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

Primary Purpose

Pain Management

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
intraarticular radiofrequency + intraarticular methylprednisolone
intraarticular methylprednisolone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Management focused on measuring chronic sacroilitis,radiofrequancy,intraarticular steroids injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut governorate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

group A

group C

Arm Description

receive intraarticular radiofrequency + methylprednisolone (30 mg)

receive intraarticular methylprednisolone (30 mg)

Outcomes

Primary Outcome Measures

pain intensity
Numeric Rating Scale (NRS)

Secondary Outcome Measures

Patient Impression
Patient Global Impression of Change Scale (PGIC)
Pain Disability
Pain Disability Index ( PDI)

Full Information

First Posted
June 2, 2018
Last Updated
January 16, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03564106
Brief Title
Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
Official Title
Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Management
Keywords
chronic sacroilitis,radiofrequancy,intraarticular steroids injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
receive intraarticular radiofrequency + methylprednisolone (30 mg)
Arm Title
group C
Arm Type
Experimental
Arm Description
receive intraarticular methylprednisolone (30 mg)
Intervention Type
Drug
Intervention Name(s)
intraarticular radiofrequency + intraarticular methylprednisolone
Intervention Description
intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)
Intervention Type
Drug
Intervention Name(s)
intraarticular methylprednisolone
Intervention Description
intraarticular methylprednisolone (30 mg)
Primary Outcome Measure Information:
Title
pain intensity
Description
Numeric Rating Scale (NRS)
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Patient Impression
Description
Patient Global Impression of Change Scale (PGIC)
Time Frame
up to 6 months
Title
Pain Disability
Description
Pain Disability Index ( PDI)
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17014598
Citation
Bogduk N. Pulsed radiofrequency. Pain Med. 2006 Sep-Oct;7(5):396-407. doi: 10.1111/j.1526-4637.2006.00210.x. No abstract available.
Results Reference
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PubMed Identifier
18996232
Citation
Borowsky CD, Fagen G. Sources of sacroiliac region pain: insights gained from a study comparing standard intra-articular injection with a technique combining intra- and peri-articular injection. Arch Phys Med Rehabil. 2008 Nov;89(11):2048-56. doi: 10.1016/j.apmr.2008.06.006.
Results Reference
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PubMed Identifier
21055873
Citation
Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.
Results Reference
background
PubMed Identifier
27738191
Citation
Do KH, Ahn SH, Jones R, Jang SH, Son SM, Lee DG, Cho HK, Choi GS, Cho YW. A New Sacroiliac Joint Injection Technique and Its Short-Term Effect on Chronic Sacroiliac Region Pain. Pain Med. 2016 Oct;17(10):1809-1813. doi: 10.1093/pm/pnw003. Epub 2016 Feb 25.
Results Reference
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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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