Temporomandibular Joint DisordersNCT06005922
The Effectiveness of Temporomandibular Joint Mobilization and Exercise in Individuals With Chronic Neck Pain
A study testing physiotherapy and TMJ exercises in people with Temporomandibular Joint Disorders and Temporomandibular Joint Dysfunction Syndrome, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Neck Pain
- What is being tested?
- physiotherapy and TMJ exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 3 Dec 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Neck Pain, Chronic Pain
- Being tested
- physiotherapy, TMJ exercises
- Keywords
- endurance, functionality, joint range of motion
- Medical subject headings
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Neck Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapyOther
ultrasound hotpack electrotherapy joint range of motion exercises isometric neck exercises stretching exercises
TMJ exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| conventional physiotherapy methods | Active comparator | conventional physiotherapy methods Receives: Other: physiotherapy |
| temporomandibular joint (TMJ) group | Experimental | conventional physiotherapy methods and temporomandibular joint mobilization and temporomandibular joint exercises Receives: Other: physiotherapy; Other: TMJ exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Sep 2023
- Primary completion20 Oct 2023
- Study completion3 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DisordersStudies 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
- temporomandibular joint mobilization and temporomandibular joint exercises
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Öğr. Üyesi Ömer Şevgin, Uskudar University
- Investigators
- Şeyma DELCEOĞLU, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005922
- Sponsor's protocol ID
- Uskudar63
- Status last verified
- Jun 2024
- First submitted
- 16 Aug 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30307636McCarty 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.
PubMed 8118901Bernal-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.
PubMed 32723399Reynolds 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.
PubMed 31905097Hidalgo 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.
PubMed 28826164Delceoglu S, Safran EE, Sevgin O, Safran E. Multiregional Rehabilitation Targeting the Cervical and Temporomandibular Regions in Chronic Neck Pain: A Randomized Controlled Trial. Physiother Res Int. 2026 Apr;31(2):e70216. doi: 10.1002/pri.70216.
PubMed 41954133
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Temporomandibular Joint Mobilization and Exercise on Posture, Endurance and Functionality in Individuals With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06005922
- Acronym / sponsor ID
- Uskudar63
- Conditions
- Temporomandibular Joint Disorders, Temporomandibular Joint Dysfunction Syndrome, Neck Pain, Chronic Pain
- Keywords
- endurance, functionality, joint range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 20 Oct 2023 (actual)
- Study completion
- 3 Dec 2023 (actual)
- First posted
- 23 Aug 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- temporomandibular joint mobilization and temporomandibular joint exercises
| Arm | Type | Receives |
|---|---|---|
| conventional physiotherapy methods | Active comparator | Other: physiotherapyconventional physiotherapy methods |
| temporomandibular joint (TMJ) group | Experimental | Other: physiotherapy, Other: TMJ exercisesconventional physiotherapy methods and temporomandibular joint mobilization and temporomandibular joint exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| physiotherapyultrasound hotpack electrotherapy joint range of motion exercises isometric neck exercises stretching exercises | Other | conventional physiotherapy methods, temporomandibular joint (TMJ) group |
| TMJ exercisestongue 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 | Other | temporomandibular joint (TMJ) group |
Primary outcome
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.
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 11 Jun 2024.
- Background: PubMed 30307636Calixtre 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.
- Background: PubMed 8118901McCarty 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.
- Background: PubMed 32723399Bernal-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.
- Background: PubMed 31905097Reynolds 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.
- Background: PubMed 28826164Hidalgo 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.
- Derived from this study: PubMed 41954133Delceoglu S, Safran EE, Sevgin O, Safran E. Multiregional Rehabilitation Targeting the Cervical and Temporomandibular Regions in Chronic Neck Pain: A Randomized Controlled Trial. Physiother Res Int. 2026 Apr;31(2):e70216. doi: 10.1002/pri.70216.
- Individual participant dataSharing planned: No
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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.
Şeyma DELCEOĞLU study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapy and TMJ exercises in people with Temporomandibular Joint Disorders and Temporomandibular Joint Dysfunction Syndrome, run by Uskudar University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 11 Jun 2024. 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 Turkey (Türkiye). 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?
Neck Disability Index (time frame: 6 weeks). 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 NCT06005922, which also lists 6 linked publications.
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 11 Jun 2024.