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Platelet-rich Plasma in the Sacroiliac Joint

Primary Purpose

Sacroiliac Joint Arthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRP
Steroid Injection
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Arthritis focused on measuring PRP, Platelet-Rich Plasma, Sacroiliac Joint Pain, SIJ Pain, Osteoarthritis

Eligibility Criteria

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

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

Sites / Locations

  • Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Platelet-Rich Plasma Injection

Steroid Injection

Arm Description

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

Steroid injection in the sacroiliac joint

Outcomes

Primary Outcome Measures

Change in Visual Analogue Pain (VAS) Score
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Change in Score on the Oswestry Low Back Pain Disability Questionnaire
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) allows researchers and disability evaluators to measure a patient's permanent functional disability. For each section the total possible score is 5 (0= no pain to 5=worst pain) and there are 10 sections of questions. An aggregate score (percentage) is then calculated, with 0% indicating no disability to 100%, indicating crippled or bed-bound.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2018
Last Updated
September 17, 2019
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT03744234
Brief Title
Platelet-rich Plasma in the Sacroiliac Joint
Official Title
Platelet-rich Plasma in the Sacroiliac Joint
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
September 16, 2019 (Actual)
Study Completion Date
September 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Columbia University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Arthritis
Keywords
PRP, Platelet-Rich Plasma, Sacroiliac Joint Pain, SIJ Pain, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet-Rich Plasma Injection
Arm Type
Experimental
Arm Description
Autologous injection of platelet-rich plasma (PRP) in the sacroiliac joint
Arm Title
Steroid Injection
Arm Type
Active Comparator
Arm Description
Steroid injection in the sacroiliac joint
Intervention Type
Procedure
Intervention Name(s)
PRP
Intervention Description
Autologous platelet-rich plasma
Intervention Type
Procedure
Intervention Name(s)
Steroid Injection
Intervention Description
Steroid injection
Primary Outcome Measure Information:
Title
Change in Visual Analogue Pain (VAS) Score
Description
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
Time Frame
Up to 6 months
Title
Change in Score on the Oswestry Low Back Pain Disability Questionnaire
Description
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) allows researchers and disability evaluators to measure a patient's permanent functional disability. For each section the total possible score is 5 (0= no pain to 5=worst pain) and there are 10 sections of questions. An aggregate score (percentage) is then calculated, with 0% indicating no disability to 100%, indicating crippled or bed-bound.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P. Solberg, DO
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34850180
Citation
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.
Results Reference
derived

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Platelet-rich Plasma in the Sacroiliac Joint

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