- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07403357
Effects of Stomatognathic Alignment Exercise Program in Craniomandibular Dysfunction.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Fatima Memorial Hospital (Oral & Maxillofacial Surgery Department)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male and female with age group of 20-65 years.
- Patients diagnosed with temporomandibular dysfunction
- Individuals with the sedentary life style
- Craniovertebral angle <50 degrees
- Patients who presented with at least one symptom of temporomandibular dysfunction, able to communicate effectively, cooperative with imaging examinations, and able to complete the prescribed treatment and patients with no contraindications for the required examinations or treatments.
Exclusion Criteria:
- Serious musculoskeletal problems of cervical and thoracic spine
- Neurological disease affecting balance and postural control
- Dental prosthesis
- Disc prolapsed
- Previous surgery in TMJ area
- Vertebral artery compromise test
- Cerebrovascular disease
Study Plan
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: Stomatognathic alignment exercise program along with standard physical therapy
Stomatognathic alignment exercise program along with standard treatment.
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Chin Tuck Exercise: Starting position: Supine and standing against a wall. Tuck chin backward over the sternal notch to place the patient's ears in line with the tips of the shoulders. Repetitions: Supine: Ten repetitions of a 10-second hold. Standing against a wall: Two repetitions of a 5-minute hold. Anterior Chest Stretching Exercise: Starting position: Standing against a wall with a flattened back; arms at 45° shoulder abduction with elbow in full extension. Active ROM exercises of neck and TMJ: Starting position: Sitting in a back-supported chair. Neck motions: flexion, extension, lateral flexion, and rotation. TMJ: Mouth opening, lateral excursion, and protrusion. Repetitions: A 10-second hold at the end range of each motion. Two series of ten repetitions for each motion. Standard physiotherapy including hot pack and myofascial release of masticatory muscles. A total of 12 sessions were conducted for 4 weeks with 3 sessions scheduled each week.
Control Group received only standard physiotherapy including hot pack and myofascial release of masticatory muscles.
A total of 12 sessions were conducted for 4 weeks with 3 sessions scheduled each week.
|
|
Active Comparator: Traditional physical therapy
Myofascial release of masticatory muscles and heating pad at cervical.
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Control Group received only standard physiotherapy including hot pack and myofascial release of masticatory muscles.
A total of 12 sessions were conducted for 4 weeks with 3 sessions scheduled each week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Pain Rating Scale
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Numeric Pain Rating Scale is utilized to evaluate pain.
It consists of 11 points, having an overall score ranging from 0 to 10, where; 0 represents no pain, 1 to 3 represents mild pain, 4 to 6 represents moderate pain and 7 to 10 represents the most severe pain.
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From enrollment until the end of treatment at the fourth week.
|
|
Mandibular function impairment questionnaire
Time Frame: From enrollment until the end of treatment at the fourth week.
|
MFIQ is used to evaluate the degree of jaw function impairment in TMJD patients.
Two dimensions and 17 questions make up this questionnaire, which assigns a score ranging from 0 (no problem) to 4 (extreme difficulty or impossible without support) for a certain jaw function.
The "functional capacity" dimension is made up of the first eleven components, whereas the "nutrition" dimension is made up of the next six.
A high degree of jaw function impairment is indicated by a high overall score on the questionnaire.
|
From enrollment until the end of treatment at the fourth week.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ROM Cervical Spine (Felxion)
Time Frame: From enrollment until the end of treatment at the fourth week
|
Changes in cervical spine flexion ROM at baseline and 4th week of intervention was measured using goniometer.
|
From enrollment until the end of treatment at the fourth week
|
|
ROM Cervical Spine (Extension)
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in cervical spine extension ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment until the end of treatment at the fourth week.
|
|
ROM Cervical Spine (Lateral Flexion) Left Side
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in cervical spine lateral flexion on left side ROM at baseline and 4th week of intervention was measured using goniometer.
|
From enrollment until the end of treatment at the fourth week.
|
|
ROM Cervical Spine (Lateral Flexion) Right Side
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in cervical spine lateral flexion on right side ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment until the end of treatment at the fourth week.
|
|
ROM Cervical Spine (Rotation) Left Side
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in cervical spine rotation on left side ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment until the end of treatment at the fourth week.
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ROM Cervical Spine (Rotation) Right Side
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in cervical spine rotation on right side ROM at baseline and 4th week of intervention was measured using goniometer.
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From enrollment until the end of treatment at the fourth week.
|
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ROM temporomandibular joint, mouth opening (Depression)
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in mouth opening ROM at baseline and 4th week of intervention was measured using ruler.
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From enrollment until the end of treatment at the fourth week.
|
|
ROM temporomandibular joint (Protrusion)
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in protrusion ROM at baseline and 4th week of intervention was measured using ruler.
|
From enrollment until the end of treatment at the fourth week.
|
|
ROM temporomandibular joint (Lateral Excursion) Left side
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in lateral excursion on left side ROM at baseline and 4th week of intervention was measured using ruler.
|
From enrollment until the end of treatment at the fourth week.
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ROM temporomandibular joint (Lateral Excursion) Right side
Time Frame: From enrollment until the end of treatment at the fourth week.
|
Changes in lateral excursion on right side ROM at baseline and 4th week of intervention was measured using ruler
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From enrollment until the end of treatment at the fourth week.
|
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Craniovertebral angle
Time Frame: From enrollment until the end of treatment at the fourth week.
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For assessing the severity and alignment of forward head posture by evaluating the position of the head in relation to the trunk.
Changes in craniovertebral angle at baseline and 4th week of intervention was measured using Markus Bader-Software solution.
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From enrollment until the end of treatment at the fourth week.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saba Rafique, MS.OMPT, Riphah International University
Publications and helpful links
General Publications
- Oh DW, Kang TW, Kim SJ. Effect of stomatognathic alignment exercise on temporomandibular joint function and swallowing function of stroke patients with limited mouth opening. J Phys Ther Sci. 2013;25(10):1325-9
- Pundkar S, Patil D, Naqvi W. A Comparative Study on Effectiveness of Rocabado Approach and Conventional Physiotherapy on Pain, ROM and QOL in Patients with TMJ Dysfunction. Journal of Pharmaceutical Research International. 2021;33(58B):201-9
- Byra J, Kulesa-Mrowiecka M, Pihut M. Physiotherapy in hypomobility of temporomandibular joints. Folia Med Cracov. 2020;60(2):123-34
- Oleksy Ł, Kielnar R, Mika A, Jankowicz-Szymańska A, Bylina D, Sołtan J, et al. Impact of Cervical Spine Rehabilitation on Temporomandibular Joint Functioning in Patients with Idiopathic Neck Pain. Biomed Res Int. 2021;2021:6886373
- Yılmaz V, Aras B, Umay E. Temporomandibular Joint Dysfunction and Impaired Stomatognathic Alignment: A Problem Beyond Swallowing in Patients With Stroke. Indian J Otolaryngol Head Neck Surg. 2020;72(3):329-34
- Militi A, Bonanno M, Calabrò RS. It Is Time for a Multidisciplinary Rehabilitation Approach: A Scoping Review on Stomatognathic Diseases in Neurological Disorders. J Clin Med. 2023;12(10)
- de Oliveira-Souza AIS, do Valle Sales LR, de Fontes Coutinho AD, de Oliveira DA, Armijo-Olivo S. Effectiveness of an 8-week neck exercise training on pain, jaw function, and oral health-related quality of life in women with chronic temporomandibular disorders: a randomized controlled trial. J Oral Facial Pain Headache. 2024;38(1):40-51
- Ilhanlı M, Ilhanlı I, Aksakallı S. Effectiveness of Rocabado exercises in patients with rheumatoid arthritis in remission with temporomandibular joint involvement: A randomized-controlled study. Turk J Phys Med Rehabil. 2024;70(3):319-26
- O. W. Conservative Management of Temporomandibular Joint Dysfunction: A Case Report. Journal of Health Directories. 2024;1(1):16-23
- Yu LJ, Yan X, Kim TH. Effects of combined jaw and cervicoscapular exercises on mouth opening and muscle properties in cervical extension type. Sci Rep. 2025;15(1):19049.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/24/0186
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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