Back to resultsSynergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
Primary Purpose
Sacroiliac Joint Dysfunction
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Motor Control Exercise
Balance Training
Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Joint Dysfunction
Eligibility Criteria
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
Sites / Locations
- Integral University Hospital
- Hashim Ahmed
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Other
Arm Label
Group A
Group B
Group C
Group D
Arm Description
MCE Group
BT Group
Combined MCE & BT Group
Control Group
Outcomes
Primary Outcome Measures
Pain Intensity
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
Functional disability
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
self-reported measure of health
It comprises 36 questions that cover eight domains of health
Secondary Outcome Measures
Full Information
NCT ID
NCT06062459
First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Najran University
1. Study Identification
Unique Protocol Identification Number
NCT06062459
Brief Title
Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
Official Title
Synergistic Benefits of Motor Control Exercises and Balance Training in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
September 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Najran 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
This research aimed to ascertain the combined and individual efficacies of MCE and BT in alleviating SIJD symptoms.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
MCE Group
Arm Title
Group B
Arm Type
Experimental
Arm Description
BT Group
Arm Title
Group C
Arm Type
Experimental
Arm Description
Combined MCE & BT Group
Arm Title
Group D
Arm Type
Other
Arm Description
Control Group
Intervention Type
Other
Intervention Name(s)
Motor Control Exercise
Intervention Description
Motor control exercises focusing on the activation and control of deep spinal muscles
Intervention Type
Other
Intervention Name(s)
Balance Training
Intervention Description
Balance training exercises on to enhance proprioception and stability
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Participants received hot pack and stretching exercise
Primary Outcome Measure Information:
Title
Pain Intensity
Description
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
Time Frame
6 Weeks
Title
Functional disability
Description
Functional limitation was assessed by using Oswestry disability Index questionnaire Each section is scored on a 0-5 scale, 5 representing the greatest disability.
Time Frame
6 Weeks
Title
self-reported measure of health
Description
It comprises 36 questions that cover eight domains of health
Time Frame
6 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim Ahmed, PhD
Organizational Affiliation
Najran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integral University Hospital
City
Lucknow
State/Province
Uttar Pardesh
Country
India
Facility Name
Hashim Ahmed
City
Najrān
State/Province
Najran
ZIP/Postal Code
1988
Country
Saudi Arabia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Synergistic Benefits of MCE and BT in Sacroiliac Joint Dysfunction: A Randomized Controlled Trial
We'll reach out to this number within 24 hrs