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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05347537
Other study ID # REC/Lhr/22/0114 Rahat
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 27, 2022
Est. completion date October 15, 2022

Study information

Verified date November 2022
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date October 15, 2022
Est. primary completion date September 27, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Mulligan mobilization
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.
clamshell exercise
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.

Locations

Country Name City State
Pakistan Fatima memorial hospital - Physical therapy clinic Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

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. — View 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. — View 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. — View 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.

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).

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.

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.

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.

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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" follow up at 6th week
Primary 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. follow up at 6th week
Primary 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. follow up at 6th week
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