Temporomandibular Joint Pain Clinical Trial
Official title:
Pulsed Radiofrequency As A Treatment For Mastecatory Muscle Pain In Temporomandibular Disorder Patients
Verified date | February 2019 |
Source | McGill University Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
PRF of the masticatory muscles (masseter, temporalis, medial and lateral pterygoid muscle) can improve pain intensity and functional recovery of the jaw in patients with extra-articular TMD.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Thirty consecutive patients, male and female, between 18 and 80 years old, with extra-articular TMD as diagnosed by a specialist of the Maxillofacial team based on Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) for Clinical and Research Applications, with chronic pain related to TMD (for more than three months according to IASP definition), and who have plateaued with conventional treatment in the past three months, will be prospectively recruited at the Maxillofacial Surgery Clinic Exclusion Criteria: - • Patients younger than 18 years old. - ASA physical status >3, - Contraindication for local anesthetics or RF. - Immunosuppression or high risk of infection. - Coagulation impairment. - Patients with psychiatric illness. - Patients with cognitive impairment. - Patients currently taking opioids. - Patients that had botulinum toxin or steroid injections in the head or neck area in the past three months. - Patient with pacemaker. - Patient with prosthetic joint replacement, or placement of any metallic surgical device in or around the area of treatment. - Infection of the TMJ. - Muscular dystrophy. - Pathology or impaired masticatory muscles. - Pregnancy. - Autoimmune diseases. - Arthralgia or intra-articular joint dysfunction. - Patients with allergy to Cefazolin. |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Center |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in static and dynamic TMD pain | using Numerical Rating Scale (NRS) at the end of the procedure (NRS post-procedure), and in the follow-up at 4 weeks and 12 weeks post-procedure. | 30 minutes, 4 and 12 weeks post procedure | |
Secondary | change in maximal mouth opening | by measurement of maximum mouth opening (MMO) in centimetres | 30 minutes, 4 and 12 weeks post procedure | |
Secondary | Pain medications use | In oral morphine equivalence | 30 minutes, 4 and 12 weeks post procedure | |
Secondary | Change in lateral jaw excursion | By measurement of lateral jaw excursion in centimetres | 30 minutes, 4 and 12 weeks post procedure | |
Secondary | Change in jaw protrusion | By measurement of jaw protrusion in centimetres | 30 minutes, 4 and 12 weeks post procedure |
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