- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05893251
Effectiveness of Cervical Treatment in Wind Musicians With Temporomandibular Dysfunction (ANAISATM)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Murcia, Spain, 30120
- University of Murcia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Protocol group
The treatment plan includes active postural exercises for the cervical spine.
|
The treatment plan includes active postural exercises for the cervical spine.
|
|
Experimental: Manual therapy group
The treatment plan includes active postural exercises and manual therapy for the cervical spine.
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
a week after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum mouth opening.
Time Frame: a week after treatment
|
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.
|
a week after treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain pressure threshold in myofascial trigger points of the masticatory muscles.
Time Frame: a week after treatment
|
In TMD, myofascial pain of the masticatory muscles is the most relevant clinical entity that affects the masticatory system.
It will be measured using a pressure algometer.
|
a week after treatment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANAISATM (Other Identifier: UNIVERSITY OF MURCIA)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.