NCT06732765

Brief Summary

The aim of the study is to compare effects Comparison of Pilate exercises with and without whole body vibration on posture, disability and pain in patients with upper cross syndrome. A randomized contro ltrial will beconductedat PESSI. Non-probability convenience sampling will be used, and 62 subjects, age 20-40 years will be allocated into two groupsby the computer generated software after meeting the inclusion criteria. Both groups will receive hot pack for 15-20 minutes and Pilate exercises perform both groups as common treatment.Group A will be treated with Pilate exercisesandGroupB 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 for 4 weeks will be given. The outcome measures will be conducted through NPRS, NDI, RSP WAS MEASURED IN SUPINE POSITION AND THEN PML AND TSD and J APP/ software before and after 4 weeks. Data will be analyzed using SPSS software version 26.After assessing normality of data by kolmo-grove test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. Data will be collected at baseline and after 4 weeks of follow up.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 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
10 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2024

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

December 13, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

November 25, 2024

Last Update Submit

December 12, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Numeric Pain Rating Scale (NPRS)

    The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults,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)

    6 weeks

  • Universal Goniometer (UG)

    Universal Goniometer (UG) The measurement of joint range of motion (ROM) is an essential procedure used in physical therapy, known as goniometry\[24\].Goniometry, the measurement of joint angles, traditionally performed with a universal goniometer (UG), is a commonly utilized assessment tool in monitoring problems of the musculoskeletal system, as well as the progression of rehabilitation interventions

    6 weeks

  • Modified Oswestry Disability Index (MODI)

    The Oswestry Disability Index (ODI) a patient-completed questionnaire .It provides patients receiving low back pain rehabilitation with a subjective percentage score of their degree of function (disability) in everyday activities. it has become one of the most widely used outcome measures for low back pain

    6 weeks

Study Arms (2)

Pilates exercise program

EXPERIMENTAL

Pilates exercise program Will be treated with WBV with Pilate Exercises. Before applying exercise, hot pack will be applied for 15-20minutes

Other: Pilates exercise program

Traditional physical therapy program

ACTIVE COMPARATOR

traditional physical therapy program in form of stretching, strengthening and postural correction exercises

Other: Traditional physical therapy program

Interventions

Pilates exercise program Will be treated with WBV with Pilate Exercises. Before applying exercise, hot pack will be applied for 15-20minutes

Pilates exercise program

Traditional physical therapy program in form of stretching, strengthening and postural correction exercises

Traditional physical therapy program

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age group between 18 to 45 years
  • Both gender male and female
  • individuals with mechanical lower back pain
  • active trigger point in the quadratus lumborum muscle
  • No previous history of accidents

You may not qualify if:

  • Acute muscular injuries
  • localized or systemic infections
  • lumbar disc herniation
  • spinal abnormalities, any prior history of spinal
  • anticoagulant use and bleeding disorders
  • psychiatric conditions that would have made it difficult to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muhammad Sulman

Sialkot, Punjab Province, 51310, Pakistan

RECRUITING

Study Officials

  • Muhammad Salman, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The Study will be single blind, assessor will be kept blind because patients and clinicians were difficult to mask due to well distinguished treatment protocol.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2024

First Posted

December 13, 2024

Study Start

February 4, 2024

Primary Completion

December 7, 2024

Study Completion

January 15, 2025

Last Updated

December 13, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations