Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction
Primary Purpose
Sacroiliac Joint Somatic Dysfunction, Pain, Disability Physical
Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mulligan mobilization
clamshell exercise
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Joint Somatic Dysfunction
Eligibility Criteria
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
Sites / Locations
- Fatima memorial hospital - Physical therapy clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mulligan mobilization
Mulligan mobilization with clamshell exercise
Arm Description
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.
Outcomes
Primary Outcome Measures
1. NPRS
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"
2. Oswestry Disability index (NDI)
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.
Euro Quality of life (EQ-5D)
Quality of life will be checked by Euro Quality of life (EQ-5D) Health Related Quality of Life Question.
Secondary Outcome Measures
Full Information
NCT ID
NCT05347537
First Posted
April 21, 2022
Last Updated
November 8, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05347537
Brief Title
Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction
Official Title
Effects of Mulligan's Mobilization With and Without Clamshell Exercise on Pain, Disability and Quality of Life in Patients With Sacroiliac Joint Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
September 27, 2022 (Actual)
Study Completion Date
October 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Somatic Dysfunction, Pain, Disability Physical, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mulligan mobilization
Arm Type
Experimental
Arm Description
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.
Arm Title
Mulligan mobilization with clamshell exercise
Arm Type
Active Comparator
Arm Description
Group B will be treated with mulligan's mobilization with movement and clamshell exercises.
Intervention Type
Other
Intervention Name(s)
Mulligan mobilization
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
clamshell exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
1. NPRS
Description
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"
Time Frame
follow up at 6th week
Title
2. Oswestry Disability index (NDI)
Description
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.
Time Frame
follow up at 6th week
Title
Euro Quality of life (EQ-5D)
Description
Quality of life will be checked by Euro Quality of life (EQ-5D) Health Related Quality of Life Question.
Time Frame
follow up at 6th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samrood Akram, Mphill
Organizational Affiliation
Riphah International University, Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatima memorial hospital - Physical therapy clinic
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29484248
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
31992024
Citation
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.
Results Reference
background
PubMed Identifier
31258601
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
Citation
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).
Results Reference
background
PubMed Identifier
33654504
Citation
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.
Results Reference
background
PubMed Identifier
33988941
Citation
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.
Results Reference
background
Citation
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.
Results Reference
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Effects of Mulligan's Mobilization With and Without Clamshell Exercises in Sacroiliac Joint Dysfunction
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