NCT06087432

Brief Summary

The goal of this clinical trial is to compare effects of Rocabado exercises which is conventional physiotherapy treatment alone vs. combine it with proprioceptive neuromuscular facilitation (PNF) in people with temporomandibular dysfunction (TMD) with forward head posture. The main question aims to answer: \- Does adding neck and jaw PNF techniques to the treatment affect the pain and functional status of the jaw compared to Rocabado exercises alone? Participants will be randomized into two groups (Group 1: only Rocabado exercises, Group 2: Rocabado + PNF) and perform 8 weeks long exercises. They will be assessed in the beginning of the study and at the end of the 8th week.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

September 5, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 11, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 20, 2025

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

October 11, 2023

Last Update Submit

February 18, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • Jaw Range of Motion (PMO)

    Painless mouth opening (PMO) is a test in which the individual's maximum capacity to open her/his mouth without pain is measured in cm with a ruler.

    8 weeks

  • Jaw Range of Motion (MMO)

    Maximum mouth opening (MMO) is an outcome measure measured in cm in which the person opens their mouth to the maximum extent they can.

    8 weeks

  • Jaw Range of Motion (MAMO)

    Maximum assisted mouth opening (MAMO) is the maximum amount of opening that a person's mouth is forced to open with the help of the hand.

    8 weeks

  • Pain Intensity

    The person will be asked to mark the degree of pain he/she feels around the jaw on a ruler divided from 0 to 10 at equal intervals. According to VAS, 0 means "no pain" and 10 means "pain as bad as possible."

    8 weeks

Secondary Outcomes (3)

  • Pressure Pain Threshold

    8 weeks

  • Functionality

    8 weeks

  • Mandibular Functionality

    8 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Rocabado's 6 x 6 exercise program has been found to be beneficial in reducing pain and increasing masticatory muscle function, as well as improving forward head posture, correcting limited joint mobility, muscle length limitation, and postural and functional limitations. Rocabado's 6x6 program includes 6 basic components: tongue rest position, TMJ rotation control, cervical spine release, shoulder girdle retraction and rhythmic stabilization technique. Rocabado's 6x6 exercises will be shown to both groups and 6 sets and 6 repetitions will be performed per day for 8 weeks

Other: Rocabado's 6x6 Exercises

Group 2

EXPERIMENTAL

Addition to Rocabado's, Proprioceptive neuromuscular facilitation (PNF) exercises will be applied to the neck and jaw with rhythmic stabilization (RS) and combined isotonic contraction (CIC) techniques. The patient will be placed supine on the treatment bed and asked to relax. The therapist's hands were placed according to PNF principles, depending on the applied technique and diagonality. Maximum resistance was provided to suit the needs of each individual First, the RS protocol will be applied and after a 2-minute rest interval, the exercise will continue with the KIK protocol applications. The expected duration of exercise exercises is 30 minutes. Maximum performance will be requested from the individual in all repetitions and the necessary verbal commands will be given for appropriate movement.

Other: Rocabado's 6x6 ExercisesOther: PNF Exercises

Interventions

Rocabado's 6x6 program includes 6 basic components: tongue rest position, TMJ rotation control, cervical spine release, shoulder girdle retraction and rhythmic stabilization technique.

Group 1Group 2

Proprioceptive neuromuscular facilitation (PNF) exercises will be applied to the neck and jaw with rhythmic stabilization (RS) and combined isotonic contraction (CIC) techniques. The RS protocol consists of alternating isometric contractions for 10 seconds and does not involve movement. The KIK technique involves combined concentric, isometric and eccentric contraction of the agonist muscle without rest, with each contraction lasting 5 seconds. KIK exercises consist of 5-15 repetitions per set, depending on the individual's tolerance. Between sets, a 30-second rest will be included. First, the RS protocol will be applied and after a 2-minute rest interval, the exercise will continue with the KIK protocol applications. The expected duration of exercise exercises is 30 minutes. Maximum performance will be requested from the individual in all repetitions and the necessary verbal commands will be given for appropriate movement.

Group 2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of TMD according to the diagnostic criteria for temporomandibular disorders (RDC/TMD),
  • Presence of trigger points in the relevant muscles,
  • Presence of pain

You may not qualify if:

  • Intra-articular or degenerative joint disorders and subluxation requiring urgent treatment;
  • History of temporomandibular joint (TMJ) or cervical region surgery in the last 3 months;
  • Treatment history from relevant areas;
  • Presence of rheumatic diseases, including TMJ diseases;
  • TMJ instability or fracture;
  • Presence of perception-cognition disorder;
  • Presence of chronic pain such as trigeminal neuralgia
  • Orthopedic, neurological or rheumatological cervical disorders affecting jaw movements
  • History of surgery in the jaw, head and neck area
  • Presence of vertigo that prevents head movements during exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gizem Ergezen

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Temporomandibular Joint DisordersPain

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gizem Ergezen, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 11, 2023

First Posted

October 17, 2023

Study Start

September 5, 2023

Primary Completion

November 5, 2023

Study Completion

December 30, 2024

Last Updated

February 20, 2025

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations