstname.lastname@example.org|
|Principal Investigator: Ross Querry, PT, PhD|
|Principal Investigator:||Jason Zafereo, PT, PhD||UT Southwestern|