NCT03744234

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2019

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2019

Enrollment Period

2.8 years

First QC Date

November 14, 2018

Last Update Submit

September 17, 2019

Conditions

Sacroiliac Joint Arthritis

Keywords

PRPPlatelet-Rich PlasmaSacroiliac Joint PainSIJ PainOsteoarthritis

Outcome Measures

Primary Outcomes (2)

  • 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.

    Up to 6 months

  • 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.

    Up to 6 months

Study Arms (2)

Platelet-Rich Plasma Injection

EXPERIMENTAL

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

Procedure: PRP

Steroid Injection

ACTIVE COMPARATOR

Steroid injection in the sacroiliac joint

Procedure: Steroid Injection

Interventions

PRPPROCEDURE

Autologous platelet-rich plasma

Platelet-Rich Plasma Injection
Steroid InjectionPROCEDURE

Steroid injection

Steroid Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Steroid allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 34850180DERIVED

MeSH Terms

Conditions

SacroiliitisOsteoarthritis

Interventions

Steroids

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Joseph P. Solberg, DO

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 16, 2018

Study Start

December 1, 2016

Primary Completion

September 16, 2019

Study Completion

September 16, 2019

Last Updated

September 18, 2019

Record last verified: 2019-09

Locations

US(1)