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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03564106
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : January 20, 2021
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, 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.

Condition or disease Intervention/treatment Phase
Pain Management Drug: intraarticular radiofrequency + intraarticular methylprednisolone Drug: intraarticular methylprednisolone Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : January 1, 2021
Actual Study Completion Date : January 15, 2021

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)

Primary Outcome Measures :
  1. pain intensity [ Time Frame: up to 6 months ]
    Numeric Rating Scale (NRS)

Secondary Outcome Measures :
  1. Patient Impression [ Time Frame: up to 6 months ]
    Patient Global Impression of Change Scale (PGIC)

  2. Pain Disability [ Time Frame: up to 6 months ]
    Pain Disability Index ( PDI)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03564106

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Assiut governorate
Assiut, Egypt
Sponsors and Collaborators
Assiut University
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Responsible Party: Ghada Mohammed AboelFadl, Principal Investigator, Assiut University Identifier: NCT03564106    
Other Study ID Numbers: 17200203
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ghada Mohammed AboelFadl, Assiut University:
chronic sacroilitis,radiofrequancy,intraarticular steroids injection
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents