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

Effectiveness of 5% Dextrose Water (D/W) Versus Corticosteroid Injection for Pain Management of Sacroiliac Joint Dysfuntion

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sacroiliac Joint Dysfunction
• Intervention / Treatment: Combination product: Dextrose Water; Combination product: Corticosteroid Injection

Detailed Description

For Sacroiliac Joint Dysfunction (SIJD) by examining the comparative effectiveness of two distinct interventions: the innovative 5% Dextrous Water (D/W) solution and the conventional corticosteroid injection. With corticosteroids associated with well-documented side effects and concerns about long-term use, the exploration of 5% D/W is particularly timely and holds promise as a potentially safer alternative.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• persons with SIJ pain for at least 3 months

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Corticosteroid Injection	Combination product: Corticosteroid Injection; 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.
Experimental: Dextrose Water	Combination product: Dextrose Water; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): May 1, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 21, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: MSRSW/Batch-Fall22/741

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No