NCT06005922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2023

Completed
Last Updated

June 11, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

August 16, 2023

Last Update Submit

June 10, 2024

Conditions

Keywords

endurancefunctionalityjoint range of motion

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Study Arms (2)

conventional physiotherapy methods

ACTIVE COMPARATOR

conventional physiotherapy methods

Other: physiotherapy

temporomandibular joint (TMJ) group

EXPERIMENTAL

conventional physiotherapy methods and temporomandibular joint mobilization and temporomandibular joint exercises

Other: physiotherapyOther: TMJ exercises

Interventions

ultrasound hotpack electrotherapy joint range of motion exercises isometric neck exercises stretching exercises

conventional physiotherapy methodstemporomandibular joint (TMJ) group

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

temporomandibular joint (TMJ) group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medicana Hospital

Umraniye, Istanbul, Turkey (Türkiye)

Location

Related Publications (5)

  • 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.

    PMID: 30307636BACKGROUND
  • 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.

    PMID: 8118901BACKGROUND
  • 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.

    PMID: 32723399BACKGROUND
  • 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.

    PMID: 31905097BACKGROUND
  • 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.

    PMID: 28826164BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersTemporomandibular Joint Dysfunction SyndromeNeck PainChronic Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesMyofascial Pain SyndromesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Şeyma DELCEOĞLU

    Uskudar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: temporomandibular joint mobilization and temporomandibular joint exercises
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 23, 2023

Study Start

September 1, 2023

Primary Completion

October 20, 2023

Study Completion

December 3, 2023

Last Updated

June 11, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations