Upper Cross SyndromeNCT06797414
Comparison of Pilate Exercises With and Without Whole Body Vibration in Patient With Upper Cross Syndrome
A study testing Pilate Exercises, Whole-body vibration and Hot Pack in people with Upper Cross Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Nowadays, bad habits brought about by technology such as overuse of mobile phones, televisions, computers, and tablets, resulted in negative impacts on health. Bending in abnormal positions while using these devices causes various mechanical loads on the neck and upper back area, rounded shoulders from increased… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Upper Cross Syndrome
- What is being tested?
- Pilate Exercises, Whole-body vibration and Hot Pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 4 Feb 2024to 7 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient with rounded shoulder
- Forward head
- Having a moderate level of physical activity
- RSP measurement in supine n>1 inch(12)
- NPRS >3(18)
- NDI > 10(19)
Who cannot join
- Pregnant, having untreated wounds, joint or artificial limb
- Suffering from diseases such as-malignancy, diabetes, epilepsy, acute thrombosis, acute migraine, acute infectious conditions, and tumor having history of neurological diseases like vestibulr disease, stroke, kidney or bladder stones, and finally reporting history of back problems such as herniated disk and deformities like scoliosis. experienced any recent trauma (within three months of the initial consultation)
- Chief complaint of headaches or facial pain , hypertension, osteoporosis, and presence of any structural abnormality in the upper and middle back (e.g., scoliosis or presence of positive Adam's test) .
- Participants on anti-inflammatory or muscle relaxant medications were given a three-day period "wash out" before participating in the study (13).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Punjab Employees Social Security Institution
Lahore, Punjab Province, 54000
Affifa Sher Muhammad, DPT, +92 305 4049540, afifa@gmail.com
About this study
Official title: Comparison of Pilate Exercises With and Without Whole Body Vibration on Posture, Disability and Pain in Patient With Upper Cross Syndrome
Nowadays, bad habits brought about by technology such as overuse of mobile phones, televisions, computers, and tablets, resulted in negative impacts on health. Bending in abnormal positions while using these devices causes various mechanical loads on the neck and upper back area, rounded shoulders from increased thoracic kyphosis etc., and this leads to poor posture that can cause UCS. Because of high prevalence of RSP especially in modern societies , proper treatment of this problem is necessary for prevention of further complications.There are different exercise regimes for RSP such as strengthening of lengthened muscles, scapular stabilizers, stretching of shorten muscles especially pectoral muscles, and soft tissue mobilization but Whole-Body Vibration (WBV) is a new method introduced since the last decade and there is no comparison available in the literature of upper cross syndrome between WBV with Pilate exercises on postural correction
The aim of the study is to compare effects Comparison of pilot exercises with and without whole body vibration on posture , disability and pain in patients with upper cross syndrome A randomized clinical trial will be conducted at PESSI.. Non-probability convenience sampling will be used, and 56 subjects, age 20-40 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria. Both groups will receive hot pack for 15-20 minutes and Pilate exercise perform both group as common treatment. Group A will be treated with pilate exercises and Group B will be treated with pilate exercise with whole body vibration Both groups received two sessions per week for four consecutive weeks by another well trained physical therapist. Session duration for both groups ranged from 55 minutes to 1 hour. 2 sessions per week and total 8 sessions for 4 weeks. The outcome measures will be conducted through NPRS,NDI,RSP WAS MEASURED IN SUPINE POSITION AND THEN PML AND TSD before and after 4 weeks. Data will be analyzed using SPSS software version 26.
- Conditions
- Upper Cross Syndrome
- Being tested
- Pilate Exercises, Whole-body vibration, Hot Pack
- Keywords
- Whole Body Vibration, Rounded Shoulder Posture, Pilates Exercise, Upper Cross Syndrome, Young Adult
- Medical subject headings
- Oculocerebral hypopigmentation syndrome type Preus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilate ExercisesOther
PILATES EXERCISE METHODS:
- The cranium, triceps, back, and shoulder blades against the mat, then breath while maintaining muscle contraction .
- Arm circles (both directions) on the mat, then use strong ribcage breathing to connect into scapula.
- Diamond press: lie prone on a mat, using the lower part of the trapezius and serratusanterior muscles to slide shoulder blades out and down. Move into slight back extension maintaining this position.
- Diamond press: repeat above but add lateral arm movement to back extension .
- Arm slides 90°: lies supine on mat with arms bent at 90° and thumbs on floor. Slide elbows on floor toward waistline while contracting serratus anterior muscle.Repeat on the floor with other fingers. Always maintain proper neck alignment .
- Arm circles on a tiny barrel while lying on back with the head and neck supported by the barrel. Opened chest, then link the scapula to the barrel. Hold this position while performing arm circles.
Whole-body vibrationOther
Subjects were placed in a modified push-up position , put their hands in the middle of the platform, shoulder width apart, elbows slightly flexed, and their lower extremities were supported by kneeling on the floor . Vibration protocol included 5 sets of 60 s duration, at 5 mm amplitude and 30 Hz frequency, with a rest period of 60 s between sets . The subjects were reminded kneeling but upright and detached from the platform between sets.
Hot PackDevice
for 10 to 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A: Will be treated with Pilate Exercises. Before applying exercise, hot pack will be applied for 15-20minutes. Receives: Other: Pilate Exercises; Device: Hot Pack |
| Group B | Active comparator | Group B: Will be treated with WBV with Pilate Exercises. Before applying exercise, hot pack will be applied for 15-20minutes. Receives: Other: Pilate Exercises; Other: Whole-body vibration; Device: Hot Pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
Numeric Pain Rating Scale (NRS-11), which is an eleven-point scale in which the end points are the extremes of no pain at all (score of 0) and the worst pain the patient has ever experienced (score of 10). NPRS-11 pain severity score of "4" is frequently given special significance in this regard, suggesting it as a potential threshold value for pain severity in clinical practice(20).
scale has high reliability (0.95-0.96)(21).
Measured: baseline, after 4 weeks
NDI for neck disability (Urdu version)
In 1991, Howard Vernon developed the Neck Disability Index (NDI)(22). The Neck Disability Index (NDI) was the first tool to measure self-reported disability in patients with neck pain. It is used extensively in literature and its psychometric properties have been well established. It has been translated and cross-culturally adapted to many languages. The index has 10 neck-related functional activities scored on a 0-5 scale for each item and a total raw score of 50. The higher the score, the greater the disability(23).
NDI-U is a reliable, valid and responsive questionnaire to measure disability in Urdu- speaking patients with CMNP(24).
Measured: baseline, after 4 weeks
Secondary outcomes (1)
Rounded Shoulder Posture Was Measured In Supine Position And Then Pml And Tsd ( By measuring tape manually)
Supine measurement of RSP:
Iis the distance between the posterior aspect of the lateral acromion process and the exam table in the supine position . An investigator marks the posterior aspect of the lateral acromion process while the subject is in the supine position, with the shoulder in neutral position to avoid measurement variations due to humeral rotation . The investigator then measures the distance from the table to the posterior aspect of the lateral acromion process by using a straight ruler and records the value in inches
PML:
Is the distance from the inferomedial aspect of the coracoid process to the caudal edge of the fourth rib at the sternum . The investigator marks the distance between the inferomedial aspect of the coracoid process and the caudal edge of the fourth rib at the sternum while the subject stands in a relaxed position then records the distanc between the two marked points in inches with a tapeline .
Measured: baseline, after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start4 Feb 2024
- Primary completion7 Feb 2025 (estimated)
- Study completion7 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Cross SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Humera Mubashar, MS, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797414
- Sponsor's protocol ID
- Dr Affifa
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pilate Exercises With and Without Whole Body Vibration on Posture, Disability and Pain in Patient With Upper Cross Syndrome
- ClinicalTrials.gov ID
- NCT06797414
- Acronym / sponsor ID
- Dr Affifa
- Conditions
- Upper Cross Syndrome
- Keywords
- Whole Body Vibration, Rounded Shoulder Posture, Pilates Exercise, Upper Cross Syndrome, Young Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 4 Feb 2024 (actual)
- Primary completion
- 7 Feb 2025 (estimated)
- Study completion
- 7 Feb 2025 (estimated)
- First posted
- 28 Jan 2025 (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.
Nowadays, bad habits brought about by technology such as overuse of mobile phones, televisions, computers, and tablets, resulted in negative impacts on health. Bending in abnormal positions while using these devices causes various mechanical loads on the neck and upper back area, rounded shoulders from increased thoracic kyphosis etc., and this leads to poor posture that can cause UCS. Because of high prevalence of RSP especially in modern societies , proper treatment of this problem is necessary for prevention of further complications.There are different exercise regimes for RSP such as strengthening of lengthened muscles, scapular stabilizers, stretching of shorten muscles especially pectoral muscles, and soft tissue mobilization but Whole-Body Vibration (WBV) is a new method introduced since the last decade and there is no comparison available in the literature of upper cross syndrome between WBV with Pilate exercises on postural correction
The aim of the study is to compare effects Comparison of pilot exercises with and without whole body vibration on posture , disability and pain in patients with upper cross syndrome A randomized clinical trial will be conducted at PESSI.. Non-probability convenience sampling will be used, and 56 subjects, age 20-40 years will be randomly allocated into two groups by lottery method after meeting the inclusion criteria. Both groups will receive hot pack for 15-20 minutes and Pilate exercise perform both group as common treatment. Group A will be treated with pilate exercises and Group B will be treated with pilate exercise with whole body vibration Both groups received two sessions per week for four consecutive weeks by another well trained physical therapist. Session duration for both groups ranged from 55 minutes to 1 hour. 2 sessions per week and total 8 sessions for 4 weeks. The outcome measures will be conducted through NPRS,NDI,RSP WAS MEASURED IN SUPINE POSITION AND THEN PML AND TSD before and after 4 weeks. Data will be analyzed using SPSS software version 26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Pilate Exercises, Device: Hot PackGroup A: Will be treated with Pilate Exercises. Before applying exercise, hot pack will be applied for 15-20minutes. |
| Group B | Active comparator | Other: Pilate Exercises, Other: Whole-body vibration, Device: Hot PackGroup B: Will be treated with WBV with Pilate Exercises. Before applying exercise, hot pack will be applied for 15-20minutes. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient with rounded shoulder
- Forward head
- Having a moderate level of physical activity
- RSP measurement in supine n>1 inch(12)
- NPRS >3(18)
Key exclusion criteria (4 listed)
- Pregnant, having untreated wounds, joint or artificial limb
- Suffering from diseases such as-malignancy, diabetes, epilepsy, acute thrombosis, acute migraine, acute infectious conditions, and tumor having history of neurological diseases like vestibulr disease, stroke, kidney or bladder stones, and finally reporting history of back problems such as herniated disk and deformities like scoliosis. experienced any recent trauma (within three months of the initial consultation)
- Chief complaint of headaches or facial pain , hypertension, osteoporosis, and presence of any structural abnormality in the upper and middle back (e.g., scoliosis or presence of positive Adam's test) .
- Participants on anti-inflammatory or muscle relaxant medications were given a three-day period "wash out" before participating in the study (13).
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 |
|---|---|---|
| Pilate ExercisesPILATES EXERCISE METHODS: 1. The cranium, triceps, back, and shoulder blades against the mat, then breath while maintaining muscle contraction . 2. Arm circles (both directions) on the mat, then use strong ribcage breathing to connect into scapula. 3. Diamond press: lie prone on a mat, using the lower part of the trapezius and serratusanterior muscles to slide shoulder blades out and down. Move into slight back extension maintaining this position. 4. Diamond press: repeat above but add lateral arm movement to back extension . 5. Arm slides 90°: lies supine on mat with arms bent at 90° and thumbs on floor. Slide elbows on floor toward waistline while contracting serratus anterior muscle.Repeat on the floor with other fingers. Always maintain proper neck alignment . 6. Arm circles on a tiny barrel while lying on back with the head and neck supported by the barrel. Opened chest, then link the scapula to the barrel. Hold this position while performing arm circles. | Other | Group A, Group B |
| Whole-body vibrationSubjects were placed in a modified push-up position , put their hands in the middle of the platform, shoulder width apart, elbows slightly flexed, and their lower extremities were supported by kneeling on the floor . Vibration protocol included 5 sets of 60 s duration, at 5 mm amplitude and 30 Hz frequency, with a rest period of 60 s between sets . The subjects were reminded kneeling but upright and detached from the platform between sets. | Other | Group B |
| Hot Packfor 10 to 15 minutes | Device | Group A, Group B |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: baseline, after 4 weeks
Numeric Pain Rating Scale (NRS-11), which is an eleven-point scale in which the end points are the extremes of no pain at all (score of 0) and the worst pain the patient has ever experienced (score of 10). NPRS-11 pain severity score of "4" is frequently given special significance in this regard, suggesting it as a potential threshold value for pain severity in clinical practice(20). scale has high reliability (0.95-0.96)(21).
NDI for neck disability (Urdu version)
Time frame: baseline, after 4 weeks
In 1991, Howard Vernon developed the Neck Disability Index (NDI)(22). The Neck Disability Index (NDI) was the first tool to measure self-reported disability in patients with neck pain. It is used extensively in literature and its psychometric properties have been well established. It has been translated and cross-culturally adapted to many languages. The index has 10 neck-related functional activities scored on a 0-5 scale for each item and a total raw score of 50. The higher the score, the greater the disability(23). NDI-U is a reliable, valid and responsive questionnaire to measure disability in Urdu- speaking patients with CMNP(24).
1 secondary outcome
Rounded Shoulder Posture Was Measured In Supine Position And Then Pml And Tsd ( By measuring tape manually)
Time frame: baseline, after 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Humera Mubashar, MS 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 Pilate Exercises, Whole-body vibration and Hot Pack in people with Upper Cross 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Affifa Sher Muhammad, DPT (0305 4049540, afifa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: baseline, after 4 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 Jan 2025.