Pain Related to TMD
Conditions
Brief summary
Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for TMD pain. Also, we propose to determine if PBM-induced changes in inflammation contribute to PBM's analgesic effects. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.
Interventions
DEVICETHOR® laser system
We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.
DEVICEsham THOR® laser system
sham THOR® laser system
Sponsors
National Institute of Dental and Craniofacial Research (NIDCR)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provides a signed and dated informed consent form * Is at least 18 years of age (male or female and any race or ethnicity) * Meets diagnostic criteria for TMD, ( Masticatory Muscle Disorders, 1A: Myalgia) * Has experienced facial pain for at least 3 months * At Screening and Baseline Visit (Visit 0), reports an average pain intensity rating over the past week of ≥ 30 on a numerical rating scale (0-100)
Exclusion criteria
* Starting a new daily prescription medication for the management of pain within 30 days prior to treatment session; * Use of any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks prior to the CATI; * Starting occlusal appliance therapy within 30 days prior to CATI; d) history of facial trauma or orofacial surgery within 6 weeks prior to CATI; * Active orthodontic treatment; * Psychiatric hospitalization within one year prior to screening. * Has known hypersensitivity to laser therapy. * Currently being treated with chemotherapy or radiation therapy * Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit * Is pregnant or nursing * Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable | Through study completion; an average of 10 weeks | Using a numerical rating scale (NRS) requires the patient to rate their pain on a defined scale 0=no pain and 100=the most intense pain imaginable to rate the average daily pain from Daily Pain & Symptom Dairy over one week prior to V1 will be compared to the average daily pain one week prior to V8. |
Countries
United States
Participant flow
Pre-assignment details
One person was enrolled but withdrew prior to being assigned to a group which is why 14 people were enrolled but only 13 started
Participants by arm
| Arm | Count |
|---|---|
| Active PBM PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.
THOR® laser system: We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation. | 7 |
| Sham PBM When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.
sham THOR® laser system: sham THOR® laser system | 6 |
| Total | 13 |
Baseline characteristics
| Characteristic | Active PBM | Sham PBM | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 5 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 7 participants | 6 participants | 13 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 0 / 7 | 1 / 6 |
| serious Total, serious adverse events | 0 / 7 | 0 / 6 |
Outcome results
Primary
Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable
Using a numerical rating scale (NRS) requires the patient to rate their pain on a defined scale 0=no pain and 100=the most intense pain imaginable to rate the average daily pain from Daily Pain & Symptom Dairy over one week prior to V1 will be compared to the average daily pain one week prior to V8.
Time frame: Through study completion; an average of 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active PBM | Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable | 5.8 score on a scale | Standard Deviation 10.1 |
| Sham PBM | Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable | 8.0 score on a scale | Standard Deviation 18 |