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TMD Pulsed Radiofrequency

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ClinicalTrials.gov Identifier: NCT03848169
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
JF Asenjo, McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Joint Pain Other: Radiofrequency Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulsed Radiofrequency As A Treatment For Mastecatory Muscle Pain In Temporomandibular Disorder Patients
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
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.
Other: Radiofrequency
See previous page

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.
Other: Radiofrequency
See previous page




Primary Outcome Measures :
  1. Change in static and dynamic TMD pain [ Time Frame: 30 minutes, 4 and 12 weeks post procedure ]
    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.


Secondary Outcome Measures :
  1. change in maximal mouth opening [ Time Frame: 30 minutes, 4 and 12 weeks post procedure ]
    by measurement of maximum mouth opening (MMO) in centimetres

  2. Pain medications use [ Time Frame: 30 minutes, 4 and 12 weeks post procedure ]
    In oral morphine equivalence

  3. Change in lateral jaw excursion [ Time Frame: 30 minutes, 4 and 12 weeks post procedure ]
    By measurement of lateral jaw excursion in centimetres

  4. Change in jaw protrusion [ Time Frame: 30 minutes, 4 and 12 weeks post procedure ]
    By measurement of jaw protrusion in centimetres



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03848169


Locations
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Canada, Quebec
Montreal General Hospital Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: JF Asenjo, MD    514) 934-1934 ext 43261    jfasenjog@yahoo.com   
Principal Investigator: JF Asenjo, MD         
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre

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Responsible Party: JF Asenjo, Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03848169     History of Changes
Other Study ID Numbers: 2018-3716
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms