NCT05709340

Brief Summary

Temporomandibular joint dysfunction (TMJD) is an important health problem that occurs approximately in 22 to 35 percent of adults, different physiotherapy methods are reported as treatment options for management of TMJD. Although that, there is no previous studies about the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture. So, the purpose of the present double-blind, randomized, controlled trial is to investigate the efficacy of PNF exercises in treatment of TMJD in patients with forward head posture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 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

First Submitted

Initial submission to the registry

January 21, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

January 21, 2023

Last Update Submit

April 17, 2023

Conditions

Temporomandibular Joint Disorders

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold

    A pressure algometer will be used for the objective measurement of the PPT. The algometer was pressed on the masseter, temporalis muscles until the patient feel pain. The unit of measurement will be in kg/cm2, and three measurements will be taken every 30 seconds. The average of the three consecutive measurements will be taken as the final value.

    change from base line at 6 weeks.

Secondary Outcomes (3)

  • ROM assessment

    change from base line at 6 weeks.

  • Temporomandibular Disorder Disability Questionnaire

    change from base line at 6 weeks.

  • Numerical Rating Scale (NRS)

    change from baseline at 6 weeks.

Study Arms (2)

study group

EXPERIMENTAL
Other: proprioceptive neuromuscular facilitation exercises

control group

ACTIVE COMPARATOR
Other: traditional physical therapy treatment

Interventions

proprioceptive neuromuscular facilitation exercisesOTHER

PNF exercises will be done for Masseter, Temporalis, Lateral pterygoid and medial pterygoid muscles. Each contraction will be held for 10 seconds, and each stretch (relaxation phase) will be allowed to continue as long as the muscle tension continued to give away.

study group
traditional physical therapy treatmentOTHER

* Ultrasound: Continuous ultrasound at 1MHZ to temporomandibular joint at 1.0-1.25 W/CM2 for 5 min over each affected TMJ and masseter area, with the mouth in a slightly open position. * Forward head posture correction exercises including: chin tuck exercise, Strengthening shoulder retractors, stretching of sternocleidomastoid muscle, and Stretching of pectoralis muscle.

control group

Eligibility Criteria

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

You may qualify if:

  • Patients of both genders of age between 20-40 years
  • having symptoms of TMD for at least six weeks duration established by an expert physician or orthopaedician
  • having forward head posture with CVA \< 53
  • pain over TMJ between 3 to 6 on NPRS
  • mouth opening \< 25mm.

You may not qualify if:

  • Patients will be excluded if they exhibited any of the following criteria:
  • TMJ fracture undergone any surgical procedure for TMJ
  • Fracture surrounding TMJ
  • Dislocation or subluxation of TMJ
  • systemic generalized joint diseases, such as rheumatoid arthritis, and osteoporosis, congenital diseases, or facial paralysis
  • recently any dental treatment is taken or surgery over TMJ
  • hematological cervical disorders which may affect the jaw
  • Neurological deficits e.g. Bells palsy, Trigeminal neuralgia.
  • Recent infections (within the last six months) affecting the head and neck e.g. bone infections, meningitis, encephalitis, malaria, ear infection
  • Participants who were using any functional appliances e.g. dentures, braces, bite appliances which had been adjusted or fitted in the last 12 weeks prior to the commencement of this study
  • DDwR, DDwoR
  • Patients were excluded from the study if they were receiving any other form of treatment for their TMJ dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

marwa S saleh

Giza, Egypt

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistance professor doctor

Study Record Dates

First Submitted

January 21, 2023

First Posted

February 2, 2023

Study Start

January 25, 2023

Primary Completion

March 25, 2023

Study Completion

April 15, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

EG(1)