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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03564106
Recruitment Status : Recruiting
First Posted : June 20, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, Assiut University

Study Description
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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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : July 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis

Arms and Interventions
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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)


Outcome Measures
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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)


Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ClinicalTrials.gov identifier (NCT number): NCT03564106


Contacts
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Contact: ghada aboelfadl, MD 01005802086 ghadafadl77@gmail.com

Locations
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Egypt
Assiut governorate Recruiting
Assiut, Egypt
Contact: Ghada M Aboelfadl, MD    01005802086    ghadafadl77@gmail.com   
Sponsors and Collaborators
Assiut University
More Information
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Publications:

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Responsible Party: Ghada Mohammed AboelFadl, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03564106    
Other Study ID Numbers: 17200203
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
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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Sacroiliitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents