Clinical trial NCT05619380: Effectiveness of Physiotherapy Treatments in Temporomandibular Joint Dysfunction
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Temporomandibular Joint Disorders
Muscle Hypertonia
Myofacial Pain
Analgesia
Musculoskeletal Pain
Craniomandibular Osteopathy
Keywords: manual therapy
physiotherapy
therapeutic exercises
masseter muscle
pain
electromyography
range of motion
temporomandibular joint
Lead sponsor: Pomeranian Medical University Szczecin
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 82
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Pain relief
timeFrame: 10 days
Secondary outcomes:
measure: Electromyography surface of masseter muscle [uV- microvolts] - Rest test
timeFrame: 10 days
measure: Electromyography surface of masseter muscle [uV] - maximal muscle contraction (MVC)
timeFrame: 10 days
Other outcomes:
measure: Measurement of the range of motion (ROM) [mm]
timeFrame: 10 days
measure: Measurement of the range of the lateral movement of the mandible [mm]
timeFrame: 10 days
Locations:
city: Szczecin
country: Poland
facility: Department of Musculoskeletal System Rehabilitation, Pomeranian Medical University
Study officials:
References:
citation: 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.
citation: 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.
citation: Daniela Biasotto-Gonzalez, Fausto Bérzin., Electromyographic study of patients with masticatory muscles disorders, physiotherapeutic treTMJent (massage), Brazilian Journal of Oral Sciences 3(10), 2004.
citation: 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.