Musculoskeletal DiseasesFHPNCT05069181
Pilates Mat Versus Cervical Stabilization Exercises on Myoelectric Activity of Cervical Muscles in Forward Head Posture
A study testing Pilates mat exercises, cervical stabilization exercises and conventional physiotherapy in people with Musculoskeletal Diseases, run by Cairo University at 1 site in Egypt.
Trial summary
see if there is no statistical significant difference between the effects of Pilates mat versus cervical stabilization exercises on myoelectric activity of cervical muscles in young adults with forward head posture. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Pilates mat exercises, cervical stabilization exercises and conventional physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Feb 2022
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects of both genders aged 18-25 years old with forward head posture will be included in this study
- Subjects have forward head posture if craniovertebral angle ≤ 50.
- Subjects complain non- specific neck pain for at least 3 months or at least two episodes of non-specific neck pain during the last three months.
- Normal body mass index
Who cannot join
- Subjects with any spinal problems
- Subjects with experience in Pilates exercises through the last 3 months of the start of intervention will be excluded from the study
- Previous surgery in the neck and shoulder regions
- Current participation in a structured exercises program
- Neurological symptoms of the upper extremities during screening tests (e.g., Spurling test and upper limb tension tests)
- Red flags suggesting of cancer, infection, vascular insufficiency
- Cervical radiculopathy or myelopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilates Mat Versus Cervical Stabilization Exercises on Myoelectric Activity of Cervical Muscles, Craniovertebral Angle, Pain and Function in Young Adults With Forward Head Posture: Randomized Controlled Trial
see if there is no statistical significant difference between the effects of Pilates mat versus cervical stabilization exercises on myoelectric activity of cervical muscles in young adults with forward head posture.
Read the detailed description
Forward head posture (FHP) increases extension of the atlanto-occipital joint and the upper cervical vertebrae as well as flexion of the lower cervical and upper thoracic vertebrae. Furthermore, this posture causes persistent and abnormal contraction of the suboccipital, neck, and shoulder muscles. Additionally, the muscles around the head and shoulders, including the trapezius, sternocleidomastoid, suboccipital, and temporal, are affected by FHP, which further worsens postural deformity. FHP is the most common deviation from ideal head posture and is characterized by the head projecting forward into the sagittal plane such that it is anterior to the trunk. Head in forward posture can add up to thirty pounds of abnormal leverage on the cervical spine, which pull the entire spine out of alignment, in addition, loss of the physiological lordosis could be a possible cause of pain due to muscular imbalance.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Pilates mat exercises, cervical stabilization exercises, conventional physiotherapy
- Keywords
- Forward head posture, Craniovertebral angle, Pilates mat exercises
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates mat exercisesOther
Pilates mat exercises: Each Pilates session will last for one hour and commence with a 10 minute warm up and finish with a 10 min cool down. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centring which is a neutral position of the lumbar spine with activation of the core muscles, ribcage placement, shoulder blade placement and neutral position of the cervical spine with slight upper cervical flexion at the cranio-cervical junction).
Pilates exercise program will consist of warm up exercises, main treatment program (10 level) and cooling down exercises.
cervical stabilization exercisesOther
training of deep cervical flexor muscles with pressure biofeedback unit, 20 min/day, 3 days/week for 12 weeks.
conventional physiotherapyOther
10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program 3 days/week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Pilates mat exercises | Experimental | one hour Pilates exercises with 10 min warm up and 5-10 min cooling down Receives: Other: Pilates mat exercises; Other: conventional physiotherapy |
| cervical stabilization exercises | Experimental | training of deep cervical flexor muscles with pressure biofeedback unit Receives: Other: cervical stabilization exercises; Other: conventional physiotherapy |
| conventional physiotherapy | Active comparator | 10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoelectric activity of cervical muscles
by surface electromyography (EMG)
Measured: up to twelve weeks
Craniocervical angle
by photogrammetric method.
Measured: up to twelve weeks
Secondary outcomes (2)
Pain intensity of neck area
by visual analogue scale 10 cm line with 2 ends, 0 and 10 ends 0 end means no pain 10 end means the worst pain
Measured: up to twelve weeks
function of daily life
by neck disability index
Measured: up to twelve weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start1 Oct 2021
- Primary completion30 Dec 2021
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DiseasesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al Shaymaa Shaaban Abd El Azeim, Cairo University
- Investigators
- Haytham M Elhafez, Professor, Study director, professor of physical therapy- cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05069181
- Sponsor's protocol ID
- P.T.REC/012/003349
- Acronym
- FHP
- Status last verified
- Oct 2022
- First submitted
- 16 Sep 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: we will share the results of the trial 1-craniovertebral angle 2-myoelevtric activity of cervical muscles 3-pain of neck area 4-function and neck disability
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilates Mat Versus Cervical Stabilization Exercises on Myoelectric Activity of Cervical Muscles, Craniovertebral Angle, Pain and Function in Young Adults With Forward Head Posture: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05069181
- Acronym / sponsor ID
- FHP / P.T.REC/012/003349
- Conditions
- Musculoskeletal Diseases
- Keywords
- Forward head posture, Craniovertebral angle, Pilates mat exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 6 Oct 2021 (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.
see if there is no statistical significant difference between the effects of Pilates mat versus cervical stabilization exercises on myoelectric activity of cervical muscles in young adults with forward head posture.
Detailed description
Forward head posture (FHP) increases extension of the atlanto-occipital joint and the upper cervical vertebrae as well as flexion of the lower cervical and upper thoracic vertebrae. Furthermore, this posture causes persistent and abnormal contraction of the suboccipital, neck, and shoulder muscles. Additionally, the muscles around the head and shoulders, including the trapezius, sternocleidomastoid, suboccipital, and temporal, are affected by FHP, which further worsens postural deformity. FHP is the most common deviation from ideal head posture and is characterized by the head projecting forward into the sagittal plane such that it is anterior to the trunk. Head in forward posture can add up to thirty pounds of abnormal leverage on the cervical spine, which pull the entire spine out of alignment, in addition, loss of the physiological lordosis could be a possible cause of pain due to muscular imbalance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilates mat exercises | Experimental | Other: Pilates mat exercises, Other: conventional physiotherapyone hour Pilates exercises with 10 min warm up and 5-10 min cooling down |
| cervical stabilization exercises | Experimental | Other: cervical stabilization exercises, Other: conventional physiotherapytraining of deep cervical flexor muscles with pressure biofeedback unit |
| conventional physiotherapy | Active comparator | Other: conventional physiotherapy10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects of both genders aged 18-25 years old with forward head posture will be included in this study
- Subjects have forward head posture if craniovertebral angle ≤ 50.
- Subjects complain non- specific neck pain for at least 3 months or at least two episodes of non-specific neck pain during the last three months.
- Normal body mass index
Key exclusion criteria (7 listed)
- Subjects with any spinal problems
- Subjects with experience in Pilates exercises through the last 3 months of the start of intervention will be excluded from the study
- Previous surgery in the neck and shoulder regions
- Current participation in a structured exercises program
- Neurological symptoms of the upper extremities during screening tests (e.g., Spurling test and upper limb tension tests)
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 |
|---|---|---|
| Pilates mat exercisesPilates mat exercises: Each Pilates session will last for one hour and commence with a 10 minute warm up and finish with a 10 min cool down. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centring which is a neutral position of the lumbar spine with activation of the core muscles, ribcage placement, shoulder blade placement and neutral position of the cervical spine with slight upper cervical flexion at the cranio-cervical junction). Pilates exercise program will consist of warm up exercises, main treatment program (10 level) and cooling down exercises. | Other | Pilates mat exercises |
| cervical stabilization exercisestraining of deep cervical flexor muscles with pressure biofeedback unit, 20 min/day, 3 days/week for 12 weeks. | Other | cervical stabilization exercises |
| conventional physiotherapy10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program 3 days/week for 12 weeks | Other | Pilates mat exercises, cervical stabilization exercises, conventional physiotherapy |
Primary outcome
Myoelectric activity of cervical muscles
Time frame: up to twelve weeks
by surface electromyography (EMG)
Craniocervical angle
Time frame: up to twelve weeks
by photogrammetric method.
2 secondary outcomes
Pain intensity of neck area
Time frame: up to twelve weeks
function of daily life
Time frame: up to twelve weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: Yes. we will share the results of the trial 1-craniovertebral angle 2-myoelevtric activity of cervical muscles 3-pain of neck area 4-function and neck disability
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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.
Haytham M Elhafez, Professor study director
professor of physical therapy- cairo 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 Pilates mat exercises, cervical stabilization exercises and conventional physiotherapy in people with Musculoskeletal Diseases, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 28 Oct 2022. 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myoelectric activity of cervical muscles (time frame: up to twelve weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2022.