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

Pain Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03564106
• Other study ID #: 17200203
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: March 1, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 15, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Management
• Sacroiliitis

Intervention

Drug:
• intraarticular radiofrequency + intraarticular methylprednisolone
intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)
• intraarticular methylprednisolone
intraarticular methylprednisolone (30 mg)

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Bogduk N. Pulsed radiofrequency. Pain Med. 2006 Sep-Oct;7(5):396-407. Review. — View 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. — View 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):481-7. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4. — View 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. Epub 2016 Feb 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity	Numeric Rating Scale (NRS)	up to 6 months
Secondary	Patient Impression	Patient Global Impression of Change Scale (PGIC)	up to 6 months
Secondary	Pain Disability	Pain Disability Index ( PDI)	up to 6 months