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Trial record 51 of 103 for:    fibromyalgia | Open Studies | Interventional Studies

Low-level Laser Therapy in Patients With Chronic Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT02948634
First received: October 19, 2016
Last updated: March 8, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention
Chronic Pain
Device: Sham Phoenix Laser Treatment
Device: Active Phoenix Laser Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Symptom Impact Questionnaire [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: October 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02948634

Contacts
Contact: Jason Zafereo, PT, PhD 214-648-1002 jason.zafereo@utsouthwestern.edu

Locations
United States, Texas
McDermott Pain Management Clinic Recruiting
Dallas, Texas, United States, 75390
Contact: Jason Zafereo, PT, PhD    214-648-1002    jason.zafereo@utsouthwestern.edu   
Principal Investigator: Ross Querry, PT, PhD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Jason Zafereo, PT, PhD UT Southwestern
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02948634     History of Changes
Other Study ID Numbers: STU 072016-079
Study First Received: October 19, 2016
Last Updated: March 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Chronic Pain
Fibromyalgia
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on April 24, 2017