Craniomandibular DysfunctionNCT07403357
Effects of Stomatognathic Alignment Exercise Program in Craniomandibular Dysfunction.
A study testing Stomatognathic Alignment Exercise Program and Standard Physical therapy treatment in people with Craniomandibular Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
The study was conducted to determine the effects of stomatognathic alignment exercise program in craniomandibular dysfunction. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Craniomandibular Dysfunction
- What is being tested?
- Stomatognathic Alignment Exercise Program and Standard Physical therapy treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 30 Nov 2025
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Fatima Memorial Hospital (Oral & Maxillofacial Surgery Department)
Lahore, Punjab Province, 54000
About this study
The study was conducted to determine the effects of stomatognathic alignment exercise program in craniomandibular dysfunction.
- Conditions
- Craniomandibular Dysfunction
- Being tested
- Stomatognathic Alignment Exercise Program, Standard Physical therapy treatment
- Keywords
- functional disability, Temporomandibular joint, Forward head posture, Myofascial release, Stomatognathic Alignment Exercise, Stomatognathic disease, Craniomandibular Dysfunction
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stomatognathic Alignment Exercise ProgramOther
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.
Standard Physical therapy treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Stomatognathic alignment exercise program along with standard physical therapy | Experimental | Stomatognathic alignment exercise program along with standard treatment. Receives: Other: Stomatognathic Alignment Exercise Program; Other: Standard Physical therapy treatment |
| Traditional physical therapy | Active comparator | Myofascial release of masticatory muscles and heating pad at cervical. Receives: Other: Standard Physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
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.
Measured: From enrollment until the end of treatment at the fourth week.
Mandibular function impairment questionnaire
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.
Measured: From enrollment until the end of treatment at the fourth week.
Secondary outcomes (11)
ROM Cervical Spine (Felxion)
Changes in cervical spine flexion ROM at baseline and 4th week of intervention was measured using goniometer.
Measured: From enrollment until the end of treatment at the fourth week
ROM Cervical Spine (Extension)
Changes in cervical spine extension ROM at baseline and 4th week of intervention was measured using goniometer.
Measured: From enrollment until the end of treatment at the fourth week.
ROM Cervical Spine (Lateral Flexion) Left Side
Changes in cervical spine lateral flexion on left side ROM at baseline and 4th week of intervention was measured using goniometer.
Measured: From enrollment until the end of treatment at the fourth week.
ROM Cervical Spine (Lateral Flexion) Right Side
Changes in cervical spine lateral flexion on right side ROM at baseline and 4th week of intervention was measured using goniometer.
Measured: From enrollment until the end of treatment at the fourth week.
ROM Cervical Spine (Rotation) Left Side
Changes in cervical spine rotation on left side ROM at baseline and 4th week of intervention was measured using goniometer.
Measured: From enrollment until the end of treatment at the fourth week.
ROM Cervical Spine (Rotation) Right Side
Changes in cervical spine rotation on right side ROM at baseline and 4th week of intervention was measured using goniometer.
Measured: From enrollment until the end of treatment at the fourth week.
ROM temporomandibular joint, mouth opening (Depression)
Changes in mouth opening ROM at baseline and 4th week of intervention was measured using ruler.
Measured: From enrollment until the end of treatment at the fourth week.
ROM temporomandibular joint (Protrusion)
Changes in protrusion ROM at baseline and 4th week of intervention was measured using ruler.
Measured: From enrollment until the end of treatment at the fourth week.
ROM temporomandibular joint (Lateral Excursion) Left side
Changes in lateral excursion on left side ROM at baseline and 4th week of intervention was measured using ruler.
Measured: From enrollment until the end of treatment at the fourth week.
ROM temporomandibular joint (Lateral Excursion) Right side
Changes in lateral excursion on right side ROM at baseline and 4th week of intervention was measured using ruler
Measured: From enrollment until the end of treatment at the fourth week.
Craniovertebral angle
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.
Measured: From enrollment until the end of treatment at the fourth week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Jun 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Craniomandibular DysfunctionStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saba Rafique, MS.OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403357
- Sponsor's protocol ID
- REC/RCR & AHS/24/0186
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 Oct;25(10):1325-9. doi: 10.1589/jpts.25.1325. Epub 2013 Nov 20.
PubMed 24259786Pundkar 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 Sep 28;60(2):123-134.
PubMed 33252600Oleksy L, Kielnar R, Mika A, Jankowicz-Szymanska A, Bylina D, Soltan J, Pruszczynski B, Stolarczyk A, Krolikowska A. Impact of Cervical Spine Rehabilitation on Temporomandibular Joint Functioning in Patients with Idiopathic Neck Pain. Biomed Res Int. 2021 Oct 7;2021:6886373. doi: 10.1155/2021/6886373. eCollection 2021.
PubMed 34660797Yilmaz 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 Sep;72(3):329-334. doi: 10.1007/s12070-020-01830-z. Epub 2020 Mar 9.
PubMed 32728543Militi A, Bonanno M, Calabro RS. It Is Time for a Multidisciplinary Rehabilitation Approach: A Scoping Review on Stomatognathic Diseases in Neurological Disorders. J Clin Med. 2023 May 17;12(10):3528. doi: 10.3390/jcm12103528.
PubMed 37240633de 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 Mar;38(1):40-51. doi: 10.22514/jofph.2024.005. Epub 2024 Mar 12.
PubMed 39788575Ilhanli M, Ilhanli I, Aksakalli 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 Jul 26;70(3):319-326. doi: 10.5606/tftrd.2024.13517. eCollection 2024 Sep.
PubMed 39679114O. 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 May 30;15(1):19049. doi: 10.1038/s41598-025-03846-3.
PubMed 40447683
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Stomatognathic Alignment Exercise Program in Craniomandibular Dysfunction.
- ClinicalTrials.gov ID
- NCT07403357
- Acronym / sponsor ID
- REC/RCR & AHS/24/0186
- Conditions
- Craniomandibular Dysfunction
- Keywords
- functional disability, Temporomandibular joint, Forward head posture, Myofascial release, Stomatognathic Alignment Exercise, Stomatognathic disease, Craniomandibular Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 11 Feb 2026 (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.
The study was conducted to determine the effects of stomatognathic alignment exercise program in craniomandibular dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stomatognathic alignment exercise program along with standard physical therapy | Experimental | Other: Stomatognathic Alignment Exercise Program, Other: Standard Physical therapy treatmentStomatognathic alignment exercise program along with standard treatment. |
| Traditional physical therapy | Active comparator | Other: Standard Physical therapy treatmentMyofascial release of masticatory muscles and heating pad at cervical. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Serious musculoskeletal problems of cervical and thoracic spine
- Neurological disease affecting balance and postural control
- Dental prosthesis
- Disc prolapsed
- Previous surgery in TMJ area
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 |
|---|---|---|
| Stomatognathic Alignment Exercise ProgramChin 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. | Other | Stomatognathic alignment exercise program along with standard physical therapy |
| Standard Physical therapy treatmentControl 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. | Other | Stomatognathic alignment exercise program along with standard physical therapy, Traditional physical therapy |
Primary outcome
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.
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.
11 secondary outcomes
ROM Cervical Spine (Felxion)
Time frame: 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.
ROM Cervical Spine (Lateral Flexion) Left Side
Time frame: 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.
ROM Cervical Spine (Rotation) Left Side
Time frame: From enrollment until the end of treatment at the fourth week.
ROM Cervical Spine (Rotation) Right Side
Time frame: From enrollment until the end of treatment at the fourth week.
ROM temporomandibular joint, mouth opening (Depression)
Time frame: 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.
ROM temporomandibular joint (Lateral Excursion) Left side
Time frame: From enrollment until the end of treatment at the fourth week.
ROM temporomandibular joint (Lateral Excursion) Right side
Time frame: From enrollment until the end of treatment at the fourth week.
Craniovertebral angle
Time frame: From enrollment until the end of treatment at the fourth week.
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 Feb 2026.
- Background: PubMed 24259786Oh 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 Oct;25(10):1325-9. doi: 10.1589/jpts.25.1325. Epub 2013 Nov 20.
- BackgroundPundkar 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
- Background: PubMed 33252600Byra J, Kulesa-Mrowiecka M, Pihut M. Physiotherapy in hypomobility of temporomandibular joints. Folia Med Cracov. 2020 Sep 28;60(2):123-134.
- Background: PubMed 34660797Oleksy L, Kielnar R, Mika A, Jankowicz-Szymanska A, Bylina D, Soltan J, Pruszczynski B, Stolarczyk A, Krolikowska A. Impact of Cervical Spine Rehabilitation on Temporomandibular Joint Functioning in Patients with Idiopathic Neck Pain. Biomed Res Int. 2021 Oct 7;2021:6886373. doi: 10.1155/2021/6886373. eCollection 2021.
- Background: PubMed 32728543Yilmaz 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 Sep;72(3):329-334. doi: 10.1007/s12070-020-01830-z. Epub 2020 Mar 9.
- Background: PubMed 37240633Militi A, Bonanno M, Calabro RS. It Is Time for a Multidisciplinary Rehabilitation Approach: A Scoping Review on Stomatognathic Diseases in Neurological Disorders. J Clin Med. 2023 May 17;12(10):3528. doi: 10.3390/jcm12103528.
- Background: PubMed 39788575de 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 Mar;38(1):40-51. doi: 10.22514/jofph.2024.005. Epub 2024 Mar 12.
- Background: PubMed 39679114Ilhanli M, Ilhanli I, Aksakalli 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 Jul 26;70(3):319-326. doi: 10.5606/tftrd.2024.13517. eCollection 2024 Sep.
- BackgroundO. W. Conservative Management of Temporomandibular Joint Dysfunction: A Case Report. Journal of Health Directories. 2024;1(1):16-23
- Background: PubMed 40447683Yu 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 May 30;15(1):19049. doi: 10.1038/s41598-025-03846-3.
- 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.
Saba Rafique, MS.OMPT principal investigator
Riphah International 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 Stomatognathic Alignment Exercise Program and Standard Physical therapy treatment in people with Craniomandibular Dysfunction, run by Riphah International University at 1 site in Pakistan.
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 5 inclusion and 7 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 Feb 2026. 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 Pakistan. 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?
Numeric Pain Rating Scale (time frame: From enrollment until the end of treatment at the fourth week.). The study lists 2 primary outcomes in all. 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 NCT07403357, which also lists 10 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 Feb 2026.