Forward Head PostureNCT05895708
Effect of Specific Postural Corrective Exercises on EMG Activity in Patients With Forward Head Posture
A study testing Specific strengthening and stretching exercise and General Exercise in people with Forward Head Posture, run by Beirut Arab University at 1 site in Lebanon.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Forward Head Posture
- What is being tested?
- Specific strengthening and stretching exercise and General Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteLebanon
- Study dates
- 15 Jun 2023to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Lebanon1 site, 1 recruiting
- Recruiting
Physical therapy outpatient clinic
Beirut, 2334
Ahmed ElMelhat, 01112595022, ahmed.elmelhat@cu.edu.eg
About this study
Official title: Effect of Specific Postural Corrective Exercises on EMG Activity of Masticatory and Cervical Muscles in Patients With Forward Head Posture
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.
Read the detailed description
Forward head posture (FHD) is a common habitual faulty posture exists in the surrounding that can alter the resting position of the mandible and may affect the masticatory muscle activity.
The aim of this study is to investigate the effect of postural correction on masticatory and cervical muscle activity and mandibular opening in forward-head posture patients.
Materials and Methods:
- Cranio-vertebral angle measurement CVA
- EMG activity of masseter, temporalis, splenius, upper trapezius and SCM
BAU - Institutional Review Board (Form H-II) | BEIRUT ARAB UNIVERSITY
-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 3 s and repeating 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).
- Conditions
- Forward Head Posture
- Being tested
- Specific strengthening and stretching exercise, General Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific strengthening and stretching exerciseOther
Also called Forward head correction
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: General Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start15 Jun 2023 (estimated)
- Primary completion20 Sep 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Forward Head PostureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beirut Arab University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Abbas, Beirut Arab University
- Investigators
- ahmed el melhat, professor, Study director, Beirut Arab University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895708
- Sponsor's protocol ID
- Forward Head Posture
- Status last verified
- Jun 2023
- First submitted
- 3 Apr 2023
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26476717Zabihhosseinian 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.
PubMed 25843481Lee 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.
PubMed 25931773Quek 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.
PubMed 22959228Lee 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.
PubMed 27512253Kim 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.
PubMed 26311986
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Specific Postural Corrective Exercises on EMG Activity of Masticatory and Cervical Muscles in Patients With Forward Head Posture
- ClinicalTrials.gov ID
- NCT05895708
- Acronym / sponsor ID
- Forward Head Posture
- Conditions
- Forward Head Posture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beirut Arab UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (estimated)
- Primary completion
- 20 Sep 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Forward head posture (FHD) is a common habitual faulty posture exists in the surrounding that can alter the resting position of the mandible and may affect the masticatory muscle activity.
The aim of this study is to investigate the effect of postural correction on masticatory and cervical muscle activity and mandibular opening in forward-head posture patients.
Materials and Methods:
- Cranio-vertebral angle measurement CVA
- EMG activity of masseter, temporalis, splenius, upper trapezius and SCM
BAU - Institutional Review Board (Form H-II) | BEIRUT ARAB UNIVERSITY
-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 3 s and repeating 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specified strengthening and stretching | Experimental | Other: Specific strengthening and stretching exerciseThe 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. |
| General Exercise group | Sham comparator | Other: General ExerciseThe 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific strengthening and stretching exerciseAlso: Forward head correctionThe 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 | Specified strengthening and stretching |
| General ExerciseThe 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 group |
Primary outcome
EMG activity
Time frame: 12 weeks
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 26476717Shaghayegh 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.
- Background: PubMed 25843481Zabihhosseinian 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.
- Background: PubMed 25931773Lee 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.
- Background: PubMed 22959228Quek 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.
- Background: PubMed 27512253Lee 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.
- Background: PubMed 26311986Kim 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.
- Individual participant dataSharing planned: No. 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.
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Forward Head Posture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmed el melhat, professor study director
Beirut Arab University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific strengthening and stretching exercise and General Exercise in people with Forward Head Posture, run by Beirut Arab University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M .elsayed, PhD (00201027943622, ahmed.elmelhat@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EMG activity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05895708, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.