Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial

September 25, 2023 updated by: Hashim Ahmed, Najran University

Synergistic Benefits of Motor Control Exercises and Balance Training in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial

This research aimed to ascertain the combined and individual efficacies of MCE and BT in alleviating SIJD symptoms.

Study Overview

Detailed Description

The study will be based on a four-arm parallel group randomized control design. one hundred and twenty participants with SIJD will be recruited from the Physiotherapy department, at Integral University, India. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into four groups A, B, C, and D. Experimental group A will be receiving the hot pack, Stretching exercise, and MCE intervention, group B will receive the hot pack, Stretching exercise, and BT exercise and Group C will be receiving the hot pack, Stretching exercise, and MCE & BT intervention, control group D will receive the hot pack, Stretching exercise intervention.

Study Type

Interventional

Enrollment (Actual)

120

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

    • Uttar Pardesh
      • Lucknow, Uttar Pardesh, India
        • Integral University Hospital
    • Najran
      • Najrān, Najran, Saudi Arabia, 1988
        • Hashim Ahmed

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age-30-60 Years
  • sacroiliac joint pain (>3 months)
  • Presence of pain exacerbated as a result of bending laterally or backward
  • Positive results on at least 2 of the pain-provocation tests [FABER, Posterior shear and Gaenslen pain provocation tests) and one of the motion palpation tests (ie, Gillet and forward flexion tests)

Exclusion Criteria:

  • past or current history of surgery or major trauma to spine, pelvis, lower limb, chest or abdomen in the past 12 months
  • lower extremity musculoskeletal disorders; known localized spinal pathology
  • known congenital anomalies of hip, pelvis or spine that limits mobility
  • known systematic arthropathy, neuropathy or metabolic disorder
  • Presence of other causes of LBP such as lumbar discopathy and spinal stenosis discovered via clinical examination and MRI scanning
  • pregnancy

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
MCE Group
Motor control exercises focusing on the activation and control of deep spinal muscles
Participants received hot pack and stretching exercise
Experimental: Group B
BT Group
Participants received hot pack and stretching exercise
Balance training exercises on to enhance proprioception and stability
Experimental: Group C
Combined MCE & BT Group
Motor control exercises focusing on the activation and control of deep spinal muscles
Participants received hot pack and stretching exercise
Balance training exercises on to enhance proprioception and stability
Other: Group D
Control Group
Participants received hot pack and stretching exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 6 Weeks
The pain intensity was assessed Using a numeric pain rating scale (NPRS), It's a 11 point scale, where zero indicates no pain and 10 indicates severe pain
6 Weeks
Functional disability
Time Frame: 6 Weeks
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
6 Weeks
self-reported measure of health
Time Frame: 6 Weeks
It comprises 36 questions that cover eight domains of health
6 Weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Hashim Ahmed, PhD, Najran University

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)

November 1, 2022

Primary Completion (Actual)

August 31, 2023

Study Completion (Actual)

September 20, 2023

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

October 2, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IE/IIMS&R/2022/87

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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