- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05347537
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
Status
Completed
Intervention / Treatment
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.
Sponsor
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
- Added MAN, de Freitas DG, Kasawara KT, Martin RL, Fukuda TY. STRENGTHENING THE GLUTEUS MAXIMUS IN SUBJECTS WITH SACROILIAC DYSFUNCTION. Int J Sports Phys Ther. 2018 Feb;13(1):114-120.
- Ramirez C, Sanchez L, Oliveira B. Prevalence of sacroiliac joint dysfunction and sacroiliac pain provocation tests in people with low back pain. Annals of Physical and Rehabilitation Medicine. 2018;61:e152.
- Sarkar M, Goyal M, Samuel AJ. Comparing the Effectiveness of the Muscle Energy Technique and Kinesiotaping in Mechanical Sacroiliac Joint Dysfunction: A Non-blinded, Two-Group, Pretest-Posttest Randomized Clinical Trial Protocol. Asian Spine J. 2021 Feb;15(1):54-63. doi: 10.31616/asj.2019.0300. Epub 2020 Jan 30.
- Bashir MS, Noor R, Hadian MR, Olyaei G. Pattern of changes in latissimus dorsi, gluteus maximus, internal oblique and transverse abdominus muscle thickness among individuals with sacroiliac joint dysfunction. Pak J Med Sci. 2019;35(3):818-823. doi: 10.12669/pjms.35.3.62.
- Jeong S-G, Cynn H-S, Lee J-H, Choi S, Kim D. Effect of modified clamshell exercise on gluteus medius, quadratus lumborum and anterior hip flexor in participants with gluteus medius weakness. Journal of the Korean Society of Physical Medicine. 2019;14(2):9-19.
- Ribeiro S, Heggannavar A, Metgud S. Effect of mulligans mobilization versus manipulation, along with mulligans taping in anterior innominate dysfunction-A randomized clinical trial. Indian Journal of Physical Therapy and Research. 2019;1(1):17.
- Kaur H, Sharma M, Hazari A. Effectiveness of Maitland Mobilization and Mulligan Mobilization in Sacroiliac Joint Dysfunction: A Comparative Study. Critical Reviews™ in Physical and Rehabilitation Medicine. 2019;31(2).
- Sanika V, Prem V, Karvannan H. Comparison of Glutues Maximus Activation to Flexion Bias Exercises Along with MET Technique in Subjects with Anterior Rotated Sacroiliac Joint Dysfunction-a Randomised Controlled Trial. Int J Ther Massage Bodywork. 2021 Mar 1;14(1):30-38. eCollection 2021 Mar.
- Javadov A, Ketenci A, Aksoy C. The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome. Pain Physician. 2021 May;24(3):223-233.
- Saleh HM, Ibrahim AH, Yosef AO, Sedhom MG. EFFECT OF RADIAL EXTRA CORPOREAL SHOCK WAVE THERAPY VERSUS MULLIGAN MOBILIZATION ON SACROILIAC JOINT DYSFUNCTION. Journal of Critical Reviews. 2020;7(19):8055-9.
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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