Temporo-mandibular DysfunctionNCT05917769
Comparison of Rocabado Approach Versus Postural Correction Exercises on Kinesiophobia and Interincisal Distance in Patients With Temporo-Mandibular Dysfunction
A study testing Rocabdo exercises and Postural correction exercises in people with Temporo-mandibular Dysfunction, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Temporo-mandibular dysfunction can cause pain and tenderness of jaw so posture correction exercises and Rocabado exercises will be performed targeting jaw opening and kinesiophobia. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Temporo-mandibular Dysfunction
- What is being tested?
- Rocabdo exercises and Postural correction exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to 1 Jul 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female of 18 to 45 years with TMD pain for less than six months and pain rating at least moderate in severity
- Must not be receiving any treatment for TMD at the onset of the study (for example, an occlusal splint, prescription medication)
- Pain must have been of masticatory muscle origin
- Pain on jaw movement, headache and referred pain are suggestive of a muscular problems.
Who cannot join
- Patients of Systemic rheumatic disease \& Fibromyalgia
- Dental pathology
- Orofacial pain disorders
- Cervical structural pathology
- Current use of analgesics more than 3 days per week
- Current use of narcotics, hypnotic drugs, sedatives, or muscle relaxants
Trial locations and contacts
1 site in 1 country.
Furqan Hassan, PHD contact
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University Islamabad
Islamabad, Federal, 64000
Rida Nasir, 03215205662
About this study
Temporo-mandibular dysfunction can cause pain and tenderness of jaw so posture correction exercises and Rocabado exercises will be performed targeting jaw opening and kinesiophobia.
Read the detailed description
Temporo-mandibular dysfunction refers to pain in area of Temporo-mandibular joint and masticatory muscles.Temporo-mandibular dysfunction can cause pain or tenderness of jaw and aching pain in and around the ear along with difficulty in chewing.In addition to these symptoms the Temporo-mandibular dysfunction results in impairment of mouth opening. So the posture correction exercises and Rocabado exercises will be used to treat patients which will target jaw opening and kinesiophobia.
- Conditions
- Temporo-mandibular Dysfunction
- Being tested
- Rocabdo exercises, Postural correction exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rocabdo exercisesOther
The exercises created by Dr. Rocabado, will be performed by the patient at home, consist of six different exercises and six repetitions of each exercise, performed six times per day.
It consists of Tongue 'Clucking', Controlled TMJ Rotation on Opening, Mandibular Rhythmic Stabilization, Upper Cervical Distraction, Axial Extension of the Cervical Spine and Shoulder Girdle Retraction. This group will only perform Rocabdo exercises.
Postural correction exercisesOther
- Posture correction exercises will be performed six times a day for six days.
- Patient will be assessed on the first day and then on the last day of the treatment, i.e., on 6th day the patient will be re-assessed after they have performed posture correction exercises.
- Posture correction exercises consist of chin tuck in, chest stretch, wall stretch, on your Back chest stretch and face down arm lifts.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Rocabdo exercises) | Experimental | The exercises created by Dr. Rocabado, will be performed by the patient at home, consist of six different exercises and six repetitions of each exercise, performed six times per day. It consists of Tongue 'Clucking', Controlled TMJ Rotation on Opening, Mandibular Rhythmic Stabilization, Upper Cervical Distraction, Axial Extension of the Cervical Spine and Shoulder Girdle Retraction. Receives: Other: Rocabdo exercises |
| Group B (Postural correction exercises) | Experimental | This group will perform posture correction exercises for six days and six times per day. Posture correction exercises include chest stretch , wall stretch , chin tuck in and face down arm lifts. Receives: Other: Postural correction exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth opening
Maximum pain free opening from incisor to incisor measured vertically by ruler method where the score of less than 25mm indicate TMJ dysfunction
Measured: 6 days
Kinesiophobia
Kinesiophobia is excessive fear of physical movement that results from a feeling of vulnerability to painful injury Or re-injury where the score of 37 on Tampa scale indicate there is kinesiophobia
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start1 Jan 2023
- Primary completion15 Jun 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporo-mandibular DysfunctionStudies of the same condition, open and under way.
- More trials run by Foundation University IslamabadThe sponsor's other registered studies.
- 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
- Group A will receive conventional therapy for pain management and Rocabado exercises. Group B will receive similar basic conventional therapy for pain management and perform posture correction exercises.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917769
- Sponsor's protocol ID
- FUI/CTR/2023/9
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rocabado Approach Versus Postural Correction Exercises on Kinesiophobia and Interincisal Distance in Patients With Temporo-Mandibular Dysfunction
- ClinicalTrials.gov ID
- NCT05917769
- Acronym / sponsor ID
- FUI/CTR/2023/9
- Conditions
- Temporo-mandibular Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 15 Jun 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 26 Jun 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.
Temporo-mandibular dysfunction can cause pain and tenderness of jaw so posture correction exercises and Rocabado exercises will be performed targeting jaw opening and kinesiophobia.
Detailed description
Temporo-mandibular dysfunction refers to pain in area of Temporo-mandibular joint and masticatory muscles.Temporo-mandibular dysfunction can cause pain or tenderness of jaw and aching pain in and around the ear along with difficulty in chewing.In addition to these symptoms the Temporo-mandibular dysfunction results in impairment of mouth opening. So the posture correction exercises and Rocabado exercises will be used to treat patients which will target jaw opening and kinesiophobia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group A will receive conventional therapy for pain management and Rocabado exercises. Group B will receive similar basic conventional therapy for pain management and perform posture correction exercises.
| Arm | Type | Receives |
|---|---|---|
| Group A (Rocabdo exercises) | Experimental | Other: Rocabdo exercisesThe exercises created by Dr. Rocabado, will be performed by the patient at home, consist of six different exercises and six repetitions of each exercise, performed six times per day. It consists of Tongue 'Clucking', Controlled TMJ Rotation on Opening, Mandibular Rhythmic Stabilization, Upper Cervical Distraction, Axial Extension of the Cervical Spine and Shoulder Girdle Retraction. |
| Group B (Postural correction exercises) | Experimental | Other: Postural correction exercisesThis group will perform posture correction exercises for six days and six times per day. Posture correction exercises include chest stretch , wall stretch , chin tuck in and face down arm lifts. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female of 18 to 45 years with TMD pain for less than six months and pain rating at least moderate in severity
- Must not be receiving any treatment for TMD at the onset of the study (for example, an occlusal splint, prescription medication)
- Pain must have been of masticatory muscle origin
- Pain on jaw movement, headache and referred pain are suggestive of a muscular problems.
Key exclusion criteria (6 listed)
- Patients of Systemic rheumatic disease \& Fibromyalgia
- Dental pathology
- Orofacial pain disorders
- Cervical structural pathology
- Current use of analgesics more than 3 days per week
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 |
|---|---|---|
| Rocabdo exercisesThe exercises created by Dr. Rocabado, will be performed by the patient at home, consist of six different exercises and six repetitions of each exercise, performed six times per day. It consists of Tongue 'Clucking', Controlled TMJ Rotation on Opening, Mandibular Rhythmic Stabilization, Upper Cervical Distraction, Axial Extension of the Cervical Spine and Shoulder Girdle Retraction. This group will only perform Rocabdo exercises. | Other | Group A (Rocabdo exercises) |
| Postural correction exercises* Posture correction exercises will be performed six times a day for six days. * Patient will be assessed on the first day and then on the last day of the treatment, i.e., on 6th day the patient will be re-assessed after they have performed posture correction exercises. * Posture correction exercises consist of chin tuck in, chest stretch, wall stretch, on your Back chest stretch and face down arm lifts. | Other | Group B (Postural correction exercises) |
Primary outcome
Mouth opening
Time frame: 6 days
Maximum pain free opening from incisor to incisor measured vertically by ruler method where the score of less than 25mm indicate TMJ dysfunction
Kinesiophobia
Time frame: 6 days
Kinesiophobia is excessive fear of physical movement that results from a feeling of vulnerability to painful injury Or re-injury where the score of 37 on Tampa scale indicate there is kinesiophobia
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
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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.
Furqan Hassan, PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rocabdo exercises and Postural correction exercises in people with Temporo-mandibular Dysfunction, run by Foundation University Islamabad 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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 26 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rida Nasir, MSMSKPT (03215205662, nasirrida487@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth opening (time frame: 6 days). 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?
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 26 Jun 2023.