Temporomandibular JointNCT06228690
Comparison of Gold Fish Exercises and Cervico-thoracic Postural Correction Training in Patients With TMJD
A study testing Gold Fish exercises, Cervico-thoracic postural correction training and Conventional PT treatment in people with Temporomandibular Joint and Temporomandibular Joint Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial is to determine the effect of Gold Fish exercises and cervico-thoracic postural correction training in patients with temporo-mandibular joint dysfunction to improve pain, ROM and maximum mouth opening of jaw. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Temporomandibular Joint, Temporomandibular Joint Dysfunction
- What is being tested?
- Gold Fish exercises, Cervico-thoracic postural correction training and Conventional PT treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 3 Aug 2023to 28 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age group 20-40 Both males and females Forward head posture and temporo-mandibular joint dysfunction for more than 3 months.
- Pain provocation during neck movement, chewing and yawning; more than 5 on the Visual analogue scale.
Who cannot join
- History of cervical spine injury or surgery
- Pain due to underlying condition i.e. neoplasm, vascular disease
- Infection, inflammation
- Erupting 3rd molar/dental origin
- Congenital condition of cervical spine or TMJ
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dentovilla Esthetic and Medical Center
Islamabad, Federal, 46000
About this study
Official title: Comparison of Gold Fish Exercises and Cervico-thoracic Postural Correction Training in Patients With Temporo-mandibular Joint Dysfunction
The aim of this randomized controlled trial is to determine the effect of Gold Fish exercises and cervico-thoracic postural correction training in patients with temporo-mandibular joint dysfunction to improve pain, ROM and maximum mouth opening of jaw.
Read the detailed description
Goldfish Exercise works on the principle of pulsatile motion of Goldfish in water \& thereby imitating the same motion for health benefits. It can be thought of stretching the fibrous bands, reducing TMJ stiffness \& resulting in improvement of mouth opening. It would be beneficial to use this technique on daily basis and as far there are no contraindications of this exercise because it's done within the pain limits \& further progression depends on the mouth opening of the patient.
Posture can affect the three-dimensional movement of the jaw during opening which is seen most clearly in the slumped posture as reduced maximal mouth opening. While mouth opening and head extension are linked, there is variability in the amount of head extension when opening wide and the relationship between head extension and mouth opening is negated when opening in a slumped posture. This has implications for the association of neck dysfunction, posture, and temporo-mandibular joint disorder which should be explored further.
- Being tested
- Gold Fish exercises, Cervico-thoracic postural correction training, Conventional PT treatment
- Keywords
- Temporomandibular joint dysfunction., Gold Fish exercises, Cervico-thoracic postural correction training
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold Fish exercisesOther
Specific exercise for the flexibility of TMJ that will target the Jaw muscles. Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 30-45 minutes Type: Gold Fish exercises for jaw flexibility, pain and maximum mouth opening.
Cervico-thoracic postural correction trainingOther
Cervico-thoracic postural correction training for upper thoracic and neck muscles.
Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 30-45 minutes Type: Muscle energy technique to improve range of motion, pain and maximum mouth opening.
Conventional PT treatmentOther
Conventional PT including Hot Pack for 10mins, Active-Passive neck Stretching Exercise + jaw Isometric Exercises.
- Frequency: hold followed by 5secs rest. 2-3times for 3 times/week for 4 weeks, Intensity: moderate-high intensity (depending on pain tolerance) Time: 30-45 mins for Active-Passive neck Stretching.
- Frequency: 3secs hold, 6 times repetitions for Isometric Exercises. Type: conventional treatment for pain, ROM, MMO.
| Study group | Role | What they receive |
|---|---|---|
| Gold Fish exercises | Experimental | Gold Fish exercises for the flexibility of TMJ that will target the Jaw muscles. Receives: Other: Gold Fish exercises |
| Cervico-thoracic postural correction training. | Experimental | Cervico-thoracic postural correction training for upper thoracic and neck muscles. Receives: Other: Cervico-thoracic postural correction training |
| Conventional PT treatment | Active comparator | Conventional PT including Hot Pack for 10mins, Active-Passive neck Stretching Exercise + jaw Isometric Exercises. Receives: Other: Conventional PT treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vernier calipers
The maximum mouth opening distance is a generally accepted measurement to estimate temporomandibular joint mobility and function. The maximum distance is measured from the incisal edge of the maxillary central incisors to the incisal edge of the mandibular central incisors at the midline. The value is measured in millimeters.
Measured: 4 weeks
: visual analogue scale
VAS is a qualitative pain measurement tool that assigns integer numbers between zero and 10 to different pain levels, where zero means no pain and 10 means excruciating pain. VAS is a reliable scale to measure jaw pain.
Measured: 4 weeks
Inclinometer
It is an instrument that measures the available range of motion at a joint.
Measured: 4 weeks
Neck disability index
It is used for disability in patients related to any musculoskeletal neck condition. Total score is presented in percentage. A higher score tells greater disability while 0 means no disability.
Measured: 4 weeks
Temporomandibular Dysfunction Disability Index (TDI)
The TMJ Disability Index questionnaire focuses on determining prior and post treatment level of function and patient's quality of life and what aspects are affected and to what degree. A total score out of 40 was calculated and converted into percentage.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start3 Aug 2023
- Primary completion1 Dec 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular JointStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Affan Iqbal, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228690
- Sponsor's protocol ID
- S22C08G30024
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gold Fish Exercises and Cervico-thoracic Postural Correction Training in Patients With Temporo-mandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT06228690
- Acronym / sponsor ID
- S22C08G30024
- Keywords
- Temporomandibular joint dysfunction., Gold Fish exercises, Cervico-thoracic postural correction training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 29 Jan 2024 (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 aim of this randomized controlled trial is to determine the effect of Gold Fish exercises and cervico-thoracic postural correction training in patients with temporo-mandibular joint dysfunction to improve pain, ROM and maximum mouth opening of jaw.
Detailed description
Goldfish Exercise works on the principle of pulsatile motion of Goldfish in water \& thereby imitating the same motion for health benefits. It can be thought of stretching the fibrous bands, reducing TMJ stiffness \& resulting in improvement of mouth opening. It would be beneficial to use this technique on daily basis and as far there are no contraindications of this exercise because it's done within the pain limits \& further progression depends on the mouth opening of the patient.
Posture can affect the three-dimensional movement of the jaw during opening which is seen most clearly in the slumped posture as reduced maximal mouth opening. While mouth opening and head extension are linked, there is variability in the amount of head extension when opening wide and the relationship between head extension and mouth opening is negated when opening in a slumped posture. This has implications for the association of neck dysfunction, posture, and temporo-mandibular joint disorder which should be explored further.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gold Fish exercises | Experimental | Other: Gold Fish exercisesGold Fish exercises for the flexibility of TMJ that will target the Jaw muscles. |
| Cervico-thoracic postural correction training. | Experimental | Other: Cervico-thoracic postural correction trainingCervico-thoracic postural correction training for upper thoracic and neck muscles. |
| Conventional PT treatment | Active comparator | Other: Conventional PT treatmentConventional PT including Hot Pack for 10mins, Active-Passive neck Stretching Exercise + jaw Isometric Exercises. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age group 20-40 Both males and females Forward head posture and temporo-mandibular joint dysfunction for more than 3 months.
- Pain provocation during neck movement, chewing and yawning; more than 5 on the Visual analogue scale.
Key exclusion criteria (5 listed)
- History of cervical spine injury or surgery
- Pain due to underlying condition i.e. neoplasm, vascular disease
- Infection, inflammation
- Erupting 3rd molar/dental origin
- Congenital condition of cervical spine or TMJ
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 |
|---|---|---|
| Gold Fish exercisesSpecific exercise for the flexibility of TMJ that will target the Jaw muscles. Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 30-45 minutes Type: Gold Fish exercises for jaw flexibility, pain and maximum mouth opening. | Other | Gold Fish exercises |
| Cervico-thoracic postural correction trainingCervico-thoracic postural correction training for upper thoracic and neck muscles. Frequency: 3 times/week for 4 weeks Intensity: moderate intensity (pain free) Time: 30-45 minutes Type: Muscle energy technique to improve range of motion, pain and maximum mouth opening. | Other | Cervico-thoracic postural correction training. |
| Conventional PT treatmentConventional PT including Hot Pack for 10mins, Active-Passive neck Stretching Exercise + jaw Isometric Exercises. * Frequency: hold followed by 5secs rest. 2-3times for 3 times/week for 4 weeks, Intensity: moderate-high intensity (depending on pain tolerance) Time: 30-45 mins for Active-Passive neck Stretching. * Frequency: 3secs hold, 6 times repetitions for Isometric Exercises. Type: conventional treatment for pain, ROM, MMO. | Other | Conventional PT treatment |
Primary outcome
Vernier calipers
Time frame: 4 weeks
The maximum mouth opening distance is a generally accepted measurement to estimate temporomandibular joint mobility and function. The maximum distance is measured from the incisal edge of the maxillary central incisors to the incisal edge of the mandibular central incisors at the midline. The value is measured in millimeters.
: visual analogue scale
Time frame: 4 weeks
VAS is a qualitative pain measurement tool that assigns integer numbers between zero and 10 to different pain levels, where zero means no pain and 10 means excruciating pain. VAS is a reliable scale to measure jaw pain.
Inclinometer
Time frame: 4 weeks
It is an instrument that measures the available range of motion at a joint.
Neck disability index
Time frame: 4 weeks
It is used for disability in patients related to any musculoskeletal neck condition. Total score is presented in percentage. A higher score tells greater disability while 0 means no disability.
Temporomandibular Dysfunction Disability Index (TDI)
Time frame: 4 weeks
The TMJ Disability Index questionnaire focuses on determining prior and post treatment level of function and patient's quality of life and what aspects are affected and to what degree. A total score out of 40 was calculated and converted into percentage.
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 29 Jan 2024.
- 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.
Muhammad Affan Iqbal, Phd* 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 Gold Fish exercises, Cervico-thoracic postural correction training and Conventional PT treatment in people with Temporomandibular Joint and Temporomandibular Joint 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 2 inclusion and 5 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 29 Jan 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 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?
Vernier calipers (time frame: 4 weeks). The study lists 5 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 29 Jan 2024.