Photobiomodulation for the Management of Temporomandibular Disorder Pain (PBM)

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University of Florida

Status

Terminated

Conditions

Pain Related to TMD

Treatments

Device: THOR® laser system
Device: sham THOR® laser system

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04415281
IRB202000766

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

14 participants in 2 patient groups

Active PBM
Experimental group
Description:
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.
Treatment:
Device: THOR® laser system
Sham PBM
Sham Comparator group
Description:
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.
Treatment:
Device: sham THOR® laser system

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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