NCT06797414

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1 year

First QC Date

January 22, 2025

Last Update Submit

January 22, 2025

Conditions

Keywords

Whole Body VibrationRounded Shoulder PosturePilates ExerciseUpper Cross SyndromeYoung Adult

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    baseline, after 4 weeks

Secondary Outcomes (1)

  • Rounded Shoulder Posture Was Measured In Supine Position And Then Pml And Tsd ( By measuring tape manually)

    baseline, after 4 weeks

Study Arms (2)

Group A

EXPERIMENTAL

Group A: Will be treated with Pilate Exercises. Before applying exercise, hot pack will be applied for 15-20minutes.

Other: Pilate ExercisesDevice: 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.

Other: Pilate ExercisesOther: Whole-body vibrationDevice: Hot Pack

Interventions

PILATES 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.

Group AGroup B

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.

Group B
Hot PackDEVICE

for 10 to 15 minutes

Group AGroup B

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Punjab Employees Social Security Institution

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Oculocerebral hypopigmentation syndrome type Preus

Study Officials

  • Humera Mubashar, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Affifa Sher Muhammad, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

February 4, 2024

Primary Completion

February 7, 2025

Study Completion

February 7, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations