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.
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
- Conditions the study is for
- Pain, Temporomandibular Joint Disorders, Muscle Hypertonia
- 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.
Poland1 site, 1 recruiting
- Recruiting
Department of Musculoskeletal System Rehabilitation, Pomeranian Medical University
Szczecin
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.
- Conditions
- Pain, Temporomandibular Joint Disorders, Muscle Hypertonia, Myofacial Pain, Analgesia, Musculoskeletal Pain
- 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 group | Role | What they receive |
|---|---|---|
| Physiotherapeutic procedures: auto-therapy (therapeutic exercises) | Active comparator | Specialized 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 comparator | Manual 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 comparator | Manual 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.
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)
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
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.
- First posted16 Nov 2022
- Study start20 Nov 2022 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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 34853604von 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 32150764Daniela 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05619380
- Acronym / sponsor ID
- KB-0012/102/13
- Conditions
- Pain, Temporomandibular Joint Disorders, Muscle Hypertonia, Myofacial Pain, Analgesia, Musculoskeletal Pain
- Keywords
- manual therapy, physiotherapy, therapeutic exercises, masseter muscle, pain, electromyography, range of motion, temporomandibular joint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 20 Nov 2022 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physiotherapeutic procedures: auto-therapy (therapeutic exercises) | Active comparator | Procedure: physiotherapy treatmentSpecialized 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. |
| Physiotherapeutic procedures: manual therapy (massage) and auto-therapy (therapeutic exercises) | Active comparator | Procedure: physiotherapy treatmentManual 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. |
| Physiotherapeutic procedures: manual therapy (PIR) and auto-therapy (therapeutic exercises) | Active comparator | Procedure: physiotherapy treatmentManual 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- myofacial pain
- limited mobility of TMJ
- increased muscle tension
- Female sex
Key exclusion criteria (11 listed)
- earlier splint therapy
- pharmacotherapy
- rheumatic diseases
- metabolic diseases
- fibromyalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physiotherapy treatmentAlso: therapeutic exercisesThree 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. | Procedure or surgery | Physiotherapeutic procedures: auto-therapy (therapeutic exercises), Physiotherapeutic procedures: manual therapy (PIR) and auto-therapy (therapeutic exercises), Physiotherapeutic procedures: manual therapy (massage) and auto-therapy (therapeutic exercises) |
Primary outcome
Pain relief
Time frame: 10 days
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.
2 secondary outcomes
Electromyography surface of masseter muscle [uV- microvolts] - Rest test
Time frame: 10 days
Electromyography surface of masseter muscle [uV] - maximal muscle contraction (MVC)
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.
- Background: PubMed 34853604Kapos 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.
- Background: PubMed 32150764von 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.
- BackgroundDaniela Biasotto-Gonzalez, Fausto Bérzin., Electromyographic study of patients with masticatory muscles disorders, physiotherapeutic treTMJent (massage), Brazilian Journal of Oral Sciences 3(10), 2004.
- BackgroundRavishankar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.