NCT07642609

Brief Summary

Cranio-cervico-mandibular (CCM) malalignment is associated with forward head posture (FHP) and tempromandibular joint (TMJ) disorders and affects masticatory muscles. Patients who present with dysfunctions of CCM malalignment can be treated effectively by a physical therapist who has specialized skills and experiences. A temporomandibular joint exercise developed by Rocabado called "Condylar remodeling exercises" considered as a new method for treatment of such cases. Those exercises stimulate mechanoreceptors that converts mechanical energy of physical deformation into action nerve potential yielding proprioceptive information, detecting change and rate of change, as opposed to steady state conditions. This input was analyzed in the central nervous system for joint position and movement influences muscle tone, motor execution programes and kinesthetic awareness around temporomandibular joint protecting joint from damage and helps to restore appropriate balance of synergistic and antagonistic forces. Although condylar remodeling exercises has been used in clinical practice, limited evidence exists to support such a treatment approach. So, the current study will conduct to investigate the effect of Condylar Remodeling Exercises on proprioception of neck and TMJ in CCM malalignment

Trial Health

63
Monitor

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
4mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

June 20, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Temporomandibular joint position sense (TMJPS)

    For the TMJPS measurement, a 6 mm-thick wooden reference stick and 9 wooden test sticks from 4 mm to 8 mmin thickness (increment 0.5 mm) will be used. First, the participants will be asked to sense the position by biting the 6 mm thick reference test stick with their front teeth for 1 minute. Then, they will be asked to randomly bite each of the 9 test sticks and compare each of them with the 6 mm reference test stick. Each of the test sticks will be administered in a random order 5 times (45 tests in total). The participants will be asked how thick they felt compared to the reference stick that they have bitten down on and indicated their answers as "thinner", "thicker" or "equal". During the test, the participant's eyes will be closed, and the answers give about the stick thicknesses will be recorded as true (1 point) or false (0 points).

    24 hours from first and last session

  • Active pain-free mouth opening

    In a supine position, participants will be asked to 'open the mouth as wide as possible without causing pain'. At the end position of pain-free mouth opening, the distance between upper-lower central incisors was measured in millimeters. The mean of three trials was calculated and used for the main analysis. Active pain-free mouth opening will be assessed pre-intervention, 48 h after the last treatment (post-intervention) and at 12-week follow up period.

    24 hours from first and last session

Study Arms (2)

Study group (Condylar remodeling exercises in addition to postural correction Exercise

EXPERIMENTAL

Study group include 20 subjects will receive Condylar remodeling exercises in addition to postural correction Exercise,

Other: Condylar remodeling exercises Included 1)Range of motion phase, 2)Bite phase, 3)Bite return phase, 4)Protrusion, 5)isometric contraction phase Tubing distraction phaseOther: Postural correction exercises Kendall exercises

Control group (postural correction Exercise only)

ACTIVE COMPARATOR

Control group: include 20 subjects will receive postural correction Exercise only

Other: Postural correction exercises Kendall exercises

Interventions

A temporomandibular joint exercise developed by Rocabado called "Condylar remodeling exercises" considered as a new method for treatment of such cases. Those exercises stimulate mechanoreceptors that converts mechanical energy of physical deformation into action nerve potential yielding proprioceptive information, detecting change and rate of change, as opposed to steady state conditions. This input was analysed in the central nervous system for joint position and movement influences muscle tone, motor execution programmes and kinaesthetic awareness around temporomandibular joint protecting joint from damage and helps to restore appropriate balance of synergistic and antagonistic forces. Although condaylar remodling exercises has been used in clinical practice, limited evidence exists to support such a treatment approach

Study group (Condylar remodeling exercises in addition to postural correction Exercise

Kendall exercises were performed as follows: 1. Strengthening the deep cervical flexors: The patient was asked to do a flat-back, chin-down position and hold this position for 2-8 seconds 2. Stretching the cervical extensors: The patient was asked to place one hand on the occipital area and other on the chin in a seated position, then a head-down, flexed neck position to stretch the cervical extensors. 3. Strengthening shoulder retractors: This exercise was done in order to move the shoulder blades towards one another while standing, the patient was instructed to wrap red (medium) Theraband around a stable item and then draw the band back as far as they could with both hands. 4. Stretching of the pectoralis major muscle: The therapist stood behind the patient and held both elbows and performed bilateral pectoralis stretching. To stretch the costal division, the arm should be elevated to approximately 135 degrees. For sternal division, the arm abducted to 90 degrees. For clavicula

Control group (postural correction Exercise only)Study group (Condylar remodeling exercises in addition to postural correction Exercise

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The participants will be excluded if they:
  • The patient's ages from 18 to 40 years
  • having TMD symptoms sustained for at least twelve weeks duration established by expert physician or orthopaedician.
  • having forward head posture with CVA \< 53o.
  • mouth opening \< 25mm.
  • Pain level greater than 20 mm and less than 80 mm on Numeric Rating Scale (NRS).

You may not qualify if:

  • (1) TMJ fracture undergone any surgical procedure for TMJ; (2) Fracture surrounding TMJ; (3) Dislocation or subluxation of TMJ; (4) Systemic joint diseases including rheumatoid arthritis and osteoporosis, congenital conditions orofacial paralysis; (5) recent dental work or TMJ surgery; (6) Hematological cervical disorders which may affect the jaw; (7) Neurological deficits e.g. Bells palsy, Trigeminal neuralgia;(8) Recent infections affecting head and neck (within the last six months) e.g. bone infections, meningitis, encephalitis, malaria, ear infection; (9) Participants who were using any functional appliances e.g.dentures, braces, bite appliances altered or fitted within the previous 12 weeks prior to the commencement of this study; (10) Patients who underwent any physical therapy treatment within the last 2 weeks before the trial; (11) Internal derangement, including disc displacement with or without reduction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr University for Science and Technology

Giza, Egypt

Location

Related Publications (4)

  • Yuzbasioglu U, Kaynak BA, Tas S. Assessment of Cervical Joint Position Sense and Head Posture in Individuals With Myogenic Temporomandibular Dysfunctions and Identifying Related Factors: A Case-Control Study. J Oral Rehabil. 2025 Feb;52(2):160-168. doi: 10.1111/joor.13885. Epub 2024 Oct 20.

  • Dinsdale A, Thomas L, Forbes R, Treleaven J. Is proprioception affected in those with persistent intra-articular temporomandibular disorders? A cross-sectional study exploring joint position sense and force sense of the jaw. Musculoskelet Sci Pract. 2024 Feb;69:102904. doi: 10.1016/j.msksp.2023.102904. Epub 2023 Dec 29.

  • Micoogullari M, Yuksel I, Angin S. Effect of pain on cranio-cervico-mandibular function and postural stability in people with temporomandibular joint disorders. Korean J Pain. 2024 Apr 1;37(2):164-177. doi: 10.3344/kjp.23301.

  • Furto ES, Cleland JA, Whitman JM, Olson KA. Manual physical therapy interventions and exercise for patients with temporomandibular disorders. Cranio. 2006 Oct;24(4):283-91. doi: 10.1179/crn.2006.044.

Central Study Contacts

walaa Mohsen Mohamed, Doctoral degree

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
A randomized, double-blind, controlled trial
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized, double-blind, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

September 20, 2026

Study Completion (Estimated)

October 20, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations