- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07709689
Conventional Sacroiliac Joint Injection Versus Pulsed Radiofrequency in SIJ Pain
Unlocking Sacroiliac Joint Pain: A Comparative Study of Pulsed Radiofrequency and Conventional Technique
Therapeutic options for SIJ pain include intra-articular corticosteroid injections, which provide symptomatic relief but typically require repeated administration due to variable and short-lived efficacy.
More recently, pulsed radiofrequency (PRF) has been investigated for joint pain management through intra-articular electrode placement and stimulation. However, its effectiveness in treating SIJ pain remains insufficiently studied and warrants further exploration.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Walaa Y Elsabeeny, MD
- Phone Number: 01007798466
- Email: walaa.elsabeeny@nci.cu.edu.eg
Study Contact Backup
- Name: Mohamed Magdy, MD
- Phone Number: 01005562356
- Email: Mohammed.magdy@nci.cu.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria
- Sacroiliac Joint (SIJ) Pain
- Diagnostic Block Response: Demonstrated a pain reduction of at least 50% following a diagnostic intra- articular SIJ block.
- Failure of Medical Management
- Chronic Pain Duration: Presence of chronic pain for a minimum duration of 6 months.
- Pain Intensity: A pain intensity score greater than 5 on a 10-point Numeric Rating Scale (NRS), where 0 represents no pain and 10 represents the worst imaginable pain.
- Age: Aged between 18 and 65 years.
- Body Mass Index (BMI): A BMI within the range of 20 kg/m² to 35 kg/m².
Exclusion Criteria:
- Patient refusal.
- Local infection at the puncture site.
- Coagulopathies with platelets count below 50,000 or an INR>1.6.
- Unstable cardiovascular disease and Poor general condition and severe respiratory distress.
- History of psychiatric and cognitive disorders or opioid addiction.
- Patients are allergic to medication used.
- Previous surgery to the affected site.
- Rheumatological disease such as rheumatoid arthtritis or ankylsoing spondyolitis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional injection
Particulate steroid injection in SIJ
|
Sacroiliac joint (SIJ) steroid injection
|
|
Experimental: Pulsed radiofrequency of SIJ
|
PRF of Sacroiliac Joint (SIJ)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric rating score (NRs) reduction
Time Frame: 1 month
|
Numeric rating score (NRs) reduction of pain scores after 1 month
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Chronic Pain
- Sacroiliitis
- Therapeutics
- Physical Therapy Modalities
- Organizations
- Health Care Economics and Organizations
- Rehabilitation
- Electric Stimulation Therapy
- Radiofrequency Therapy
- Congresses as Topic
- Pulsed Radiofrequency Treatment
Other Study ID Numbers
- AP2603-501-165-208
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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