Recruiting

PRF

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT03848169

Conditions

Temporomandibular Joint Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Radiofrequency

Study Details

Brief summary:

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.

Conditions

Temporomandibular Joint Pain

Study ID

NCT03848169

Start date

Mar 1, 2018

Status verified date

Feb, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental group

Ultrasound guidance will be used with a high- frequency linear transducer.After the joint has been identified, the researcher will ask the patient to hold mouth in a neutral position. Masseter, temporalis, medial and lateral pterygoid muscles will be then identified, and with a sterile marker the operator will determine the best point of entry for each muscle injection. Lidocaine 1% will be injected for the skin, always under ultrasound vision. RF needle (18 G, 50 mm of length and active tip of 3 mm) will be inserted into each one of the muscles mentioned previously. Then, through the RF needle, 0.5 ml of normal saline will be injected (to decrease the impedance of the tissues), the electrode will be inserted, and extra-articular PRF will be performed during 4 minutes at 42 degrees Celsius for each muscle. At the end of each muscle treatment, 1 ml of local anesthetic (lidocaine 1%) will be injected through the RF needle, and the needle will be removed.

sham comparator: Control Group

Ultrasound guidance will be used with a high- frequency linear transducer. After the joint has been identified, the researcher will ask the patient to hold his or her mouth in a neutral position. Masseter, temporalis and lateral pterigoid muscles will be then identified, and with a sterile marker the operator will determine the best point of entry for each muscle injection (mainly over the most common sites of trigger points for the masticatory muscles). Lidocaine 1% will be injected for the skin, always under ultrasound vision. RF needle (18 G, 50 mm of length and active tip of 3 mm) will be inserted into each one of the muscles mentioned previously. Then, through the RF needle, an electrode will not be inserted, but a simulation for PRF will be done during 4 minutes for each muscle (sham). At the end of each muscle puncture, 1 ml of local anesthetic (lidocaine 1%) will be injected through the needle, and the needle will be removed.

Interventions

Radiofrequency

See previous page

Primary outcome measure

  • Change in static and dynamic TMD pain [ Time Frame: 30 minutes, 4 and 12 weeks post procedure ]

Central Contacts and Locations

Locations

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3A 1A1

Contacts

JF Asenjo, MD

514) 934-1934jfasenjog@yahoo.com

Principal Investigator:

JF Asenjo, MD

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Feb 20, 2019

Last verified

Feb, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2019-02-20.