- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06005922
The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain
December 6, 2023 updated by: Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
Investigation of the Effectiveness of Temporomandibular Joint Mobilization and Exercise on Posture, Endurance and Functionality in Individuals With Chronic Neck Pain
To examine the effects of temporomandibular joint mobilization and exercises added to the conventional physiotherapy program on posture, functionality and muscular endurance in individuals with chronic neck pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our research is a randomized controlled trial.
50 participants will be included in the study, which will be conducted on individuals aged 18-65 years with chronic neck pain.
Participants will be divided into 2 groups as experimental and control groups by simple randomization method.
All patients will be treated with conventional physiotherapy methods for 4 weeks and 5 days a week.
In addition to conventional treatment, temporomandibular joint mobilization techniques were applied to the experimental group; exercises will be given.
In the study, temporomandibular dysfunction (TMD) Pain Screener, Neck Disability Index, and Visual Analog Scale questionnaires will be applied to the patients twice, before and after the treatment.
Before and after the treatment, the cervical region's range of motion and muscular endurance will be measured by the physiotherapist.
Pre- and post-intervention data were statistically analyzed and compared.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ömer ŞEVGİN
- Phone Number: +905069787535
- Email: omer.sevgin@uskudar.edu.tr
Study Locations
-
-
İstanbul
-
Umraniye, İstanbul, Turkey
- Medicana Hospital
-
Contact:
- Şeyma DELCEOĞLU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between the ages of 18-65,
- Having neck pain lasting longer than 3 months,
- Absence of known systemic disease or trauma history,
- Volunteering to participate in the research.
Exclusion Criteria:
- Having a history of trauma in the areas that are the subject of the study, such as head and neck surgery, upper extremity, thoracic and cervical vertebrae,
- Disc displacement, osteoarthrosis, osteoarthritis signs and symptoms
- Having a neurological-psychiatric diagnosis that may affect the measurement results.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: temporomandibular joint (TMJ) group
conventional physiotherapy methods and temporomandibular joint mobilization and temporomandibular joint exercises
|
ultrasound hotpack electrotherapy joint range of motion exercises isometric neck exercises stretching exercises
tongue relaxation position TMJ isometric strengthening exercises Posture exercises Isometric neck extension in neutral position back extension Strengthening the abdominal muscles Supine dorsal stretch pectoral stretch
|
Active Comparator: conventional physiotherapy methods
|
ultrasound hotpack electrotherapy joint range of motion exercises isometric neck exercises stretching exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index
Time Frame: 6 weeks
|
The survey consists of 10 questions.
Each question has 5 options.
For each question, points are given as A:0, B:1, C:2 D:3 E:4, F:4.
0-4 points are defined as no disability, 5-14 points as mild disability, 15-24 points as moderate disability, 25-34 points as severe disability, 35 or above points as complete disability.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Şeyma DELCEOĞLU, Uskudar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Calixtre LB, Oliveira AB, de Sena Rosa LR, Armijo-Olivo S, Visscher CM, Alburquerque-Sendin F. Effectiveness of mobilisation of the upper cervical region and craniocervical flexor training on orofacial pain, mandibular function and headache in women with TMD. A randomised, controlled trial. J Oral Rehabil. 2019 Feb;46(2):109-119. doi: 10.1111/joor.12733. Epub 2018 Oct 26.
- Hidalgo B, Hall T, Bossert J, Dugeny A, Cagnie B, Pitance L. The efficacy of manual therapy and exercise for treating non-specific neck pain: A systematic review. J Back Musculoskelet Rehabil. 2017 Nov 6;30(6):1149-1169. doi: 10.3233/BMR-169615.
- Bernal-Utrera C, Gonzalez-Gerez JJ, Anarte-Lazo E, Rodriguez-Blanco C. Manual therapy versus therapeutic exercise in non-specific chronic neck pain: a randomized controlled trial. Trials. 2020 Jul 28;21(1):682. doi: 10.1186/s13063-020-04610-w.
- McCarty WL Jr, Darnell MW. Rehabilitation of the temporomandibular joint through the application of motion. Cranio. 1993 Oct;11(4):298-307. doi: 10.1080/08869634.1993.11677982.
- Reynolds B, Puentedura EJ, Kolber MJ, Cleland JA. Effectiveness of Cervical Spine High-Velocity, Low-Amplitude Thrust Added to Behavioral Education, Soft Tissue Mobilization, and Exercise for People With Temporomandibular Disorder With Myalgia: A Randomized Clinical Trial. J Orthop Sports Phys Ther. 2020 Aug;50(8):455-465. doi: 10.2519/jospt.2020.9175. Epub 2020 Jan 6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2023
Primary Completion (Actual)
October 20, 2023
Study Completion (Actual)
December 3, 2023
Study Registration Dates
First Submitted
August 16, 2023
First Submitted That Met QC Criteria
August 21, 2023
First Posted (Actual)
August 23, 2023
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
December 6, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Chronic Pain
- Neck Pain
- Joint Diseases
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
Other Study ID Numbers
- Uskudar63
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Vastra Gotaland RegionActive, not recruitingPain, Chronic | Widespread Chronic PainSweden
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, Chronic | Video-Assisted Thoracoscopic SurgeryTurkey
Clinical Trials on physiotherapy
-
Hacettepe UniversityCompleted
-
Manchester Metropolitan UniversityCompleted
-
Rigshospitalet, DenmarkThe Association of Danish Physiotherapists Research Fund, Denmark; The Jubilee...CompletedTrismus | Oropharyngeal Cancer | Oral Cavity Carcinoma | Adverse Effect of Radiation TherapyDenmark
-
University of OviedoCompletedParkinson Disease
-
Isra UniversityCompleted
-
University of Nove de JulhoUniversidade Federal do CearáRecruitingEdema | ParesthesiaBrazil
-
Ambreen ChohanBlackpool Victoria HospitalCompletedKnee Osteoarthritis | Exercise | Rehabilitation | Physiotherapy | InterventionUnited Kingdom
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceTerminated
-
Centre Hospitalier Universitaire de Saint EtienneCompleted