Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis

January 16, 2021 updated by: Ghada Mohammed AboelFadl, Assiut University

Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis

The sacroiliac joint is Located between the pelvis and base of the spine, the sacroiliac joints are strong, stable joints that allow for little movement. While these joints do not bend like a knuckle or knee, they are susceptible to degenerative arthritis. Sacroiliac joint pain is one of the most common causes of chronic low back pain, accounting for 10% to 27% of patients with chronic lower back pain. It is known to be caused by abnormal motion in this joint, namely, too much motion or too little motion. Patients with pain experience various degrees of pain in the low back, groin, buttock, or posterior thigh.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pain starts when the Sacroiliac joint gets inflamed. There are several reasons it could happen. It could be hurt when playing sports or if fall down.

Sometimes start hurting when the ligaments that hold the SI joint together are damaged, which may make the joint move abnormally. The pain associated with sacroiliitis most commonly occurs in the buttocks and lower back. It can also affect the legs, groin and even the feet.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Assiut governorate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients must have chronic pain more than 6 months and have failed medical treatment.

Exclusion Criteria:

  • Infection at the site of injection
  • Opioids addiction
  • Coagulopathy or another bleeding diathesis
  • Those who refuse to participate in the study
  • Ankylosing Spondylitis patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group A
receive intraarticular radiofrequency + methylprednisolone (30 mg)
Drug: intraarticular radiofrequency + intraarticular methylprednisolone
intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)
Experimental: group C
receive intraarticular methylprednisolone (30 mg)
Drug: intraarticular methylprednisolone
intraarticular methylprednisolone (30 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: up to 6 months
Numeric Rating Scale (NRS)
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Impression
Time Frame: up to 6 months
Patient Global Impression of Change Scale (PGIC)
up to 6 months
Pain Disability
Time Frame: up to 6 months
Pain Disability Index ( PDI)
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

January 15, 2021

Study Registration Dates

First Submitted

June 2, 2018

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 20, 2018

Study Record Updates

Last Update Posted (Actual)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 16, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17200203

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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