Sterno Sympheseal SyndromeNCT06751771
Effects of Comprehensive Correcting Exercise Program and Mckenzie Exercises in Patients With Sternosymphyseal Syndrome
A study testing comprehensive correcting exercise program and McKenzie's method of exercises in people with Sterno Sympheseal Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
A Randomized Clinical Trial will be conducted at Horizon Hospital Physiotherapy Department and Riphah Clinic Lahore through consecutive sampling technique on 36 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Sterno Sympheseal Syndrome
- What is being tested?
- comprehensive correcting exercise program and McKenzie's method of exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2024to 20 Nov 2024
- 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 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18-28
- Both gender male and female
- Participants who have any distance from xiphoid process to pubic symphysis less than 18cm (11 inches)
- Participants with forward head (≥ 44°), round shoulder (≥ 49°) or excessive thoracic kyphosis (≥ 42°) will be measured by photography and flexicurve. Patient agree to sign written consent
Who cannot join
- Subjects younger than 18 years of age, cardiac, respiratory, kidney, circulatory problems, systemic disease, diabetes
- Any trauma or localized infection in neck region
- Pregnancy or suspicion of pregnancy for female subjects.
- A history of fractures, treatment or surgery to the lumbar, thoracic, cervical spine and upper limbs
- Thoracic outlet syndrome.
- Any shoulder pathology causing limitation of movement.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Physiotherapy department of Horizon Hospital and Riphah International clinic Lahore.
Lahore, Punjab Province, 54000
About this study
A Randomized Clinical Trial will be conducted at Horizon Hospital Physiotherapy Department and Riphah Clinic Lahore through consecutive sampling technique on 36 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with comprehensive correcting exercise program (three times a week for 6 weeks) into 3 phases with different intensity and frequency. Group B will receive the McKenzie's method of exercises that include Deep neck flexor (chin tucks), Shoulders shrug McKenzie exercise for neck, Repeated shoulder flexion/Extension, Neck flexion McKenzie exercises. Outcome measure will be conducted through pain and functional disability Index through questionnaire and craniovertebral angle through PhysioMaster/APECS, Thoracic kyphosis through Inclinometer and Range of motion via goniometer.
Read the detailed description
Sternosymphyseal syndrome is a postural syndrome involves excessive lumbar and thoracic kyphosis, a forward drawn head, and hyper-lordosis of the cervicocranial junction. This posture is associated with increased muscular tension and faulty respiration habits. When the slumped posture is assumed for sustained periods of time, increased load is placed on the intervertebral disc. With the sternum approximating the pubic symphysis, diaphragmatic inhibition results in over-activation of scalene and upper trapezius musculature during respiration. This muscle tension is reversible by merely having the patient sit up straight. (Brugger's relief position).
A Randomized Clinical Trial will be conducted at Horizon Hospital Physiotherapy Department and Riphah Clinic Lahore through consecutive sampling technique on 36 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with comprehensive correcting exercise program (three times a week for 6 weeks) into 3 phases with different intensity and frequency. Group B will receive the McKenzie's method of exercises that include Deep neck flexor (chin tucks), Shoulders shrug McKenzie exercise for neck, Repeated shoulder flexion/Extension, Neck flexion McKenzie exercises. Outcome measure will be conducted through pain and functional disability Index through questionnaire and craniovertebral angle through PhysioMaster/APECS, Thoracic kyphosis through Inclinometer and Range of motion via goniometer.
- Conditions
- Sterno Sympheseal Syndrome
- Being tested
- comprehensive correcting exercise program, McKenzie's method of exercises
- Keywords
- Corrective exercises, McKenzie exercises, Thoracic kyphosis, Range of Motion, Functional Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive correcting exercise programOther
Group A will be treated with comprehensive correcting exercise program (three times a week for 6 weeks) into 3 phases with different intensity and frequency
McKenzie's method of exercisesOther
Group B will receive the McKenzie's method of exercises that include Deep neck flexor (chin tucks), Shoulders shrug McKenzie exercise for neck, Repeated shoulder flexion/Extension, Neck flexion McKenzie exercises
| Study group | Role | What they receive |
|---|---|---|
| comprehensive correcting exercise program | Experimental | Group A will be treated with comprehensive correcting exercise program (three times a week for 6 weeks) into 3 phases with different intensity and frequency Receives: Other: comprehensive correcting exercise program |
| McKenzie's method of exercises | Experimental | Group B will receive the McKenzie's method of exercises that include Deep neck flexor (chin tucks), Shoulders shrug McKenzie exercise for neck, Repeated shoulder flexion/Extension, Neck flexion McKenzie exercises Receives: Other: McKenzie's method of exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inclinometer
The thoracic kyphosis will be measured by using an inclinometer. The feet of inclinometer will be placed on the spinal vertebrae which will be palpated first
Measured: 6 WEEK
Numeric pain rate scale (NPRS)
Patient level of pain will be assessed using this 11-point NPRS scale (0-no pain, 10-most intense pain) is the most commonly used version which has good test-retest reliability (r=. 79-. 96) This scale ranges from 0 to 10
Measured: 6th week
Secondary outcomes (1)
Neck Disability Index
This questionnaire will be used to assess disability. It comprises of 10 items; 7 related to daily living activities, 2 related to pain and 1 related to concentration. Each item is scored from 0 to 5. Total score is expressed as a percentage, with higher scores related to greater disability (24). The 10 items, with 6 possible answers in each are scored 0 (no activity limitations) to 5 (major activity limitations) and summed up to yield a total score.
Measured: 6 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start15 Oct 2024
- Primary completion10 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sterno Sympheseal SyndromeStudies 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
- Model description
- COMPARATIVE EFFECTS OF COMPREHENSIVE CORRECTING EXERCISE PROGRAM AND MCKENZIE EXERCISES PROTOCOL ON PAIN, CRANIOVERTEBRAL ANGLE, THORACIC KYPHOSIS ANGLE, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN PATIENTS WITH STERNOSYMPHYSEAL SYNDROME
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabiya Noor, PHD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751771
- Sponsor's protocol ID
- REC/RCR&AHS/24/0109
- Status last verified
- Dec 2024
- First submitted
- 20 Dec 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morris CE, Greenman PE, Bullock MI, Basmajian JV, Kobesova A. Vladimir Janda, MD, DSc: tribute to a master of rehabilitation. Spine (Phila Pa 1976). 2006 Apr 20;31(9):1060-4. doi: 10.1097/01.brs.0000214879.93102.4e.
PubMed 16641785Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.
PubMed 21655457Czaprowski D, Stolinski L, Tyrakowski M, Kozinoga M, Kotwicki T. Non-structural misalignments of body posture in the sagittal plane. Scoliosis Spinal Disord. 2018 Mar 5;13:6. doi: 10.1186/s13013-018-0151-5. eCollection 2018.
PubMed 29516039
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Comprehensive Correcting Exercise Program and Mckenzie Exercises in Patients With Sternosymphyseal Syndrome
- ClinicalTrials.gov ID
- NCT06751771
- Acronym / sponsor ID
- REC/RCR&AHS/24/0109
- Conditions
- Sterno Sympheseal Syndrome
- Keywords
- Corrective exercises, McKenzie exercises, Thoracic kyphosis, Range of Motion, Functional Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 30 Dec 2024 (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.
A Randomized Clinical Trial will be conducted at Horizon Hospital Physiotherapy Department and Riphah Clinic Lahore through consecutive sampling technique on 36 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with comprehensive correcting exercise program (three times a week for 6 weeks) into 3 phases with different intensity and frequency. Group B will receive the McKenzie's method of exercises that include Deep neck flexor (chin tucks), Shoulders shrug McKenzie exercise for neck, Repeated shoulder flexion/Extension, Neck flexion McKenzie exercises. Outcome measure will be conducted through pain and functional disability Index through questionnaire and craniovertebral angle through PhysioMaster/APECS, Thoracic kyphosis through Inclinometer and Range of motion via goniometer.
Detailed description
Sternosymphyseal syndrome is a postural syndrome involves excessive lumbar and thoracic kyphosis, a forward drawn head, and hyper-lordosis of the cervicocranial junction. This posture is associated with increased muscular tension and faulty respiration habits. When the slumped posture is assumed for sustained periods of time, increased load is placed on the intervertebral disc. With the sternum approximating the pubic symphysis, diaphragmatic inhibition results in over-activation of scalene and upper trapezius musculature during respiration. This muscle tension is reversible by merely having the patient sit up straight. (Brugger's relief position).
A Randomized Clinical Trial will be conducted at Horizon Hospital Physiotherapy Department and Riphah Clinic Lahore through consecutive sampling technique on 36 patients which will be allocated using simple random sampling through sealed opaque enveloped into Group A and Group B. Group A will be treated with comprehensive correcting exercise program (three times a week for 6 weeks) into 3 phases with different intensity and frequency. Group B will receive the McKenzie's method of exercises that include Deep neck flexor (chin tucks), Shoulders shrug McKenzie exercise for neck, Repeated shoulder flexion/Extension, Neck flexion McKenzie exercises. Outcome measure will be conducted through pain and functional disability Index through questionnaire and craniovertebral angle through PhysioMaster/APECS, Thoracic kyphosis through Inclinometer and Range of motion via goniometer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- COMPARATIVE EFFECTS OF COMPREHENSIVE CORRECTING EXERCISE PROGRAM AND MCKENZIE EXERCISES PROTOCOL ON PAIN, CRANIOVERTEBRAL ANGLE, THORACIC KYPHOSIS ANGLE, RANGE OF MOTION AND FUNCTIONAL DISABILITY IN PATIENTS WITH STERNOSYMPHYSEAL SYNDROME
| Arm | Type | Receives |
|---|---|---|
| comprehensive correcting exercise program | Experimental | Other: comprehensive correcting exercise programGroup A will be treated with comprehensive correcting exercise program (three times a week for 6 weeks) into 3 phases with different intensity and frequency |
| McKenzie's method of exercises | Experimental | Other: McKenzie's method of exercisesGroup B will receive the McKenzie's method of exercises that include Deep neck flexor (chin tucks), Shoulders shrug McKenzie exercise for neck, Repeated shoulder flexion/Extension, Neck flexion McKenzie exercises |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-28
- Both gender male and female
- Participants who have any distance from xiphoid process to pubic symphysis less than 18cm (11 inches)
- Participants with forward head (≥ 44°), round shoulder (≥ 49°) or excessive thoracic kyphosis (≥ 42°) will be measured by photography and flexicurve. Patient agree to sign written consent
Key exclusion criteria (6 listed)
- Subjects younger than 18 years of age, cardiac, respiratory, kidney, circulatory problems, systemic disease, diabetes
- Any trauma or localized infection in neck region
- Pregnancy or suspicion of pregnancy for female subjects.
- A history of fractures, treatment or surgery to the lumbar, thoracic, cervical spine and upper limbs
- Thoracic outlet syndrome.
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 |
|---|---|---|
| comprehensive correcting exercise programGroup A will be treated with comprehensive correcting exercise program (three times a week for 6 weeks) into 3 phases with different intensity and frequency | Other | comprehensive correcting exercise program |
| McKenzie's method of exercisesGroup B will receive the McKenzie's method of exercises that include Deep neck flexor (chin tucks), Shoulders shrug McKenzie exercise for neck, Repeated shoulder flexion/Extension, Neck flexion McKenzie exercises | Other | McKenzie's method of exercises |
Primary outcome
Inclinometer
Time frame: 6 WEEK
The thoracic kyphosis will be measured by using an inclinometer. The feet of inclinometer will be placed on the spinal vertebrae which will be palpated first
Numeric pain rate scale (NPRS)
Time frame: 6th week
Patient level of pain will be assessed using this 11-point NPRS scale (0-no pain, 10-most intense pain) is the most commonly used version which has good test-retest reliability (r=. 79-. 96) This scale ranges from 0 to 10
1 secondary outcome
Neck Disability Index
Time frame: 6 WEEK
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 30 Dec 2024.
- Background: PubMed 16641785Morris CE, Greenman PE, Bullock MI, Basmajian JV, Kobesova A. Vladimir Janda, MD, DSc: tribute to a master of rehabilitation. Spine (Phila Pa 1976). 2006 Apr 20;31(9):1060-4. doi: 10.1097/01.brs.0000214879.93102.4e.
- Background: PubMed 21655457Page P. Shoulder muscle imbalance and subacromial impingement syndrome in overhead athletes. Int J Sports Phys Ther. 2011 Mar;6(1):51-8.
- Background: PubMed 29516039Czaprowski D, Stolinski L, Tyrakowski M, Kozinoga M, Kotwicki T. Non-structural misalignments of body posture in the sagittal plane. Scoliosis Spinal Disord. 2018 Mar 5;13:6. doi: 10.1186/s13013-018-0151-5. eCollection 2018.
- Individual participant dataSharing planned: No
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.
Rabiya Noor, PHD principal investigator
Riphah International 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 comprehensive correcting exercise program and McKenzie's method of exercises in people with Sterno Sympheseal Syndrome, run by Riphah International University at 1 site in Pakistan.
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 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: finished, as of the sponsor's last update on 30 Dec 2024. 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 Pakistan. 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?
Inclinometer (time frame: 6 WEEK). 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?
On the ClinicalTrials.gov record for NCT06751771, which also lists 3 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 30 Dec 2024.