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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06228690
Other study ID # S22C08G30024
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2023
Est. completion date December 28, 2023

Study information

Verified date January 2024
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date December 28, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gold Fish exercises
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 training
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 treatment
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.

Locations

Country Name City State
Pakistan Dentovilla Esthetic and Medical Center Islamabad Federal

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary : 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. 4 weeks
Primary Inclinometer It is an instrument that measures the available range of motion at a joint. 4 weeks
Primary 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. 4 weeks
Primary 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. 4 weeks
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