TMD Pulsed Radiofrequency

NCT03848169 | Unknown

• 1 other identifier: 2018-3716
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• change in maximal mouth opening

  30 minutes, 4 and 12 weeks post procedure

• Pain medications use

  30 minutes, 4 and 12 weeks post procedure

• Change in lateral jaw excursion

  30 minutes, 4 and 12 weeks post procedure

• Change in jaw protrusion

  30 minutes, 4 and 12 weeks post procedure

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Radiofrequency

Control Group

SHAM COMPARATOR

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.

Other: Radiofrequency

Interventions

Radiofrequency OTHER

See previous page

Control Group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: February 20, 2019
• Study Start: March 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

CA (1)