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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Pain
Interventions Device: Sham Phoenix Laser Treatment
Device: Active Phoenix Laser Treatment
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sham Phoenix Laser Treatment Active Phoenix Laser Treatment
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
Started 17 11
Completed 7 9
Not Completed 10 2
Reason Not Completed
Lack of efficacy and study suspended             10             2
Arm/Group Title Sham Phoenix Laser Treatment Active Phoenix Laser Treatment Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 17 11 28
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 11 participants 28 participants
53.0  (10.3) 53.0  (10.2) 53.0  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 11 participants 28 participants
Female
17
 100.0%
11
 100.0%
28
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Percent
Number Analyzed 17 participants 11 participants 28 participants
% white 75 75 75
% black 25 25 25
Revised Symptom Impact Questionnaire  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 17 participants 11 participants 28 participants
62.0  (7.6) 68.3  (14.8) 65.7  (12.5)
1.Primary Outcome
Title The Revised Symptom Impact Questionnaire
Hide Description Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0.
Time Frame baseline, 1 week, and 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Phoenix Laser Treatment Active Phoenix Laser Treatment
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 62.0  (7.6) 68.3  (14.8)
1 week 47.1  (21.8) 50.5  (22.5)
1 month 45.8  (22.5) 50.2  (25.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Phoenix Laser Treatment, Active Phoenix Laser Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Secondary Outcome
Title RAND 36-Item Health Survey
Hide Description Pain Domain: 2 Questions, 0 minimum/worse score, 100 maximum/best score
Time Frame baseline, 1 week, and 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Phoenix Laser Treatment Active Phoenix Laser Treatment
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline 27.2  (13.0) 27.2  (15.2)
1 week 33.6  (2.7) 37.8  (20.6)
1 month 41.8  (5.5) 36.4  (22.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Phoenix Laser Treatment, Active Phoenix Laser Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title Global Rating of Change Scale
Hide Description Self report tool describing the degree of change since baseline. Minimum/worse value is -7. Maximum/best value is +7.
Time Frame 1 week and 1 month after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sham Phoenix Laser Treatment Active Phoenix Laser Treatment
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 7 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
1 week 0.4  (3.3) 2.8  (2.0)
1 month 0  (3.1) 1.3  (3.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sham Phoenix Laser Treatment, Active Phoenix Laser Treatment
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sham Phoenix Laser Treatment Active Phoenix Laser Treatment
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Sham Phoenix Laser Treatment Active Phoenix Laser Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/11 (0.00%) 
Hide Serious Adverse Events
Sham Phoenix Laser Treatment Active Phoenix Laser Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sham Phoenix Laser Treatment Active Phoenix Laser Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jason Zafereo
Organization: UT Southwestern
Phone: 14-648-1002 ext 2146481002
EMail: jason.zafereo@utsouthwestern.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02948634    
Other Study ID Numbers: STU 072016-079
First Submitted: October 19, 2016
First Posted: October 28, 2016
Results First Submitted: July 1, 2019
Results First Posted: March 3, 2020
Last Update Posted: March 3, 2020