Effectiveness of 5% Dextrose Water Versus Corticosteroid Injection for Pain Management of SJD

NCT06568887 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/741
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The sacroiliac joint (SIJ) is identified as a potential origin of low back pain and referred pain to the lower limb, with a prevalence rate ranging from 7% to 30%. Typically, SIJ pain manifests in the buttock and occasionally extends to the posterior aspect of the ipsilateral thigh, resembling pain originating from lumbar spine sources, such as the zygapophysial joints or intervertebral discs.

Conditions

Sacroiliac Joint Dysfunction

Outcome Measures

Primary Outcomes (2)

• VAS

  The Visual Analog Scale is a subjective measurement tool commonly used in research and clinical settings to assess the intensity or magnitude of various subjective characteristics or attitudes. It typically consists of a 100-mm horizontal or vertical line, with anchor points at each end representing extreme states (e.g., no pain to worst pain imaginable). Participants mark their perceived intensity on the line, and the distance from the starting point is measured to determine the score.

  12 Months

• ODI

  The Oswestry Disability Index is a widely used and well-established questionnaire designed to assess the impact of musculoskeletal conditions on an individual's daily activities and functionality, making it particularly relevant for conditions like piriformis syndrome. The questionnaire consists of ten sections addressing various aspects of daily life, including pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. Participants rate their level of disability in each section on a scale from 0 to 5, with 0 indicating no disability and 5 indicating maximum disability. The scores from each section are then summed and expressed as a percentage, with higher percentages representing greater disability.

  12 months

Study Arms (2)

Dextrose Water

EXPERIMENTAL

Combination Product: Dextrose Water

Corticosteroid Injection

ACTIVE COMPARATOR

Combination Product: Corticosteroid Injection

Interventions

Dextrose Water COMBINATION_PRODUCT

Individuals in this group will receive three injections of 5% dextrose water per week for six weeks period to treat their pain in sacroiliac joint and then their responce will b documented.

Dextrose Water

Corticosteroid Injection COMBINATION_PRODUCT

Individuals in this group will receive three corticosteroid injections per week for a period of six weeks to treat their pain in Sacroiliac joint and then their responce will also be documented.

Corticosteroid Injection

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persons with SIJ pain for at least 3 months

You may not qualify if:

• Pregnancy or breastfeeding
• history of allergy or people contra indicated to our dose
• already received Corticosteroid injection in last 3 months

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: October 30, 2023
• Primary Completion: May 1, 2024
• Study Completion: September 30, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)