Temporomandibular Dysfunction (TMD)MT-ATMNCT03555201
Efficacy of Physiotherapy in Patients With Temporomandibular Disorders.
A study testing Manual therapy in people with Temporomandibular Dysfunction (TMD), run by University of Valencia at 1 site in Spain.
Trial summary
Objective: To evaluate the efficacy of a manual therapy protocol composed of articulatory and myofascial techniques in patients with temporomandibular dysfunction (TMD). Methods: Randomized and controlled clinical study of patients presenting TMD. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Dysfunction (TMD)
- What is being tested?
- Manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 31 May 2018to 15 Aug 2018
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with TMD or myofascial pain according to the Helkimo index.
- Use of the discharge splint, except in the 2 weeks prior to the study.
- Age of the subjects between 18 and 65 years old.
- Presence of TMD signs and symptoms in the 3 months prior to the study, such as limitations in movements, pain and / or deviation during opening of the mouth, muscular sensitivity, and sounds produced by the joint during opening of the mouth.
- Limitation of active vertical opening of the mouth <40 mm.
- Bilateral pain that surrounds the areas of the temporal and the masseter.
- Presence of at least one trigger point in the masseter and temporal muscles.
- Patients who sign the informed consent.
Who cannot join
- That they did not use the splint, except in the 2 weeks prior to the study.
- Presence of systemic, rheumatic or central nervous system diseases.
- Trauma or previous surgical intervention in the ATM region.
- History of some type of treatment (physiotherapy or acupuncture) in the 3 months prior to the study.
- Use of analgesics or muscle relaxants at least 24 hours before the evaluations and during the treatment period.
- Presence of another type of orofacial pain disorder.
- Presence of signs or symptoms of disc displacement, osteoarthritis or TMJ arthritis.
- Positive extension-rotation test (vertebral artery test or Klein test) or cerebrovascular changes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Physiotherapy Protocol Based on Manual Therapy in Patients With Temporomandibular Disorders.
Objective: To evaluate the efficacy of a manual therapy protocol composed of articulatory and myofascial techniques in patients with temporomandibular dysfunction (TMD).
Methods: Randomized and controlled clinical study of patients presenting TMD. The subjects will be divided into 2 groups: 1) manual therapy group; 2) control group. There will be 4 treatment sessions during 4 weeks, with evaluations before and after the study, which include: severity of dysfunction (Helkimo Index), quality of life (Short Form 36 Health Survey), pressure pain threshold (algometer) ), cervical mobility (goniometer), mouth opening (caliper), pain intensity (Visual Analogue Scale) and cervical disability (Neck Disability Index).
Read the detailed description
Introduction. Temporomandibular dysfunction (TMD) is the set of clinical manifestations that affect this joint, the masticatory muscles and the structures associated with and involved in TMJ movements. This dysfunction represents a subclassification of musculoskeletal disorders, and presents with different symptoms and signs that include pain in the jaw joint or in the tissues that surround it, generalized myofascial pain, crackling or crackling joint noise associated with the movement, decrease in joint range, functional limitation, and deviation to the opening of the jaw.
Objective. The main objective of this study is to compare the efficacy of a myofascial soft tissue treatment versus a control group in people diagnosed with TMD of myofascial origin.
Material and methods
Sample. Subjects with dagnosis of TMD according to the diagnostic criteria for the investigation of temporomandibular disorders.
Study design. Randomized clinical trial with 2 groups: Group 1. Manual therapy protocol of SOFT TISSUES; Group 2. Regular treatment control.
Evaluations. Clinical interview with anthropometric data and characteristics of the pathology.
There will be 3 evaluations: at the beginning of the study, at the end of the treatment (at 4 weeks) and at 8 weeks as part of the follow-up period.
In addition, it includes the following evaluation instruments:
- Visual Analog Scale (EVA)
- Algometry of the masseter, temporal and ECOM muscles.
- Oral opening range.
- Range of cervical joint movement.
- Quality of life questionnaire related to oral health OHIP-14.
- Quality of life questionnaire SF-36.
- Index of clinical dysfunction of Helkimo.
- Cervical disability index.
- Conditions
- Temporomandibular Dysfunction (TMD)
- Being tested
- Manual therapy, Regular treatment control.
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
protocol of soft tissues techniques
Regular treatment control.Other
Regular treatment control.
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy | Experimental | Protocol of soft tissue techniques Receives: Other: Regular treatment control. |
| Regular treatment control. | Active comparator | Regular treatment control. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Pain intensity scale. This scale consists of a horizontal line of 100 mm, delimited at one end by 0 mm (no pain) and at the other end by 100 mm (worst pain imaginable). This scale has shown a high validity and reliability for the assessment of the pain intensity of the patient
Measured: 8 weeks
Secondary outcomes (6)
Severity and degree of dysfunction
Helkimo Index. This index is based on the evaluation of five clinical signs: 1. Alteration of the range of movement by measuring the amplitude of the movements of the jaw: opening, lateralisation and protrusion of the jaw; 2. Alteration of the TMJ function (appearance of sounds in the joint during the vertical opening of the mouth, and mandibular trajectory pattern); 3. Muscle pain; 4. Pain upon palpation of the TMJ; 5. Pain during the movement of the jaw38. Each item evaluated is scored with values of 0, 1 or 5, with the sum of the scores of the clinical signs evaluated, the one referring to describing the severity and the group for each patient with TMD41. If the score obtained is 0, patients are included in group 0 (absence of symptoms). Scores from 1 to 4, group 1 (mild dysfunction). Scores from 5 to 9, group 2 (moderate dysfunction). And finally, if the score is from 10 to 25, the patients belong to group 3 (severe dysfunction).
Measured: 8 weeks
Health status
Quality of life questionnaire. The SF-36v2 is composed of 36 items with Likert type response options, which are included in 8 dimensions: Physical Function (FF, 10 items), Physical Role (RF, 4 items), Body Pain (DC, 2 items) , General Health (SG, 6 items), Vitality (VT, 4 items), Social Function (FS, 2 items), Emotional Role (SR, 3 items) and Mental Health (SM, 5 items). The scores range from 0 to 100 in each dimension, with the highest scores associated with a better state of health. This questionnaire has demonstrated a high internal consistency with a Cronbach's alpha value of more than 0.70, and an adequate reliability (ICC = 0.73-0'86).
Measured: 8 weeks
Cervical disability
Cervical disability questionnaire (NDI). It is a self-completed questionnaire formed by 10 sections: cervical pain intensity, personal care, weight lifting, reading, headache, concentration ability, work capacity, driving, sleep and leisure activities. The scores for each section range from 0 to 5, being 0 (without disability) and 5 (total disability). If a score ranges from 0 to 4, the patient would not have cervical disability. Scores from 5 to 14 (mild disability), from 15 to 24 (moderate disability), from 25 to 34 (severe disability) and from 35 to 50 (complete disability). Therefore, the maximum score that can be reached in this questionnaire is 509.45. The test-retest reliability has been shown to be optimal with an intraclass correlation coefficient of 0.978, and a high internal consistency with a Cronbach's alpha coefficient of 0.937.
Measured: 8 weeks
Opening range of the mouth
Vernier caliper. To measure the active opening of the mouth without pain a vernier caliper will be used (Vernier Caliper). To do this, patients remain in a sitting position and are asked to perform a maximum opening of the mouth without pain. The distance between the upper and lower central incisors of the mandible is measured, using the millimeters as the unit of measurement. 3 consecutive measurements are made with rest intervals of 30 seconds. The final measurement is obtained based on the average of the 3 results belonging to the previous measurements. This procedure has shown high intra-rater reliability (ICC = 0'9-0'98).
Measured: 8 weeks
Pressure pain threshold
Algometer. To assess the pain threshold at the pressure of the masseter, temporal and ECOM muscles, a mechanical pressure algometer (Wagner Instruments FDK 20) will be used. The pressure pain threshold is the minimum pressure that is needed to cause pain or discomfort at a certain point. In obtaining the result, the average of the 3 scores obtained from each point was made. The reliability of this procedure is high in healthy subjects [BCI = 0.91 (95% confidence interval: 0.82-0.97)] 28.31. In patients with TMD, reliability is moderate (ICC = 0.64)
Measured: 8 weeks
Cervical mobility
Goniometer. The range of joint movement of the neck is measured by the use of a goniometer. Flexion, extension, lateral tilt and cervical rotation are assessed. To be able to perform the measurement, the patient is asked to remain in a sitting position keeping his back at 90 degrees and his head in a neutral position. The physiotherapist instructs the patients to perform the previously explained movements, until reaching the maximum range of movement or in the presence of pain. We proceed to evaluate mobility in the 3 planes: sagittal plane, frontal plane and transverse plane. 3 measurements of each movement are made, and the final measurement obtained is the average of each previous result.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start31 May 2018
- Primary completion31 Jul 2018
- Study completion15 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Dysfunction (TMD)Studies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555201
- Sponsor's protocol ID
- ID0022
- Acronym
- MT-ATM
- Status last verified
- Oct 2019
- First submitted
- 31 May 2018
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Physiotherapy Protocol Based on Manual Therapy in Patients With Temporomandibular Disorders.
- ClinicalTrials.gov ID
- NCT03555201
- Acronym / sponsor ID
- MT-ATM / ID0022
- Conditions
- Temporomandibular Dysfunction (TMD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 31 May 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 13 Jun 2018 (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.
Objective: To evaluate the efficacy of a manual therapy protocol composed of articulatory and myofascial techniques in patients with temporomandibular dysfunction (TMD).
Methods: Randomized and controlled clinical study of patients presenting TMD. The subjects will be divided into 2 groups: 1) manual therapy group; 2) control group. There will be 4 treatment sessions during 4 weeks, with evaluations before and after the study, which include: severity of dysfunction (Helkimo Index), quality of life (Short Form 36 Health Survey), pressure pain threshold (algometer) ), cervical mobility (goniometer), mouth opening (caliper), pain intensity (Visual Analogue Scale) and cervical disability (Neck Disability Index).
Detailed description
Introduction. Temporomandibular dysfunction (TMD) is the set of clinical manifestations that affect this joint, the masticatory muscles and the structures associated with and involved in TMJ movements. This dysfunction represents a subclassification of musculoskeletal disorders, and presents with different symptoms and signs that include pain in the jaw joint or in the tissues that surround it, generalized myofascial pain, crackling or crackling joint noise associated with the movement, decrease in joint range, functional limitation, and deviation to the opening of the jaw.
Objective. The main objective of this study is to compare the efficacy of a myofascial soft tissue treatment versus a control group in people diagnosed with TMD of myofascial origin.
Material and methods
Sample. Subjects with dagnosis of TMD according to the diagnostic criteria for the investigation of temporomandibular disorders.
Study design. Randomized clinical trial with 2 groups: Group 1. Manual therapy protocol of SOFT TISSUES; Group 2. Regular treatment control.
Evaluations. Clinical interview with anthropometric data and characteristics of the pathology.
There will be 3 evaluations: at the beginning of the study, at the end of the treatment (at 4 weeks) and at 8 weeks as part of the follow-up period.
In addition, it includes the following evaluation instruments:
- Visual Analog Scale (EVA)
- Algometry of the masseter, temporal and ECOM muscles.
- Oral opening range.
- Range of cervical joint movement.
- Quality of life questionnaire related to oral health OHIP-14.
- Quality of life questionnaire SF-36.
- Index of clinical dysfunction of Helkimo.
- Cervical disability index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy | Experimental | Other: Regular treatment control.Protocol of soft tissue techniques |
| Regular treatment control. | Active comparator | Other: Manual therapyRegular treatment control. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients with TMD or myofascial pain according to the Helkimo index.
- Use of the discharge splint, except in the 2 weeks prior to the study.
- Age of the subjects between 18 and 65 years old.
- Presence of TMD signs and symptoms in the 3 months prior to the study, such as limitations in movements, pain and / or deviation during opening of the mouth, muscular sensitivity, and sounds produced by the joint during opening of the mouth.
- Limitation of active vertical opening of the mouth <40 mm.
Key exclusion criteria (8 listed)
- That they did not use the splint, except in the 2 weeks prior to the study.
- Presence of systemic, rheumatic or central nervous system diseases.
- Trauma or previous surgical intervention in the ATM region.
- History of some type of treatment (physiotherapy or acupuncture) in the 3 months prior to the study.
- Use of analgesics or muscle relaxants at least 24 hours before the evaluations and during the treatment period.
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 |
|---|---|---|
| Manual therapyprotocol of soft tissues techniques | Other | Regular treatment control. |
| Regular treatment control.Regular treatment control. | Other | Manual therapy |
Primary outcome
Intensity of pain
Time frame: 8 weeks
Pain intensity scale. This scale consists of a horizontal line of 100 mm, delimited at one end by 0 mm (no pain) and at the other end by 100 mm (worst pain imaginable). This scale has shown a high validity and reliability for the assessment of the pain intensity of the patient
6 secondary outcomes
Severity and degree of dysfunction
Time frame: 8 weeks
Health status
Time frame: 8 weeks
Cervical disability
Time frame: 8 weeks
Opening range of the mouth
Time frame: 8 weeks
Pressure pain threshold
Time frame: 8 weeks
Cervical mobility
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy in people with Temporomandibular Dysfunction (TMD), run by University of Valencia at 1 site in Spain.
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 8 inclusion and 8 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: finished, as of the sponsor's last update on 9 Oct 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: 8 weeks). 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 9 Oct 2019.