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

Not Applicable

Completed

• Conditions: Sacroiliac Joint Dysfunction

• Registration Number: NCT06062459
• Lead Sponsor: Najran University

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.

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-08-31
• Status Verified: 2023-09
• Study Completion: 2023-09-20
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	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
Functional disability	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.
self-reported measure of health	6 Weeks	It comprises 36 questions that cover eight domains of health

Trial Locations

Locations (2)

Integral University Hospital; 🇮🇳 Lucknow, Uttar Pardesh, India

Hashim Ahmed; 🇸🇦 Najrān, Najran, Saudi Arabia