Platelet-rich Plasma in the Sacroiliac Joint

NCT ID: NCT03744234

Last Updated: 2019-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2019-09-16

Brief Summary

This is a double-blinded study where the injecting physicians and the patients will not know which arm they are randomized to. Each participant will be followed up for 6 months following the injection, and will have in office visits at the injection and approximately 2 weeks post injection. They will be called at month 1, 3, and 6 post injection to assess for any adverse events and number of physical therapy hours or changes in medication. At time of injection, 2 weeks post, and 1, 3 and 6 months after they will be asked to answer some questionnaires on pain and function.

Detailed Description

Sacroiliac joint (SIJ) pain is a common and significant source of chronic low back pain. It has been broadly defined as pain located in the area of the SIJ that can be elicited by various pain provocation tests and relieved after infiltration of the joint with local anesthetic.

Essentially, a patients own blood is collected and spun at varying speeds until it separates into 3 layers, one of which is the platelet-rich plasma. Platelet-rich plasma (PRP) injections are commonly used in various conditions including chronic tendinopathy, soft tissue injuries, and ligamentous injuries. More recently, there has been a greater interest in examining the efficacy of PRP as a treatment for musculoskeletal conditions affecting joints, such as osteoarthritis (OA). To the investigators' knowledge, there are currently no reported studies evaluating the efficacy of PRP for SIJ pain. Given the previously discussed application and evidence behind the use of PRP in the knee and hip joints, the investigators propose that PRP can also provide a similar solution for treating SIJ pain.

Conditions

Sacroiliac Joint Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Platelet-Rich Plasma Injection

Autologous injection of platelet-rich plasma (PRP) in the sacroiliac joint

Group Type: EXPERIMENTAL

PRP

Intervention Type: PROCEDURE

Autologous platelet-rich plasma

Steroid Injection

Steroid injection in the sacroiliac joint

Group Type: ACTIVE_COMPARATOR

Steroid Injection

Intervention Type: PROCEDURE

Steroid injection

Interventions

PRP

Autologous platelet-rich plasma

Intervention Type: PROCEDURE

Steroid Injection

Steroid injection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Aged 18 years and older
• Sacroiliac/Lower back pain
• Positive block
• Eligible for steroid injection
• Positive physical manual assessments

Exclusion Criteria

• Steroid allergy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph P. Solberg, DO

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Irving Medical Center

New York, New York, United States

Countries

United States

References

Chen AS, Solberg J, Smith C, Chi M, Lowder R, Christolias G, Singh JR. Intra-Articular Platelet Rich Plasma vs Corticosteroid Injections for Sacroiliac Joint Pain: A Double-Blinded, Randomized Clinical Trial. Pain Med. 2022 Jul 1;23(7):1266-1271. doi: 10.1093/pm/pnab332.

Reference Type: DERIVED

PMID: 34850180 (View on PubMed)

Other Identifiers

AAAQ8843

Identifier Type: -

Identifier Source: org_study_id