- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06062459
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
Status
Completed
Conditions
Intervention / Treatment
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
-
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Uttar Pardesh
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Lucknow, Uttar Pardesh, India
- Integral University Hospital
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-
-
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Najran
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Najrān, Najran, Saudi Arabia, 1988
- Hashim Ahmed
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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.
Sponsor
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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