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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06062459
Other study ID # IE/IIMS&R/2022/87
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date September 20, 2023

Study information

Verified date September 2023
Source Najran University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date September 20, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
Motor Control Exercise
Motor control exercises focusing on the activation and control of deep spinal muscles
Balance Training
Balance training exercises on to enhance proprioception and stability
Control Group
Participants received hot pack and stretching exercise

Locations

Country Name City State
India Integral University Hospital Lucknow Uttar Pardesh
Saudi Arabia Hashim Ahmed Najran Najran

Sponsors (1)

Lead Sponsor Collaborator
Najran University

Countries where clinical trial is conducted

India,  Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 6 Weeks
Primary 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. 6 Weeks
Primary self-reported measure of health It comprises 36 questions that cover eight domains of health 6 Weeks
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