Effectiveness of Physiotherapy Treatments in Temporomandibular Joint Dysfunction

Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05619380
• Other study ID #: KB-0012/102/13
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: August 2022
• Source: Pomeranian Medical University Szczecin
• Contact: Magdalena Gebska, PhD
• Phone: 914417253
• Email: mgebska[@]pum.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: March 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Facial Pain
• Joint Diseases
• Muscle Hypertonia
• Musculoskeletal Pain
• Myofacial Pain
• Pain
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• physiotherapy treatment
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.

Locations

Country	Name	City	State
Poland	Department of Musculoskeletal System Rehabilitation, Pomeranian Medical University	Szczecin

Sponsors (1)

Lead Sponsor	Collaborator
Pomeranian Medical University Szczecin

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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

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. — View 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.

von Piekartz H, Schwiddessen J, Reineke L, Armijo-Olivio S, Bevilaqua-Grossi D, Biasotto Gonzalez DA, Carvalho G, Chaput E, Cox E, Fernández-de-Las-Peñas C, Gadotti IC, Gil Martínez A, Gross A, Hall T, Hoffmann M, Julsvoll EH, Karegeannes M, La Touche R, Mannheimer J, Pitance L, Rocabado M, Strickland M, Stelzenmüller 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measurement of the range of motion (ROM) [mm]	Measurement of the range of mobility of the maximum abduction of the mandible (linear measurement from in mm. the upper to the lower incisor). The average value of all measurements will be analyzed.	10 days
Other	Measurement of the range of the lateral movement of the mandible [mm]	Measurement of the range of mobility of the lateral movements of the mandible. The average value of all measurements will be analyzed.	10 days
Primary	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.	10 days
Secondary	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).	10 days
Secondary	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).	10 days