NCT05917769

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 15, 2023

Last Update Submit

June 15, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    6 days

Study Arms (2)

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.

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.

Other: Postural correction exercises

Interventions

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.

Group A (Rocabdo 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.

Group B (Postural correction exercises)

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Foundation University Islamabad

Islamabad, Federal, 64000, Pakistan

RECRUITING

Central Study Contacts

Rida Nasir, MSMSKPT

CONTACT

Furqan Hassan, PHD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2023

First Posted

June 26, 2023

Study Start

January 1, 2023

Primary Completion

June 15, 2023

Study Completion

July 1, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations