Clinical trial NCT03564106: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain Management
Keywords: chronic sacroilitis,radiofrequancy,intraarticular steroids injection
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain intensity
timeFrame: up to 6 months
Secondary outcomes:
measure: Patient Impression
timeFrame: up to 6 months
measure: Pain Disability
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut governorate
Study officials:
References:
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.
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.
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.
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.