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Temporomandibular Joint PainNCT03848169

TMD Pulsed Radiofrequency

A study testing Radiofrequency in people with Temporomandibular Joint Pain, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Temporomandibular Joint Pain
What is being tested?
Radiofrequency
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteCanada
Study dates
1 Mar 2018to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site, 1 recruiting
  • Montreal General Hospital

    Montreal, Quebec, H3A 1A1

    JF Asenjo, MD, 514) 934-1934 ext. 43261, jfasenjog@yahoo.com

    JF Asenjo, MD

    Recruiting

Other trials in Canada

About this study

Official title: Pulsed Radiofrequency As A Treatment For Mastecatory Muscle Pain In Temporomandibular Disorder Patients

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.

Read the detailed description

The temporomandibular joint is formed by the mandibular condyle inserting into the mandibular fossa of the temporal bone. Muscles of mastication are primarily responsible for the movement of this joint. Its functionality may be affected by different disorders that are characterized by craniofacial pain involving the joint, masticatory muscles, or muscle innervations of the head and neck. These are known as temporomandibular disorders (TMD). It affects 10% to 15% of adults, but only 5% seek treatment. The incidence of TMD peaks from 20 to 50 years of age and are more common in female population.

TMD is categorized as intra-articular (within the joint) or extra-articular (involving the surrounding musculature). Musculoskeletal conditions (myofascial pain disorder) are the most frequent cause of TMD, accounting for at least 50% of cases. Thus, musculoskeletal conditions associated with TMD include spasm and/or tenderness to palpation of the masseter, temporalis, and/or pterygoid muscles.

Etiology of TMD is multifactorial. Factors consistently associated with TMD include other pain conditions, fibromyalgia, autoimmune disorders, sleep apnea and psychiatric illness. According to the literature, there is 1.8-fold increase in myofascial pain in people with anxiety.

It is important to mention that patients with TMD present with an increase risk to develop chronic and intense headaches. The relationship between chronic TMD and various headaches could be due to similarity in the pathophysiology of both diseases.4-6 Studies suggest, that the trigeminal nucleus contribute to central sensitization associated to interference in descending modulation, and could produce the amplification of pain in this region.

Treatment for TMD is complicated and requires specific knowledge and exercises to strengthen some groups of muscles and stretch others, occlusal splint therapy, massage, trigger point injections, and pharmacotherapy. Although the management seems difficult, most of the patients experience successful improvement once a proper protocol has been established. Muscle relaxants (baclofen, tizanidin, cyclobenzaprine), nonsteroidal anti-inflammatory drugs (NSAIDS), opioids, anticonvulsants (e.g., gabapentin), ketamine, tricyclic antidepressants (e.g., amitriptyline) and benzodiazepines, have also been used clinically for TMD management, but there is no evidence that supports or refutes the effectiveness of these medications. In some cases where patients present with severe acute pain, or chronic pain secondary to serious TMD, inflammation, or degeneration, minimally invasive and invasive procedures should be considered.

As a general concept, pain treatment by radiofrequency (RF) energy is a technique widely used in the pain practice. RF denervation is a percutaneous procedure involving the destruction of nerves using heat generated by a RF current. The basic principles of RF, involve transferring an alternating electrical current by a generator to a nerve via an active electrode. The electrode is introduced through an insulated needle, with the exposed active tip transferring the current to the surrounding tissues.

It is worth mentioning that for interventional pain management purposes there are different modes of RF that could be used: the continuous RF (CRF) lesion where the heat generated causes tissue coagulation over 65 degrees Celsius, and the pulsed RF (PRF), which is a non-destructive procedure where electrical bursts of 20 milliseconds of electricity are applied followed by 480 milliseconds of no current to allow heat to dissipate, keeping the tissue temperature below 42 degrees Celsius. Even though different theories have been suggested for PRF mechanism of action, Vallejo et al. propose that PRF is able to modulate nerve electrical conduction, and the therapeutic effect is the result of the electrical field, where c-fos activation and potential effect over the norepinephrine and serotonin systems have been involved.

Several studies point to a thermal physical effect of PRF for myofascial pain syndrome. It is proposed, that PRF acts delivering the electric field and heat bursts to the targeted tissues, without damaging these structures, and blocking the central sensitization and producing a better response of the downward pathways of pain. So far, several studies have reported the positive effect of PRF on managing pain syndrome mainly for trapezius muscle and gastrocnemius.

Tamimi et al, published a case series of PRF treatment for myofascial trigger points and scar neuromas. They found that 89% of the patients with longstanding myofascial or neuromatous pain that was refractory to previous treatments, experienced 75-100% reduction in their pain following PRF management. The researchers also found that 67% of the patients experienced 6 months to greater than one year of pain relief. Despite the small size of the sample, the authors conclude that PRF could be a minimally invasive, less neurodestructive treatment modality for these painful conditions.

Taking in consideration previous facts mentioned above and the lack of strong and high-quality evidence for the use of PRF for extra-articular TMD, there is a specific interest to develop a prospective pilot study to test the application of this technique into the main affected muscles that contribute for development of temporomandibular pain. PRF could be an alternative that might offer an effective way to treat pain in this population with myofascial origin of pain. Hence, the purpose of this research is to evaluate the improvement of temporomandibular pain intensity and functionality of the jaw, after extra-articular PRF in patients with TMD.

Being tested
Radiofrequency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiofrequencyOther

    See previous page

Study groups in NCT03848169
Study groupRoleWhat they receive
Experimental groupExperimentalUltrasound 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.
Receives: Other: Radiofrequency
Control GroupSham comparatorUltrasound 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.
Receives: Other: Radiofrequency

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 minutes, 4 and 12 weeks post procedure

Secondary outcomes (4)
  1. change in maximal mouth opening

    by measurement of maximum mouth opening (MMO) in centimetres

    Measured: 30 minutes, 4 and 12 weeks post procedure

  2. Pain medications use

    In oral morphine equivalence

    Measured: 30 minutes, 4 and 12 weeks post procedure

  3. Change in lateral jaw excursion

    By measurement of lateral jaw excursion in centimetres

    Measured: 30 minutes, 4 and 12 weeks post procedure

  4. Change in jaw protrusion

    By measurement of jaw protrusion in centimetres

    Measured: 30 minutes, 4 and 12 weeks post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2019
  2. Study start1 Mar 2018
  3. Primary completion1 Dec 2019 (estimated)
  4. Study completion31 Dec 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03848169
Sponsor's protocol ID
2018-3716
Status last verified
Feb 2019
First submitted
20 Aug 2018
Last updated
20 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Radiofrequency in people with Temporomandibular Joint Pain, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in static and dynamic TMD pain (time frame: 30 minutes, 4 and 12 weeks post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.

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