NCT05756010

Brief Summary

This study aims to investigate the effects of forward head correction exercises on EMG of masticatory and cervical muscles in patients with temporomandibular disorder. The study's design will be double-blinded, randomized controlled trial. Patients suffering from TMD will be included in the program. The participants will allocate to one of two groups at random: the experimental group will perform a program consisting of two strengthening exercises (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) and the control group will receive only neck flexion exercise.. This exercise program will be repeated 4 times per week for 10 weeks, and each session lasted for 30 minutes. The muscle activity EMG of masseter, temporalis, splenius, upper trapezius, and SCM will be measured pre and post-assessment using a biopic data acquisition system.

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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

June 7, 2023

Completed
24 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

24 days

First QC Date

February 23, 2023

Last Update Submit

June 6, 2023

Conditions

Keywords

TMJ painEMG activitycervical pain

Outcome Measures

Primary Outcomes (1)

  • EMG activity

    Electrodes will placed on the muscle belly parallel to the direction of muscle fibers. The distance between the two electrodes was 2 cm. The subjects will instructed to complete maximum voluntary contraction (MVC) of clenching the teeth for a period of 3 s and repeated twice. The average of the two trials of MVC will used for further analysis. target muscles include masseter , temporalis, splenius, upper trapezius and sternocleidomastoid muscles.

    10 weeks

Secondary Outcomes (2)

  • Measurement of TMJ range of motion.

    10 weeks

  • Fonseca's questionnaire

    10 weeks

Study Arms (2)

interventional group

EXPERIMENTAL

The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises based on Harman and Mostafa et al's approach.

Device: EMG

conrol group

SHAM COMPARATOR

General exercises

Device: EMG

Interventions

EMGDEVICE

The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises

Also known as: Forward head correction
conrol groupinterventional group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women/aged between 18-40/ patients suffer from TMJ disorder/ no other treatment such as medications, physical therapy, and joint injections in the past 2 weeks

You may not qualify if:

  • Previous history of TMG subluxation or dislocation that may interfere with the opening of the mouth/ Neck pain which may affect the head and neck posture/ Head or neck trauma/.Class II or III malocclusion/ posture disorder caused by abnormal curvature of the spine; rheumatic disease; hemorrhagic disease, etc.;/ Lateral deviation of the mandible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical therapy outpatient clinic

Beirut, 2334, Lebanon

RECRUITING

Related Publications (9)

  • Kim DH, Kim CJ, Son SM. Neck Pain in Adults with Forward Head Posture: Effects of Craniovertebral Angle and Cervical Range of Motion. Osong Public Health Res Perspect. 2018 Dec;9(6):309-313. doi: 10.24171/j.phrp.2018.9.6.04.

    PMID: 30584494BACKGROUND
  • Ballenberger N, von Piekartz H, Paris-Alemany A, La Touche R, Angulo-Diaz-Parreno S. Influence of different upper cervical positions on electromyography activity of the masticatory muscles. J Manipulative Physiol Ther. 2012 May;35(4):308-18. doi: 10.1016/j.jmpt.2012.04.020.

    PMID: 22632591BACKGROUND
  • Wang MQ, He JJ, Wang K, Svensson P. Influence of changing occlusal support on jaw-closing muscle electromyographic activity in healthy men and women. Acta Odontol Scand. 2009;67(3):187-92. doi: 10.1080/00016350902794800.

    PMID: 19291503BACKGROUND
  • Yao Y, Cai B, Fan S, Yang HX, Zhang YX, Xu LL. The association between forward head posture and masticatory muscle pressure pain thresholds in patients with temporomandibular joint dissorders: a cross-sectional observational study. Clin Oral Investig. 2023 Jan;27(1):353-360. doi: 10.1007/s00784-022-04739-9. Epub 2022 Oct 14.

    PMID: 36241923BACKGROUND
  • Xu L, Zhang L, Lu J, Fan S, Cai B, Dai K. Head and neck posture influences masticatory muscle electromyographic amplitude in healthy subjects and patients with temporomandibular disorder: a preliminary study. Ann Palliat Med. 2021 Mar;10(3):2880-2888. doi: 10.21037/apm-20-1850. Epub 2021 Mar 3.

    PMID: 33691457BACKGROUND
  • Berni KC, Dibai-Filho AV, Pires PF, Rodrigues-Bigaton D. Accuracy of the surface electromyography RMS processing for the diagnosis of myogenous temporomandibular disorder. J Electromyogr Kinesiol. 2015 Aug;25(4):596-602. doi: 10.1016/j.jelekin.2015.05.004. Epub 2015 May 27.

    PMID: 26054969BACKGROUND
  • Tecco S, Tete S, D'Attilio M, Perillo L, Festa F. Surface electromyographic patterns of masticatory, neck, and trunk muscles in temporomandibular joint dysfunction patients undergoing anterior repositioning splint therapy. Eur J Orthod. 2008 Dec;30(6):592-7. doi: 10.1093/ejo/cjn052. Epub 2008 Nov 5.

    PMID: 18990679BACKGROUND
  • Chaves TC, Dos Santos Aguiar A, Felicio LR, Greghi SM, Hallak Regalo SC, Bevilaqua-Grossi D. Electromyographic ratio of masseter and anterior temporalis muscles in children with and without temporomandibular disorders. Int J Pediatr Otorhinolaryngol. 2017 Jun;97:35-41. doi: 10.1016/j.ijporl.2017.03.022. Epub 2017 Mar 18.

    PMID: 28483248BACKGROUND
  • Cuenca-Martinez F, Herranz-Gomez A, Madronero-Miguel B, Reina-Varona A, La Touche R, Angulo-Diaz-Parreno S, Pardo-Montero J, Del Corral T, Lopez-de-Uralde-Villanueva I. Craniocervical and Cervical Spine Features of Patients with Temporomandibular Disorders: A Systematic Review and Meta-Analysis of Observational Studies. J Clin Med. 2020 Aug 30;9(9):2806. doi: 10.3390/jcm9092806.

    PMID: 32872670BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersNeck Pain

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ahmed ElMelhat, Professor

    Assistant Prof of Physical Therapy

    STUDY CHAIR

Central Study Contacts

lama bassem jarjour, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate prof of physical therapy

Study Record Dates

First Submitted

February 23, 2023

First Posted

March 6, 2023

Study Start

June 7, 2023

Primary Completion

July 1, 2023

Study Completion

August 29, 2023

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Any study records that identify patient will be kept confidential. The records from the participation may be reviewed by people responsible for making sure that research is done properly, including members of the BAU Institutional Review Board. All of these people are required to keep their identities confidential. Otherwise, records that identify patients will be available only to people working on the study. • We will use a code of numbers and alphabets rather than participants' names on data sheets, keeping records in a safe place.

Locations