Chronic PainNCT02948634
Low-level Laser Therapy in Patients With Chronic Fibromyalgia
A study testing Active Phoenix Laser Treatment in people with Chronic Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Active Phoenix Laser Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- Pre-existing medical conditions are under stable control
- Diagnosis of fibromyalgia by Widespread Pain Index and Symptom Severity Score
- Able to wear laser protective eyewear during the treatment session
- Ability to speak English and complete testing
Who cannot join
- Presence of another pain syndrome that has anatomical overlapping with fibromyalgia pain
- Unstable psychiatric disorders or cognitive dysfunction or serious memory impairment
- Previous treatment with low level laser therapy
- Contraindication to receiving laser treatments
- Current use of photosensitive medication (has been instructed to minimize sun exposure)
- Active metastasis
- Active infection
- Impaired sensation
Trial locations and contacts
1 site in 1 country.
United States1 site
McDermott Pain Management Clinic
Dallas, Texas, 75390
About this study
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
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Sham Phoenix Laser Treatment, Active Phoenix Laser Treatment
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham Phoenix Laser TreatmentDevice
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 Phoenix Laser TreatmentDevice
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 group | Role | What they receive |
|---|---|---|
| Sham Phoenix Laser Treatment | Sham comparator | 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. Receives: Device: Sham Phoenix Laser Treatment |
| Active Phoenix Laser Treatment | Active comparator | 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. Receives: Device: Active Phoenix Laser Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Revised Symptom Impact Questionnaire
Self-Report Questionnaire containing 21 questions, maximum/worse score=100; minimum/best score=0.
Measured: baseline, 1 week, and 1 month after treatment
Secondary outcomes (2)
RAND 36-Item Health Survey
Pain Domain: 2 Questions, 0 minimum/worse score, 100 maximum/best score
Measured: baseline, 1 week, and 1 month after treatment
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.
Measured: 1 week and 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2019
- Study completionJun 2019
Why it stopped: Lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Zafereo, PT, PhD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948634
- Sponsor's protocol ID
- STU 072016-079
- Status last verified
- Feb 2020
- First submitted
- 19 Oct 2016
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02948634
- Acronym / sponsor ID
- STU 072016-079
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of financial support
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Posted 3 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Phoenix Laser Treatment | Sham comparator | Device: Sham Phoenix Laser TreatmentEach 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. |
| Active Phoenix Laser Treatment | Active comparator | Device: Active Phoenix Laser TreatmentEach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years old
- Pre-existing medical conditions are under stable control
- Diagnosis of fibromyalgia by Widespread Pain Index and Symptom Severity Score
- Able to wear laser protective eyewear during the treatment session
- Ability to speak English and complete testing
Key exclusion criteria (8 listed)
- Presence of another pain syndrome that has anatomical overlapping with fibromyalgia pain
- Unstable psychiatric disorders or cognitive dysfunction or serious memory impairment
- Previous treatment with low level laser therapy
- Contraindication to receiving laser treatments
- Current use of photosensitive medication (has been instructed to minimize sun exposure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sham Phoenix Laser TreatmentSham 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 | Sham Phoenix Laser Treatment |
| Active Phoenix Laser TreatmentThe 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. | Device | Active Phoenix Laser Treatment |
Primary outcome
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.
2 secondary outcomes
RAND 36-Item Health Survey
Time frame: baseline, 1 week, and 1 month after treatment
Global Rating of Change Scale
Time frame: 1 week and 1 month after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Zafereo, PT, PhD principal investigator
UT Southwestern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Phoenix Laser Treatment in people with Chronic Pain, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Revised Symptom Impact Questionnaire (time frame: baseline, 1 week, and 1 month after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.