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

NCT06062459 | Completed

• 1 other identifier: IE/IIMS&R/2022/87
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Sacroiliac Joint Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• self-reported measure of health

  It comprises 36 questions that cover eight domains of health

  6 Weeks

Study Arms (4)

Group A

EXPERIMENTAL

MCE Group

Other: Motor Control Exercise; Other: Control Group

Group B

EXPERIMENTAL

BT Group

Other: Balance Training; Other: Control Group

Group C

EXPERIMENTAL

Combined MCE \& BT Group

Other: Motor Control Exercise; Other: Balance Training; Other: Control Group

Group D

OTHER

Control Group

Other: Control Group

Interventions

Motor Control Exercise OTHER

Motor control exercises focusing on the activation and control of deep spinal muscles

Group A; Group C

Balance Training OTHER

Balance training exercises on to enhance proprioception and stability

Group B; Group C

Control Group OTHER

Participants received hot pack and stretching exercise

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Najran University: lead

Study Sites (2)

Integral University Hospital

Lucknow, Uttar Pardesh, India

Location

Hashim Ahmed

Najrān, Najran Region, 1988, Saudi Arabia

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Hashim Ahmed, PhD

  Najran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: November 1, 2022
• Primary Completion: August 31, 2023
• Study Completion: September 20, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); SA (1)