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

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ClinicalTrials.gov Identifier: NCT03564106
Recruitment Status : Completed
First Posted : June 20, 2018
Last Update Posted : January 20, 2021
Sponsor:
Information provided by (Responsible Party):
Ghada Mohammed AboelFadl, Assiut University

Tracking Information
First Submitted Date  ICMJE June 2, 2018
First Posted Date  ICMJE June 20, 2018
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE March 1, 2019
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
pain intensity [ Time Frame: up to 6 months ]
Numeric Rating Scale (NRS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
  • Patient Impression [ Time Frame: up to 6 months ]
    Patient Global Impression of Change Scale (PGIC)
  • Pain Disability [ Time Frame: up to 6 months ]
    Pain Disability Index ( PDI)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
Official Title  ICMJE Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Pain Management
Intervention  ICMJE
  • Drug: intraarticular radiofrequency + intraarticular methylprednisolone
    intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)
  • Drug: intraarticular methylprednisolone
    intraarticular methylprednisolone (30 mg)
Study Arms  ICMJE
  • Experimental: group A
    receive intraarticular radiofrequency + methylprednisolone (30 mg)
    Intervention: Drug: intraarticular radiofrequency + intraarticular methylprednisolone
  • Experimental: group C
    receive intraarticular methylprednisolone (30 mg)
    Intervention: Drug: intraarticular methylprednisolone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 16, 2021)
40
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2018)
80
Actual Study Completion Date  ICMJE January 15, 2021
Actual Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03564106
Other Study ID Numbers  ICMJE 17200203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ghada Mohammed AboelFadl, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP