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

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

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.

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 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: March 1, 2019
• Actual Primary Completion Date: January 1, 2021
• Actual Study Completion Date: January 15, 2021

Arms and Interventions

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

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

• 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

Locations

Egypt

Assiut governorate

Assiut, Egypt

Sponsors and Collaborators

Assiut University

More Information

Publications:

Bogduk N. Pulsed radiofrequency. Pain Med. 2006 Sep-Oct;7(5):396-407. Review.

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.

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.

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.

• Responsible Party: Ghada Mohammed AboelFadl, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03564106
• Other Study ID Numbers: 17200203
• First Posted: June 20, 2018
• Last Update Posted: January 20, 2021
• Last Verified: January 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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