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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
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE October 19, 2016
First Posted Date  ICMJE October 28, 2016
Results First Submitted Date  ICMJE July 1, 2019
Results First Posted Date  ICMJE March 3, 2020
Last Update Posted Date March 3, 2020
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
Symptom Impact Questionnaire [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2020)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2016)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low-level Laser Therapy in Patients With Chronic Fibromyalgia
Official Title  ICMJE A Prospective, Randomized, Double-blind, Sham-controlled Study of the Low-level Phoenix Thera-lase 42 Watt Laser in Patients With Chronic Fibromyalgia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Sham Phoenix Laser Treatment
  • 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.
    Intervention: Device: Active Phoenix Laser Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 19, 2020)
28
Original Estimated Enrollment  ICMJE
 (submitted: October 26, 2016)
60
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02948634
Other Study ID Numbers  ICMJE STU 072016-079
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason Zafereo, PT, PhD UT Southwestern
PRS Account University of Texas Southwestern Medical Center
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP