Temporomandibular Joint Dysfunction SyndromeANAISATMNCT05893251
Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction
A study testing Manual therapy and Postural exercises in people with Temporomandibular Joint Dysfunction Syndrome, run by Universidad de Murcia at 1 site in Spain.
Trial summary
Temporomandibular dysfunction (TMD) consists of a series of multifactorial signs and symptoms that occur in the orofacial region, with pain being the most common symptom. There is a close biomechanical and anatomical relationship between the cervical region and the temporomandibular joint (TMJ) through the… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Temporomandibular Joint Dysfunction Syndrome
- What is being tested?
- Manual therapy and Postural exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2017to 1 Jun 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Acceptance of written informed consent.
- Playing a wind instrument.
- Age between 18-40 years.
- Pain in the cranio-cervico-mandibular region and/or masticatory muscles.
- Hypertrophy in the masticatory muscles.
Who cannot join
- History of trauma and/or fracture in the cranial and/or facial region.
- Rheumatic injury or degenerative disease.
- Surgical intervention on the temporomandibular joint (TMJ).
- Malformations of the cervical or cranial spine.
- Vestibular, circulatory, or neurological disorders.
- Degenerative or infectious joint diseases.
- Current orthodontic treatment.
- Receiving physiotherapy treatment during the two weeks prior to the study or during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Temporomandibular dysfunction (TMD) consists of a series of multifactorial signs and symptoms that occur in the orofacial region, with pain being the most common symptom. There is a close biomechanical and anatomical relationship between the cervical region and the temporomandibular joint (TMJ) through the trigemino-spinal nucleus.
Objectives: To comparatively assess the improvement in subjects with TMD when adding cervical manual therapy to a postural treatment. Additionally, to determine if both cervical treatments separately produce changes in the TMJ.
Materials and methods: An experimental study of randomized controlled clinical trial type was conducted. The study involved 30 wind instrument players randomly assigned to an experimental group (EG) and a control group (CG). After obtaining consent, measurements were taken for maximum mouth opening (MMO), cervical range of motion, and pain threshold to pressure (PTP) in the masseter and temporalis muscles. Both groups underwent active cervical postural treatment for 4 weeks, and the EG additionally received a cervical manual therapy protocol. An initial assessment was conducted before the intervention, and a final assessment was done one week after the last intervention. The statistical program SPSS was used for data analysis.
- Being tested
- Manual therapy, Postural exercises
- Keywords
- TEMPOROMANDIBULAR JOINT, Cervical Posture, wind Musician
- Medical subject headings
- Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapyOther
Within the manual therapy protocol carried out in the experimental group, we performed a series of passive maneuvers. The patient remains in supine position on a treatment table throughout the treatment, while the therapist sits at the head of the patient on a stool. The sequence of application is as follows:
Suboccipital inhibition technique Cervical spinal mobilization Posterior fascia stretching
Postural exercisesOther
The treatment plan includes active postural exercises for the cervical spine.
| Study group | Role | What they receive |
|---|---|---|
| Protocol group | Active comparator | The treatment plan includes active postural exercises for the cervical spine. Receives: Other: Postural exercises |
| Manual therapy group | Experimental | The treatment plan includes active postural exercises and manual therapy for the cervical spine. Receives: Other: Manual therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranio facial pain and disability inventory
CF-PDI (Craniofacial Pain and Disability Inventory): This questionnaire focuses on pain as a common symptom of TMD (Temporomandibular Disorders). It is self-administered and designed to assess patients' perception of their physical and psychosocial health in relation to craniofacial pain. It consists of 21 questions regarding the impact of pain on activities involving the use of the temporomandibular joint, with a scoring range from 0 to 63 in ascending order, where 0 indicates no impact and 63 indicates maximum impact. This questionnaire demonstrates good structure, internal consistency, reproducibility, and validity, making it an objective tool that can be used in research and clinical practice for evaluating patients with craniofacial pain and disability. It is easy to administer and requires a short amount of time. The CF-PDI was created and developed in Spain, based on a biopsychosocial approach.
Measured: a week after treatment
Secondary outcomes (1)
Maximum mouth opening.
The measurement of maximum mouth opening (MMO) is the distance in centimeters between the upper and lower incisor teeth when the subject actively opens their mouth.
Measured: a week after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Nov 2017
- Primary completion1 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint Dysfunction SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The present study is an experimental, analytical, longitudinal, and prospective controlled randomized clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893251
- Sponsor's protocol ID
- ANAISATM
- Other IDs
- ANAISATM
- Acronym
- ANAISATM
- Status last verified
- Mar 2018
- First submitted
- 29 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lopez Requena A, Bano Alcaraz A, Escolar Reina P, Ferrandez Gomez E, Canovas Ambit G. Effectiveness of a cervical treatment in wind-instrument musicians with temporomandibular dysfunction: A randomized clinical trial. J Bodyw Mov Ther. 2024 Oct;40:1867-1873. doi: 10.1016/j.jbmt.2024.10.060. Epub 2024 Oct 19.
PubMed 39593537
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction
- ClinicalTrials.gov ID
- NCT05893251
- Acronym / sponsor ID
- ANAISATM / ANAISATM
- Keywords
- TEMPOROMANDIBULAR JOINT, Cervical Posture, wind Musician
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad de MurciaUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 7 Jun 2023 (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.
Temporomandibular dysfunction (TMD) consists of a series of multifactorial signs and symptoms that occur in the orofacial region, with pain being the most common symptom. There is a close biomechanical and anatomical relationship between the cervical region and the temporomandibular joint (TMJ) through the trigemino-spinal nucleus.
Objectives: To comparatively assess the improvement in subjects with TMD when adding cervical manual therapy to a postural treatment. Additionally, to determine if both cervical treatments separately produce changes in the TMJ.
Materials and methods: An experimental study of randomized controlled clinical trial type was conducted. The study involved 30 wind instrument players randomly assigned to an experimental group (EG) and a control group (CG). After obtaining consent, measurements were taken for maximum mouth opening (MMO), cervical range of motion, and pain threshold to pressure (PTP) in the masseter and temporalis muscles. Both groups underwent active cervical postural treatment for 4 weeks, and the EG additionally received a cervical manual therapy protocol. An initial assessment was conducted before the intervention, and a final assessment was done one week after the last intervention. The statistical program SPSS was used for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The present study is an experimental, analytical, longitudinal, and prospective controlled randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Protocol group | Active comparator | Other: Postural exercisesThe treatment plan includes active postural exercises for the cervical spine. |
| Manual therapy group | Experimental | Other: Manual therapyThe treatment plan includes active postural exercises and manual therapy for the cervical spine. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Acceptance of written informed consent.
- Playing a wind instrument.
- Age between 18-40 years.
- Pain in the cranio-cervico-mandibular region and/or masticatory muscles.
- Hypertrophy in the masticatory muscles.
Key exclusion criteria (8 listed)
- History of trauma and/or fracture in the cranial and/or facial region.
- Rheumatic injury or degenerative disease.
- Surgical intervention on the temporomandibular joint (TMJ).
- Malformations of the cervical or cranial spine.
- Vestibular, circulatory, or neurological disorders.
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 therapyWithin the manual therapy protocol carried out in the experimental group, we performed a series of passive maneuvers. The patient remains in supine position on a treatment table throughout the treatment, while the therapist sits at the head of the patient on a stool. The sequence of application is as follows: Suboccipital inhibition technique Cervical spinal mobilization Posterior fascia stretching | Other | Manual therapy group |
| Postural exercisesThe treatment plan includes active postural exercises for the cervical spine. | Other | Protocol group |
Primary outcome
Cranio facial pain and disability inventory
Time frame: a week after treatment
CF-PDI (Craniofacial Pain and Disability Inventory): This questionnaire focuses on pain as a common symptom of TMD (Temporomandibular Disorders). It is self-administered and designed to assess patients' perception of their physical and psychosocial health in relation to craniofacial pain. It consists of 21 questions regarding the impact of pain on activities involving the use of the temporomandibular joint, with a scoring range from 0 to 63 in ascending order, where 0 indicates no impact and 63 indicates maximum impact. This questionnaire demonstrates good structure, internal consistency, reproducibility, and validity, making it an objective tool that can be used in research and clinical practice for evaluating patients with craniofacial pain and disability. It is easy to administer and requires a short amount of time. The CF-PDI was created and developed in Spain, based on a biopsychosocial approach.
1 secondary outcome
Maximum mouth opening.
Time frame: a week after treatment
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 12 Jun 2023.
- Derived from this study: PubMed 39593537Lopez Requena A, Bano Alcaraz A, Escolar Reina P, Ferrandez Gomez E, Canovas Ambit G. Effectiveness of a cervical treatment in wind-instrument musicians with temporomandibular dysfunction: A randomized clinical trial. J Bodyw Mov Ther. 2024 Oct;40:1867-1873. doi: 10.1016/j.jbmt.2024.10.060. Epub 2024 Oct 19.
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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 and Postural exercises in people with Temporomandibular Joint Dysfunction Syndrome, run by Universidad de Murcia 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 5 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 12 Jun 2023. 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?
Cranio facial pain and disability inventory (time frame: a week after treatment). 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 NCT05893251, which also lists 1 linked publication.
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 12 Jun 2023.