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The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain

Primary Purpose

Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Neck Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
physiotherapy
TMJ exercises
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Joint Disorders focused on measuring endurance, functionality, joint range of motion

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medicana HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional physiotherapy methods

temporomandibular joint (TMJ) group

Arm Description

conventional physiotherapy methods

conventional physiotherapy methods and temporomandibular joint mobilization and temporomandibular joint exercises

Outcomes

Primary Outcome Measures

Neck Disability Index
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.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2023
Last Updated
September 1, 2023
Sponsor
Uskudar University
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1. Study Identification

Unique Protocol Identification Number
NCT06005922
Brief Title
The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain
Official Title
Investigation of the Effectiveness of Temporomandibular Joint Mobilization and Exercise on Posture, Endurance and Functionality in Individuals With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
October 20, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Neck Pain, Chronic Pain
Keywords
endurance, functionality, joint range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
temporomandibular joint mobilization and temporomandibular joint exercises
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional physiotherapy methods
Arm Type
Active Comparator
Arm Description
conventional physiotherapy methods
Arm Title
temporomandibular joint (TMJ) group
Arm Type
Experimental
Arm Description
conventional physiotherapy methods and temporomandibular joint mobilization and temporomandibular joint exercises
Intervention Type
Other
Intervention Name(s)
physiotherapy
Intervention Description
ultrasound hotpack electrotherapy joint range of motion exercises isometric neck exercises stretching exercises
Intervention Type
Other
Intervention Name(s)
TMJ exercises
Intervention Description
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
Primary Outcome Measure Information:
Title
Neck Disability Index
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ömer ŞEVGİN
Phone
+905069787535
Email
omer.sevgin@uskudar.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şeyma DELCEOĞLU
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Medicana Hospital
City
Umraniye
State/Province
İstanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Şeyma DELCEOĞLU

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30307636
Citation
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.
Results Reference
background
PubMed Identifier
8118901
Citation
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.
Results Reference
background
PubMed Identifier
32723399
Citation
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.
Results Reference
background
PubMed Identifier
31905097
Citation
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.
Results Reference
background
PubMed Identifier
28826164
Citation
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.
Results Reference
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The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain

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