NCT05347537

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

April 27, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

April 21, 2022

Last Update Submit

November 8, 2022

Conditions

Sacroiliac Joint Somatic DysfunctionPainDisability PhysicalTreatment

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Mulligan mobilization

EXPERIMENTAL

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.

Other: Mulligan mobilization

Mulligan mobilization with clamshell exercise

ACTIVE COMPARATOR

Group B will be treated with mulligan's mobilization with movement and clamshell exercises.

Other: clamshell exercise

Interventions

Mulligan mobilizationOTHER

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.

Mulligan mobilization
clamshell exerciseOTHER

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.

Mulligan mobilization with clamshell exercise

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatima memorial hospital - Physical therapy clinic

Lahore, Punjab Province, 54000, Pakistan

Location

Related 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.

    PMID: 29484248BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 31992024BACKGROUND

  • 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.

    PMID: 31258601BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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).

    BACKGROUND

  • 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.

    PMID: 33654504BACKGROUND

  • 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.

    PMID: 33988941BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Samrood Akram, Mphill

    Riphah International University, Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 26, 2022

Study Start

April 27, 2022

Primary Completion

September 27, 2022

Study Completion

October 15, 2022

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)