Comparative Effects of Eloda With/Without Muscle Energy Technique in Patient With Quadratus Lumborum Syndrome

December 12, 2024 updated by: Riphah International University

Comparative Effects of Eldoa With and Without Muscle Energy Technique on Pain, Range of Motion and Functional Disability in Patient With Quadratus Lumborum Syndrome

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In 2023, conducted the study in Basic Science Department,. Forty participants (females) with UCS were randomly divided into two equal groups: group A (control group) and group B (experimental group). Both groups received two sessions per week for four consecutive weeks. Group A received traditional physical therapy program in form of stretching, strengthening and postural correction exercises while Group B received Pilates exercise program. Primary outcome measures were balance, spinal curvature, Craniovertebral angle (CV), and rounded shoulders. Result was Comparison between pre-and post-treatment .Conclusions was Pilates exercise program proved better than traditional physical therapy program in improving spinal curvature, balance, and function and reducing pain in UCS.Randomized clinical trials (RCTs) were conducted to identify the effectiveness of whole-body vibration (WBV) on strength, power, and muscular endurance in older adults. However, the results of different studies are contradictory.. Conclusion: WBV was effective in increasing lower limb muscle strength. However, no significant results were observed for upper limb strength, lower limb power, and lower and upper limb muscle endurance in older adults. However, more studies are needed to better understand the physiological impacts of WBV in older.A randomized controlled trial was conducted in 2017.The present study aimed to determine the immediate effects of Whole Body vibration (WBV) on Rounded Shoulder Posture (RSP) in healthy women. Thirty female students aged between 18 to 30 years with RSP participated in this study. First, the examiner measured the RSP (in supine position), Pectoralis Minor Length (PML) and Total Scapular Distance (TSD). Then, the subjects performed 5 sets of 1-min WBV (frequency=30 Hz, amplitude=5 mm) with 1 min rest between each set. After intervention, the examiner immediately measured the above mentioned variables. The paired t test was used for data analysis. The analysis showed that WBV significantly decreased the supine measurement of RSP (P<0.001) and TSD (P=0.03) and increased PML (P <0.001). It seems that WBV had immediate effect on postural correction of rounded shoulder posture in the study subjects.While posture is a prevalent issue among young adults due to prolonged sitting and increase use oftechnology, the majorityofresearch studies have primarily focused on other age groups, such as older adults or adolescents and most of work on lower limb , very little study was done in upper limb regarding this issue among young adults.As my study focus posture correction in upper croos syndrom patient . After study some literature found to the best of authors knowledge, although in the past many studies have worked on correction ofposture leading to forward head posture and rounded shoulder in upper cross syndrome.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 Pilate exercises and whole body vibration have been practiced in the treatment of forward head posture and RSP were found effective individually,butthereisalackofComparison of pilot exercises with and without whole body vibration on posture , disability and pain in patients with upper cross syndrome . This RCT aims to evaluate the effect of WBV with exercise and effect of Pilate exercises without WBV will ascertain thatiftwoofthese mayhave differenteffectsonthepain, posture, disability in young adults with upper cross syndrome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Sialkot, Punjab, Pakistan, 51310
        • Recruiting
        • Muhammad Sulman
        • Contact:
        • Principal Investigator:
          • Sufyan Nawaz, MS-NMPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pilates exercise program
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
Pilates exercise program Will be treated with WBV with Pilate Exercises. Before applying exercise, hot pack will be applied for 15-20minutes
Active Comparator: Traditional physical therapy program
traditional physical therapy program in form of stretching, strengthening and postural correction exercises
Other: Traditional physical therapy program
Traditional physical therapy program in form of stretching, strengthening and postural correction exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: 6 weeks
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)
Time Frame: 6 weeks
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)
Time Frame: 6 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Muhammad Salman, PhD, Riphah International University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 7, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 13, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/24/0123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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