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

Phase 2

Completed

• Conditions: Pain Management
• Interventions: Drug: intraarticular radiofrequency + intraarticular methylprednisolone; Drug: intraarticular methylprednisolone

• Registration Number: NCT03564106
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2018-06-02
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-20
• Study Start: 2019-03-01
• Status Verified: 2021-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-15
• Last Update Submitted: 2021-01-16
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	intraarticular radiofrequency + intraarticular methylprednisolone	receive intraarticular radiofrequency + methylprednisolone (30 mg)
group C	intraarticular methylprednisolone	receive intraarticular methylprednisolone (30 mg)

Primary Outcome Measures

Name	Time	Method
pain intensity	up to 6 months	Numeric Rating Scale (NRS)

Secondary Outcome Measures

Name	Time	Method
Patient Impression	up to 6 months	Patient Global Impression of Change Scale (PGIC)
Pain Disability	up to 6 months	Pain Disability Index ( PDI)

Trial Locations

Locations (1)

Assiut governorate; 🇪🇬 Assiut, Egypt