Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction

November 8, 2022 updated by: Riphah International University

Effects of Mulligan's Mobilization With and Without Clamshell Exercise on Pain, Disability and Quality of Life in Patients With Sacroiliac Joint Dysfunction

Sacroiliac joint dysfunction is the changing of joint structure (ligaments, muscles and cartilage) that cause impairments and movement restrictions. It is one of the primary sources of low back pain among female population and often misdiagnosed. Almost 15-30% patients are suffering from sacroiliac joint dysfunction who presented with the complaint of low back pain. The aim of the study is to determine the effect of mulligan's mobilization with and without clamshell exercise on pain, disability and quality of life in patients with sacroiliac joint dysfunction.

Study Overview

Detailed Description

A Randomized controlled trial will be conducted at Fatima Memorial Hospital Physiotherapy Clinic & Boston Physiotherapy and wellness Clinic through consecutive sampling technique on 32 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A & group B. Group A will be treated with only mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise. Group B will be treated with mulligan's mobilization with movement and clamshell exercises. Outcome measures will be conducted through pain, disability and quality of life questionnaire after 6 weeks. Data will be analyzed during SPSS software version 21. After assessing normality of data by Shapiro Wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • 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 Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Fatima memorial hospital - Physical therapy clinic

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

Ages Eligible for Study

16 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female between the ages of 20 to 50 years with positive Leslett's criteria.
  • Sacroiliac pain of sub-acute level with the duration of 4 weeks

Exclusion Criteria:

  • Spondylosis
  • Lumbar canal stenosis
  • Spondylolisthesis
  • Pervious spinal surgery
  • Congenital postural deformities and
  • Lumbar disc herniation
  • Pelvic bone fractures

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mulligan mobilization
Group A will be treated with only mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise.
Mulligan Mobilization designed to reduce pain and improve the patient's range of motion. Mulligan's mobilization with movement at the frequency of 3 sets with 10 repetitions 3 times/ week without the clamshell exercise.
Active Comparator: Mulligan mobilization with clamshell exercise
Group B will be treated with mulligan's mobilization with movement and clamshell exercises.
As a general exercise, the clamshell can help strengthen your medial glutes, bringing more power and stability to your hips. This group treated with mulligan's mobilization with movement and clamshell exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. NPRS
Time Frame: follow up at 6th week
Patient level of pain was assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain"
follow up at 6th week
2. Oswestry Disability index (NDI)
Time Frame: follow up at 6th week
It comprises 10 items, 7 related with daily activities, 2 related to pain , 1 related to concentration. Each item scores from 0 to 5. Total score is expressed as percentage with higher scores related to greater disability.
follow up at 6th week
Euro Quality of life (EQ-5D)
Time Frame: follow up at 6th week
Quality of life will be checked by Euro Quality of life (EQ-5D) Health Related Quality of Life Question.
follow up at 6th week

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Samrood Akram, Mphill, Riphah International University, Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 27, 2022

Primary Completion (Actual)

September 27, 2022

Study Completion (Actual)

October 15, 2022

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 21, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/Lhr/22/0114 Rahat

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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