NCT06228690

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

January 18, 2024

Last Update Submit

January 26, 2024

Conditions

Keywords

Temporomandibular joint dysfunction.Gold Fish exercisesCervico-thoracic postural correction training

Outcome Measures

Primary Outcomes (5)

  • 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

  • : 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

  • Inclinometer

    It is an instrument that measures the available range of motion at a joint.

    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.

    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.

    4 weeks

Study Arms (3)

Gold Fish exercises

EXPERIMENTAL

Gold Fish exercises for the flexibility of TMJ that will target the Jaw muscles.

Other: Gold Fish exercises

Cervico-thoracic postural correction training.

EXPERIMENTAL

Cervico-thoracic postural correction training for upper thoracic and neck muscles.

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.

Other: Conventional PT treatment

Interventions

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.

Gold Fish exercises

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.

Cervico-thoracic postural correction training.

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.

Conventional PT treatment

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dentovilla Esthetic and Medical Center

Islamabad, Federal, 46000, Pakistan

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Officials

  • Muhammad Affan Iqbal, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 29, 2024

Study Start

August 3, 2023

Primary Completion

December 1, 2023

Study Completion

December 28, 2023

Last Updated

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations