Chronic Pain
Conditions
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.
Interventions
DEVICESham 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.
DEVICEActive 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.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Revised Symptom Impact Questionnaire | baseline, 1 week, and 1 month after treatment | Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RAND 36-Item Health Survey | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 17 |
| 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.
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. | 11 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of efficacy and study suspended | 10 | 2 |
Baseline characteristics
| Characteristic | Sham Phoenix Laser Treatment | Active Phoenix Laser Treatment | Total |
|---|---|---|---|
| Age, Continuous | 53.0 years STANDARD_DEVIATION 10.3 | 53.0 years STANDARD_DEVIATION 10.2 | 53.0 years STANDARD_DEVIATION 10.2 |
| Race/Ethnicity, Customized % black | 25 percent | 25 percent | 25 percent |
| Race/Ethnicity, Customized % white | 75 percent | 75 percent | 75 percent |
| Revised Symptom Impact Questionnaire | 62.0 units on a scale STANDARD_DEVIATION 7.6 | 68.3 units on a scale STANDARD_DEVIATION 14.8 | 65.7 units on a scale STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 17 Participants | 11 Participants | 28 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 11 |
| other Total, other adverse events | 0 / 17 | 0 / 11 |
| serious Total, serious adverse events | 0 / 17 | 0 / 11 |
Outcome results
Primary
The Revised Symptom Impact Questionnaire
Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0.
Time frame: baseline, 1 week, and 1 month after treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Phoenix Laser Treatment | The Revised Symptom Impact Questionnaire | Baseline | 62.0 score on a scale | Standard Deviation 7.6 |
| Sham Phoenix Laser Treatment | The Revised Symptom Impact Questionnaire | 1 week | 47.1 score on a scale | Standard Deviation 21.8 |
| Sham Phoenix Laser Treatment | The Revised Symptom Impact Questionnaire | 1 month | 45.8 score on a scale | Standard Deviation 22.5 |
| Active Phoenix Laser Treatment | The Revised Symptom Impact Questionnaire | Baseline | 68.3 score on a scale | Standard Deviation 14.8 |
| Active Phoenix Laser Treatment | The Revised Symptom Impact Questionnaire | 1 week | 50.5 score on a scale | Standard Deviation 22.5 |
| Active Phoenix Laser Treatment | The Revised Symptom Impact Questionnaire | 1 month | 50.2 score on a scale | Standard Deviation 25.3 |
p-value: 0.43ANOVA
Secondary
Global Rating of Change Scale
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Phoenix Laser Treatment | Global Rating of Change Scale | 1 week | 0.4 score on a scale | Standard Deviation 3.3 |
| Sham Phoenix Laser Treatment | Global Rating of Change Scale | 1 month | 0 score on a scale | Standard Deviation 3.1 |
| Active Phoenix Laser Treatment | Global Rating of Change Scale | 1 week | 2.8 score on a scale | Standard Deviation 2 |
| Active Phoenix Laser Treatment | Global Rating of Change Scale | 1 month | 1.3 score on a scale | Standard Deviation 3.9 |
p-value: <0.05Wilcoxon (Mann-Whitney)
Secondary
RAND 36-Item Health Survey
Pain Domain: 2 Questions, 0 minimum/worse score, 100 maximum/best score
Time frame: baseline, 1 week, and 1 month after treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sham Phoenix Laser Treatment | RAND 36-Item Health Survey | Baseline | 27.2 score on a scale | Standard Deviation 13 |
| Sham Phoenix Laser Treatment | RAND 36-Item Health Survey | 1 week | 33.6 score on a scale | Standard Deviation 2.7 |
| Sham Phoenix Laser Treatment | RAND 36-Item Health Survey | 1 month | 41.8 score on a scale | Standard Deviation 5.5 |
| Active Phoenix Laser Treatment | RAND 36-Item Health Survey | Baseline | 27.2 score on a scale | Standard Deviation 15.2 |
| Active Phoenix Laser Treatment | RAND 36-Item Health Survey | 1 week | 37.8 score on a scale | Standard Deviation 20.6 |
| Active Phoenix Laser Treatment | RAND 36-Item Health Survey | 1 month | 36.4 score on a scale | Standard Deviation 22.6 |
p-value: 0.32ANOVA