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PainNCT05619380

Effectiveness of Physiotherapy Treatments in Temporomandibular Joint Dysfunction

A study testing physiotherapy treatment in people with Pain and Temporomandibular Joint Disorders, run by Pomeranian Medical University Szczecin at 1 site in Poland.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

The study will determinate the influence of four selected physiotherapeutic procedures on the pain intensity, the bioelectrical activity of the masseter muscle, and the range of mandibular mobility in patients with TMDs (temporomandibular joint dysfunction). Read more about this study

Who is it for?
Ages 20 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
physiotherapy treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 sitePoland
Study dates
20 Nov 2022to 30 Mar 2023
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 20 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • myofacial pain
  • limited mobility of TMJ
  • increased muscle tension
  • Female sex

Who cannot join

  • earlier splint therapy
  • pharmacotherapy
  • rheumatic diseases
  • metabolic diseases
  • fibromyalgia
  • mental diseases
Show all 11Show fewer
  • pregnancy
  • orthodontic treatment
  • inflammation in the oral cavity
  • masticatory organ injury
  • lack of stability in the masticatory organ motor system

Trial locations and contacts

1 site in 1 country.

Magdalena Gębska, PhD contact

914417253

mgebska@pum.edu.pl

Poland1 site, 1 recruiting
  • Department of Musculoskeletal System Rehabilitation, Pomeranian Medical University

    Szczecin

    Recruiting

Other trials in Poland

About this study

Official title: The Effect of Manual Therapy and Therapeutic Exercises on Mandibular Analgesia, Muscles Relaxation, and Range of Motion in Patients With Masticatory Muscles Disorder

The study will determinate the influence of four selected physiotherapeutic procedures on the pain intensity, the bioelectrical activity of the masseter muscle, and the range of mandibular mobility in patients with TMDs (temporomandibular joint dysfunction).

Read the detailed description

Temporomandibular joint disorders (TMDs) are a major public health problem as they are one of the primary sources of chronic pain and impairment of chewing, swallowing, speech, and breathing function [1]. TMDs are not limited to the temporomandibular joints (TMJ) or masticatory muscles alone. Still, they are often associated with other symptoms affecting the head and neck region, such as headache, ear symptoms, and cervical spine dysfunction [1].

In recent years, there has been a significant development in the knowledge of the aetiology, diagnosis and treatment of TMDs. With the continuous search for better diagnostic and therapeutic methods, attention has begun to turn to the possibility of using non-invasive therapeutic strategies in patients with TMDs symptoms. In particular, the collaboration between dentist and physiotherapist helps in early diagnosis and improves the effectiveness of therapeutic interventions [2].

The limited number of randomised controlled trials (RCTs) comparing the efficacy of soft tissue manual therapy and self-therapy interventions prompted the researchers to focus on the analgesic and myorelaxant use of massage, post-isometric muscle relaxation (PIR) and therapeutic exercise in female patients with TMDs.

The main goals of using physiotherapy to treat TMDs are to reduce pain, reduce hypertonic muscle hyperactivity and improve tension in hypotonic muscles, restore TMJ joint mobility, and enhance mandibular proprioception and biomechanics. Physiotherapy treatment is usually reversible and non-invasive. Physiotherapy methods generally include physical techniques (laser, ultrasound, currents, heat and cold therapy), manual therapy (soft tissue therapy, joint mobilisations, massage) and therapeutic exercises. Manual therapy and therapeutic exercise in physiotherapy interventions are increasingly being used by clinicians and researched due to positive results in TMJ and some musculoskeletal problems [3].

Scientific papers show the effectiveness of masticatory muscle massage in the treatment of soft tissue disorders, achieving both muscle relaxation, improved tissue blood supply and joint range of motion and reduced pain [4]. Post-isometric relaxation (PIR) is one of the most well-known mobilisation techniques using muscle excitation and inhibition phenomena. It reduces the tension of a muscle or even an entire muscle group, as it inhibits the motoneuron field of a given muscle and thus leads to reflex relaxation. The reason for this is the activation of the Golgi tendon organs during contraction. There are 2 PIR targets - short-term and long-term. The immediate goal is primarily to combat pain and other effects of static muscle overload and to reduce muscle and connective tissue irritation. On the other hand, the long-term goal is to restore the expected length and flexibility of contracted muscles, regain normal joint range of motion and combat joint overload. As a result, post-isometric muscle relaxation is effective in, among other things, treating increased tension and reducing TrPs. It is now widely used in everyday clinical practice for both musculoskeletal therapy and TMDs.

In the daily practice of physiotherapy, it is imperative to make the patient aware of the causes and consequences of the resulting complaints and disorders. In addition to patient education, a key role is played by implementing home self-therapy into the improvement programme, mainly consisting of the systematic performance of therapeutic exercises (TE) individually selected to the patient's condition. Thanks to such management, the patient actively and consciously participates in the healing process and is taught responsibility for their own health.

Being tested
physiotherapy treatment
Keywords
manual therapy, physiotherapy, therapeutic exercises, masseter muscle, pain, electromyography, range of motion, temporomandibular joint
Medical subject headings
Pain, Temporomandibular Joint Disorders, Muscle Hypertonia, Facial Pain, Agnosia, Musculoskeletal Pain

What participants receive

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

  • physiotherapy treatmentProcedure or surgery

    Also called therapeutic exercises

    Three different physiotherapy treatments will be used for, to reduce pain and tension in the masseter muscles. The assessment of pain intensity on the VAS scale will be assessed each time after the therapy. After the 5th and 10th day of therapy, it will be measured ROM and sEMG.

Study groups in NCT05619380
Study groupRoleWhat they receive
Physiotherapeutic procedures: auto-therapy (therapeutic exercises)Active comparatorSpecialized therapeutic exercises: 1. Gerry's exercise - Starting position: tongue placed on the palate. Movement: slowly opening and closing the mouth. The number of repetitions: 6 times a day for 10 movements. 2. Active lateral movements of the mandible: Starting position: separable teeth. Movement: slow movements of the lower jaw to the right and left. The number of repetitions: 6 times a day for 10 movements. 3. Protrusion and mouth opening: Starting position: teeth separated. Movement: a) lowering the jaw forward, b) opening the mouth c) closing the mouth d) retracting the lower jaw. Number of repetitions: 6 times a day for 10 movements.
Receives: Procedure: physiotherapy treatment
Physiotherapeutic procedures: manual therapy (massage) and auto-therapy (therapeutic exercises)Active comparatorManual therapy of soft tissues in the masseter muscle: 1. Extraoral massage of the masseter muscle (duration 5 minutes) 2. Intraoral massage of the masseter muscle (duration 5 minutes) 3. Functional massage of the masseter muscle (duration 5 minutes) Auto-therapy: The patient will receive instructions on how to perform therapeutic exercises at home.
Receives: Procedure: physiotherapy treatment
Physiotherapeutic procedures: manual therapy (PIR) and auto-therapy (therapeutic exercises)Active comparatorManual therapy of soft tissues in the masseter muscle: 1. Post-isometric relaxation of the masseter muscle (duration 15 minutes). Auto-therapy: The patient will receive instructions on how to perform therapeutic exercises at home.
Receives: Procedure: physiotherapy treatment

What is being measured

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

  1. Pain relief

    Measurement on Visual Analogue Scale (VAS). It consists of a line, approximately 100 mm in length, at the left end of the scale "Score 0" witch means "no pain", at the right end of scale "Score 100mm" witch means "worst imaginable pain". The average value of all measurements will be analyzed.

    Measured: 10 days

Secondary outcomes (2)
  1. Electromyography surface of masseter muscle [uV- microvolts] - Rest test

    Examination of the electrical activity of the masseter muscle at rest (Rest Test): the test will be performed on relaxed and relaxed patients. The dental arches remained slightly open during the examination. In order to eliminate the registration of signals related to the electrical activity of the eye circular muscle, these persons had their eyelids closed during the measurements. The patients were instructed not to swallow saliva during the examination and to place their tongue in a resting position. The SEMG values obtained were normalized as the ratio of RLX to MVC.

    Activity normalized to MVC [%] = Relax - RLX [µV]/ MVC [µV] x 100%

    SEMG recordings from the masseter muscles will be performed with a two-channel NeuroTrac MyoPlus 2 device with NeuroTrac software (Verity Medical Ltd., Tagoat, Ireland).

    Measured: 10 days

  2. Electromyography surface of masseter muscle [uV] - maximal muscle contraction (MVC)

    Study of the bioelectrical activity of the masseter muscle during maximal muscle contraction (MVC): SEMG signal will be recorded in a sitting position, while clenching the teeth, using the greatest possible force, within 5 seconds. The computer program with which the device cooperated registers the minimum and maximum values and calculates the average values of electric potentials. The SEMG values obtained were normalized as the ratio of RLX to MVC.

    Activity normalized to MVC [%] = RLX [µV]/ MVC [µV] x 100%

    SEMG recordings from the masseter muscles will be performed with a two-channel NeuroTrac MyoPlus 2 device with NeuroTrac software (Verity Medical Ltd., Tagoat, Ireland).

    Measured: 10 days

Timeline

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

  1. First posted16 Nov 2022
  2. Study start20 Nov 2022 (estimated)
  3. Primary completion30 Jan 2023 (estimated)
  4. Study completion30 Mar 2023 (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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619380
Sponsor's protocol ID
KB-0012/102/13
Status last verified
Aug 2022
First submitted
24 Aug 2022
Last updated
16 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kapos FP, Exposto FG, Oyarzo JF, Durham J. Temporomandibular disorders: a review of current concepts in aetiology, diagnosis and management. Oral Surg. 2020 Nov;13(4):321-334. doi: 10.1111/ors.12473. Epub 2020 Jan 25.

    PubMed 34853604
  • von Piekartz H, Schwiddessen J, Reineke L, Armijo-Olivio S, Bevilaqua-Grossi D, Biasotto Gonzalez DA, Carvalho G, Chaput E, Cox E, Fernandez-de-Las-Penas C, Gadotti IC, Gil Martinez A, Gross A, Hall T, Hoffmann M, Julsvoll EH, Karegeannes M, La Touche R, Mannheimer J, Pitance L, Rocabado M, Strickland M, Stelzenmuller W, Speksnijder C, van der Meer HA, Luedke K, Ballenberger N. International consensus on the most useful assessments used by physical therapists to evaluate patients with temporomandibular disorders: A Delphi study. J Oral Rehabil. 2020 Jun;47(6):685-702. doi: 10.1111/joor.12959. Epub 2020 May 4.

    PubMed 32150764
  • Daniela Biasotto-Gonzalez, Fausto Bérzin., Electromyographic study of patients with masticatory muscles disorders, physiotherapeutic treTMJent (massage), Brazilian Journal of Oral Sciences 3(10), 2004.

  • Ravishankar Krishna, Anoop Sharma, Shobhit Agarwal, Sweekriti Mishra, Sanober Khan, Alternative Therapies in the Treatment of Temporomandibular Disorders, Journal of Dental & Oro-facial Research Vol. 15 , 1,2018.

Questions about this trial

What is this clinical trial studying?

A study testing physiotherapy treatment in people with Pain and Temporomandibular Joint Disorders, run by Pomeranian Medical University Szczecin at 1 site in Poland.

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 4 inclusion and 11 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 16 Nov 2022. 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 Poland. 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. 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?

Contact Magdalena Gębska, PhD (914417253, mgebska@pum.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain relief (time frame: 10 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05619380, which also lists 4 linked publications.

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 16 Nov 2022.

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