Forward Head PostureFHPNCT05170776
Efficacy of Adding Pilates to Postural Correction Exercise on Nerve Root Function and Electromyography Activity in Symptomatic Forward Head Posture: Randomized Controlled Trial
A study testing Pilates and postural correction exercise, Pilates exercises and postural correction exercises in people with Forward Head Posture, run by Cairo University at 1 site in Egypt.
Trial summary
to investigate the Efficacy of adding Pilates to postural correction exercise on nerve root function and electromyography activity in symptomatic forward head posture: Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Forward Head Posture
- What is being tested?
- Pilates and postural correction exercise, Pilates exercises and postural correction exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jun 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages from 20-45 years old with symptomatic forward head posture will be included in this study
- Participants have FHP if CVA ≤ 50 Non- athletes
- Normal body mass index (BMI) (18- 24.9). (BMI = body mass in kg divided by subject height in meters).
Who cannot join
- any spinal problems
- Temporomandibular disease
- Participants with experience in pilates and who will not be sedentary were excluded from the study
- Previous surgery in the neck and shoulder
- 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 mylopathy
Trial locations and contacts
1 site in 1 country.
About this study
to investigate the Efficacy of adding Pilates to postural correction exercise on nerve root function and electromyography activity in symptomatic forward head posture: Randomized Controlled Trial
Read the detailed description
Forward head posture (FHP) is nowadays the most common postural problem. In FHP, the head protrudes forward from the sagittal plane and appears to be positioned in front of the body, and this condition is considered the most common postural deformity. The prevalence of anterior head translation in neck pain patients was found to be 37%, out of which 58% were females and 42%were males. FHP is among the most common abnormal postures in upper quarter. 85% of patients with myofascial pain syndrome have FHP. Even more alarming is how frequently these problems are seen in younger populations since it's suggested that problems at a young age may lead to more serious consequences later in life. Pilate's method is a physical fitness system that was developed during the First World War in the early 20th century by Joseph Hubertus Pilates. Direction Control and Range Control exercises are two key types of specific exercises that should be used when specific uncontrolled movements are found. Pilates is a mind-body exercise that focuses on strength, core stability, flexibility, muscle control, posture and breathing. Exercises can be mat-based or involve use of specialized equipment. Six major components of Pilates as: Centering, Concentration, Control, Precision, Flow and Breathing.
pilates exercise and postural correction play a major role in restoring the normal posture in patients with forward head posture so this trial will be conducted to investigate efficacy of adding Pilates to postural correction exercise on nerve root function and electromyography activity in symptomatic forward head posture.
- Conditions
- Forward Head Posture
- Being tested
- Pilates and postural correction exercise, Pilates exercises, postural correction exercises
- Keywords
- forward head psture, Pilates exercise, postural correction exercise, nerve root function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates and postural correction exerciseOther
ten exercises will be performed:
- Hip Twist Level 1
- Double leg stretch Level 1
- Double leg stretch Level 2
- One leg stretch Level 1
- Clam Level 1
- Scissors Level 1
- Arm openings Level 1
- Breast stroke prep Level 1t
- Hip Twist Level 1.
- Breast stroke prep Level 2 as for level 1 postural correction exercise
1-Strengthening deep cervical flexors 2-Stretching cervical extensors 3- Strengthen shoulder retractors 4-Unilateral and bilateral pectoralis stretch
Pilates exercisesOther
ten exercises will be performed:
- Hip Twist Level 1
- Double leg stretch Level 1
- Double leg stretch Level 2
- One leg stretch Level 1
- Clam Level 1
- Scissors Level 1
- Arm openings Level 1
- Breast stroke prep Level 1t
- Hip Twist Level 1.
- Breast stroke prep Level 2 as for level 1
postural correction exercisesOther
postural correction exercise in the form of :
- Strengthening deep cervical flexors through chin tucks,
- Stretching cervical extensors through a chin drop
- Strengthen shoulder retractors
- Unilateral and bilateral pectoralis stretch alternating each two-week period.
| Study group | Role | What they receive |
|---|---|---|
| Pilates and postural correction exercise | Experimental | pilates and postural correction exercise will be received three times a week for 10 weeks Receives: Other: Pilates and postural correction exercise |
| Pilates exercises | Active comparator | pilates exercise will be received three times a week for 10 weeks Receives: Other: Pilates exercises |
| postural correction exercises | Active comparator | postural corrections exercise will be received three times a week for 10 weeks Receives: Other: postural correction exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
nerve root function
nerve root function in the form of somatosensory evoked potential will be measure by electromyograph.
Measured: up to ten weeks
Secondary outcomes (5)
pain intensity
pain intensity will be measure by visual analogue scale.
Measured: up to ten weeks
neck disability
neck disability will be measure by Arabic neck disability index
Measured: up to ten weeks
flexion and extension endurance test
the endurance will be measured by stop watch
Measured: up to ten weeks
muscle amplitude
electromyography will be used to measure the muscle amplitude in the form of root mean square
Measured: up to ten weeks
craniovertebral angle
craniovertebrel angle will be measured by surgimap program
Measured: up to ten weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Forward Head PostureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- this trial has three groups; one experimental and two groups control.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170776
- Sponsor's protocol ID
- p.t.REC/012/003411
- Acronym
- FHP
- Status last verified
- Aug 2022
- First submitted
- 11 Dec 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Pilates to Postural Correction Exercise on Nerve Root Function and Electromyography Activity in Symptomatic Forward Head Posture: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05170776
- Acronym / sponsor ID
- FHP / p.t.REC/012/003411
- Conditions
- Forward Head Posture
- Keywords
- forward head psture, Pilates exercise, postural correction exercise, nerve root function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 28 Dec 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.
to investigate the Efficacy of adding Pilates to postural correction exercise on nerve root function and electromyography activity in symptomatic forward head posture: Randomized Controlled Trial
Detailed description
Forward head posture (FHP) is nowadays the most common postural problem. In FHP, the head protrudes forward from the sagittal plane and appears to be positioned in front of the body, and this condition is considered the most common postural deformity. The prevalence of anterior head translation in neck pain patients was found to be 37%, out of which 58% were females and 42%were males. FHP is among the most common abnormal postures in upper quarter. 85% of patients with myofascial pain syndrome have FHP. Even more alarming is how frequently these problems are seen in younger populations since it's suggested that problems at a young age may lead to more serious consequences later in life. Pilate's method is a physical fitness system that was developed during the First World War in the early 20th century by Joseph Hubertus Pilates. Direction Control and Range Control exercises are two key types of specific exercises that should be used when specific uncontrolled movements are found. Pilates is a mind-body exercise that focuses on strength, core stability, flexibility, muscle control, posture and breathing. Exercises can be mat-based or involve use of specialized equipment. Six major components of Pilates as: Centering, Concentration, Control, Precision, Flow and Breathing.
pilates exercise and postural correction play a major role in restoring the normal posture in patients with forward head posture so this trial will be conducted to investigate efficacy of adding Pilates to postural correction exercise on nerve root function and electromyography activity in symptomatic forward head posture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- this trial has three groups; one experimental and two groups control.
| Arm | Type | Receives |
|---|---|---|
| Pilates and postural correction exercise | Experimental | Other: Pilates and postural correction exercisepilates and postural correction exercise will be received three times a week for 10 weeks |
| Pilates exercises | Active comparator | Other: Pilates exercisespilates exercise will be received three times a week for 10 weeks |
| postural correction exercises | Active comparator | Other: postural correction exercisespostural corrections exercise will be received three times a week for 10 weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Ages from 20-45 years old with symptomatic forward head posture will be included in this study
- Participants have FHP if CVA ≤ 50 Non- athletes
- Normal body mass index (BMI) (18- 24.9). (BMI = body mass in kg divided by subject height in meters).
Key exclusion criteria (7 listed)
- any spinal problems
- Temporomandibular disease
- Participants with experience in pilates and who will not be sedentary were excluded from the study
- Previous surgery in the neck and shoulder
- 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 and postural correction exerciseten exercises will be performed: 1. Hip Twist Level 1 2. Double leg stretch Level 1 3. Double leg stretch Level 2 4. One leg stretch Level 1 5. Clam Level 1 6. Scissors Level 1 7. Arm openings Level 1 8. Breast stroke prep Level 1t 9. Hip Twist Level 1. 10. Breast stroke prep Level 2 as for level 1 postural correction exercise 1-Strengthening deep cervical flexors 2-Stretching cervical extensors 3- Strengthen shoulder retractors 4-Unilateral and bilateral pectoralis stretch | Other | Pilates and postural correction exercise |
| Pilates exercisesten exercises will be performed: 1. Hip Twist Level 1 2. Double leg stretch Level 1 3. Double leg stretch Level 2 4. One leg stretch Level 1 5. Clam Level 1 6. Scissors Level 1 7. Arm openings Level 1 8. Breast stroke prep Level 1t 9. Hip Twist Level 1. 10. Breast stroke prep Level 2 as for level 1 | Other | Pilates exercises |
| postural correction exercisespostural correction exercise in the form of : 1. Strengthening deep cervical flexors through chin tucks, 2. Stretching cervical extensors through a chin drop 3. Strengthen shoulder retractors 4. Unilateral and bilateral pectoralis stretch alternating each two-week period. | Other | postural correction exercises |
Primary outcome
nerve root function
Time frame: up to ten weeks
nerve root function in the form of somatosensory evoked potential will be measure by electromyograph.
5 secondary outcomes
pain intensity
Time frame: up to ten weeks
neck disability
Time frame: up to ten weeks
flexion and extension endurance test
Time frame: up to ten weeks
muscle amplitude
Time frame: up to ten weeks
craniovertebral angle
Time frame: up to ten 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 9 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and postural correction exercise, Pilates exercises and postural correction exercises in people with Forward Head Posture, 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 3 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 9 Aug 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?
nerve root function (time frame: up to ten weeks). 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 9 Aug 2022.