NCT05895708

Brief Summary

This study investigates the effects of specific corrective exercises on EMG of masticatory and cervical muscles in patients with forward head posture. The study's design will be a prospective, double- blinded, randomized controlled trial. The participants will be randomly allocated to one of two groups: the exercise group and the control group. The training groups will perform a program consisting of two strengthening (deep cervical flexors and shoulder retractors) and two stretchings (cervical extensors and pectoral muscles) exercises. This exercise program will be repeated 4 times per week for 10 weeks, and each session lasted 30 minutes. The pre/post assessment of forward head posture will measure by using craniovertebral angle CVA. While the muscle activity EMG of the masseter, temporalis, splenius, upper trapezius, and SCM will measure pre and post-assessment using a biopic data acquisition system. There will be a high significance increase (p-value 0.000) between the pre-and-post CVA between the training groups and the control. And there will be a significant decrease in EMG of the masseter, temporalis, splenius, upper trapezius, and SCM across exercise groups compared to the control. As per the results and analysis, specific postural corrective exercises effectively decrease the EMG of masticatory and cervical muscles in patients with forward head postures.

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

April 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

April 3, 2023

Last Update Submit

June 6, 2023

Conditions

Forward Head Posture

Outcome Measures

Primary Outcomes (1)

  • EMG activity

    Electrodes will be placed on the muscle belly parallel to the direction of muscle fibers. The distance between the two electrodes was 2 cm. The subjects will be 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 be used for further analysis. The subjects will be seated comfortably in a chair (---cm height).

    12 weeks

Other Outcomes (1)

  • craniovertebral angle

    12 weeks

Study Arms (2)

Specified strengthening and stretching

EXPERIMENTAL

The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretching (cervical extensors and pectoral muscles) exercises based on Harman and Mostafa et al's approach. This exercise program will be repeated 4 times per week for 10 weeks, and each session lasted for 30 minutes.

Other: Specific strengthening and stretching exercise

General Exercise group

SHAM COMPARATOR

The program will consist of regular general postural exercises such as postural awareness exercises as well as general strengthening exercises such as range of motion exercises for the upper quadrant. The program will also be repeated 4 times per week for 10 weeks, with each session lasting 30 minutes

Other: General Exercise

Interventions

Specific strengthening and stretching exerciseOTHER

The program consisted of two strengthening (deep cervical flexors and shoulder retractors) and two stretching (cervical extensors and pectoral muscles) exercises based on Harman and Mostafa et al's approach. This exercise program will be repeated 4 times per week for 10 weeks, and each session lasted for 30 minutes.

Also known as: Forward head correction
Specified strengthening and stretching
General ExerciseOTHER

The program will consist of regular general postural exercises such as postural awareness exercises as well as general strengthening exercises such as range of motion exercises for the upper quadrant. The program will also be repeated 4 times per week for 10 weeks, with each session lasting 30 minutes

General Exercise group

Eligibility Criteria

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

You may qualify if:

  • Men and women
  • Age between 18-40
  • Patient with forward head posture, CVA less than 48-50.
  • Patient suffer from temporomandibular joint disorder
  • No other treatment, such as medication, physical therapy, and joint injection, 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 spine; rheumatic disease; haemorrhagic disease, etc.; and
  • Lateral deviation of mandible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical therapy outpatient clinic

Beirut, 2334, Lebanon

RECRUITING

Related Publications (6)

  • Shaghayegh Fard B, Ahmadi A, Maroufi N, Sarrafzadeh J. Evaluation of forward head posture in sitting and standing positions. Eur Spine J. 2016 Nov;25(11):3577-3582. doi: 10.1007/s00586-015-4254-x. Epub 2015 Oct 17.

    PMID: 26476717BACKGROUND

  • Zabihhosseinian M, Holmes MW, Ferguson B, Murphy B. Neck muscle fatigue alters the cervical flexion relaxation ratio in sub-clinical neck pain patients. Clin Biomech (Bristol). 2015 Jun;30(5):397-404. doi: 10.1016/j.clinbiomech.2015.03.020. Epub 2015 Mar 27.

    PMID: 25843481BACKGROUND

  • Lee KJ, Han HY, Cheon SH, Park SH, Yong MS. The effect of forward head posture on muscle activity during neck protraction and retraction. J Phys Ther Sci. 2015 Mar;27(3):977-9. doi: 10.1589/jpts.27.977. Epub 2015 Mar 31.

    PMID: 25931773BACKGROUND

  • Quek J, Pua YH, Clark RA, Bryant AL. Effects of thoracic kyphosis and forward head posture on cervical range of motion in older adults. Man Ther. 2013 Feb;18(1):65-71. doi: 10.1016/j.math.2012.07.005. Epub 2012 Sep 5.

    PMID: 22959228BACKGROUND

  • Lee SM, Lee CH, O'Sullivan D, Jung JH, Park JJ. Clinical effectiveness of a Pilates treatment for forward head posture. J Phys Ther Sci. 2016 Jul;28(7):2009-13. doi: 10.1589/jpts.28.2009. Epub 2016 Jul 29.

    PMID: 27512253BACKGROUND

  • Kim SD. Effects of yoga exercises for headaches: a systematic review of randomized controlled trials. J Phys Ther Sci. 2015 Jul;27(7):2377-80. doi: 10.1589/jpts.27.2377. Epub 2015 Jul 22.

    PMID: 26311986BACKGROUND

Study Officials

  • ahmed el melhat, professor

    Beirut Arab University

    STUDY DIRECTOR

Central Study Contacts

Ahmed M .elsayed, PhD

CONTACT

00201027943622ahmed.elmelhat@cu.edu.eg

Ahmed ElMelhat

CONTACT

0096181437072a.melhat@bau.edu.lb

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 Assistant Dean Faculty of Health Sciences

Study Record Dates

First Submitted

April 3, 2023

First Posted

June 9, 2023

Study Start

June 15, 2023

Primary Completion

September 20, 2023

Study Completion

September 20, 2023

Last Updated

June 9, 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. • The investigators will use a code of numbers and alphabets rather than participants' names on data sheets, keeping records in a safe place.

Locations

LE(1)