Low Back PainNCT05121961
Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Versus Steroid/Anesthetic
A study testing Sacroiliac intra-articular injection in people with Low Back Pain and Sacroiliac Joint Synovitis, run by University of Utah at 2 sites in United States.
Trial summary
The purpose of this study is to determine if platelet-rich plasma is superior to steroid/anesthetic for the treatment of sacroiliac joint pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Sacroiliac Joint Synovitis
- What is being tested?
- Sacroiliac intra-articular injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Feb 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 y/o) males and females referred for therapeutic injection to the investigators spine interventional service by a physiatrist or pain anesthesiologist with a clinical diagnosis of SIJ pain confirmed by history
- 50% or greater reduction in pain by a diagnostic anesthetic block using no more than 1.5 cc 2% lidocaine performed under imaging guidance by a pain interventionalist (PM\&R, Pain Anesthesia, or Neuroradiology Spine Intervention).
- Baseline pain must be >/=4 by numeric rating scale (NRS), at least 6 weeks in chronicity, and must not be multi-factorial (related to radiculopathy or axial pain localizing elsewhere) by physical examination or confounding medical history (infection, inflammatory spondyloarthropathy, or osseous metastatic disease).
Who cannot join
- SIJ steroid treatment within the prior 6 months.
- Patients with a history of infection currently on antibiotic therapy
- Usage of systemic immunosuppressants
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah
Salt Lake City, Utah, 84132
Veterans Administration Salt Lake City Health Care System
Salt Lake City, Utah, 84148
About this study
Official title: Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Regenerative Therapy: A Randomized Controlled Trial in Comparison With Steroid/Anesthetic Injection With Advanced MR Analysis
The purpose of this study is to determine if platelet-rich plasma is superior to steroid/anesthetic for the treatment of sacroiliac joint pain.
Read the detailed description
All patients with sacroiliac joint pain diagnosed by a back pain specialist will undergo physical examination maneuvers and a test lidocaine injection of the joint. Patients who meet eligibility requirements will be randomized in a single-blind randomized controlled manner with a 50% chance of receiving platelet-rich plasma versus steroid/anesthetic injection of the sacroiliac joint(s).
- Conditions
- Low Back Pain, Sacroiliac Joint Synovitis
- Being tested
- Sacroiliac intra-articular injection
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacroiliac intra-articular injectionProcedure or surgery
CT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich Plasma | Experimental | Patients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint. Receives: Procedure: Sacroiliac intra-articular injection |
| Steroid/Anesthetic | Active comparator | Patients will receive an intra-articular injection 40 mg Depo-medrol mixed with 2 mL 0.25% bupivicaine in the sacroiliac joint. Receives: Procedure: Sacroiliac intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Validated pain scale rating pain on a scale of 0 through 10. 0 for no pain, and 10 for the highest pain the patient can imagine.
Measured: Change between baseline and 3-months post-intervention
Secondary outcomes (4)
Modified Oswestry Disability Questionnaire
Validated questionnaire used to evaluate function in patients with low back pain. The final score/index ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Measured: Change between baseline and 3-months post-intervention
Short-Form 12 Survey
Validated survey used to evaluate function in patients with low back pain. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Measured: Change between baseline and 3-months post-intervention
Functional testing
2 validated tests for low back pain "get up and go," "5 time sit to stand." Shorter times indicate better physical function, and longer times indicate poorer physical function.
Measured: Change between baseline and 3-months post-intervention
Opiate/pain medication usage questionnaire
Questionnaire on type, dose, and frequency of pain medications being used by the patient. All opiates will be converted to the morphine milligram equivalent scale with lower values indicating lower opiate content and higher values indicating higher opiate content
Measured: Change between baseline and 3-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start22 Feb 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Principal investigator, Miriam Peckham, University of Utah
- Investigators
- Miriam Peckham, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121961
- Sponsor's protocol ID
- RSCH1923
- Status last verified
- Apr 2026
- First submitted
- 20 Oct 2021
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment for Sacroiliac Joint Pain Using Platelet-rich Plasma (PRP) Regenerative Therapy: A Randomized Controlled Trial in Comparison With Steroid/Anesthetic Injection With Advanced MR Analysis
- ClinicalTrials.gov ID
- NCT05121961
- Acronym / sponsor ID
- RSCH1923
- Conditions
- Low Back Pain, Sacroiliac Joint Synovitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- 22 Feb 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if platelet-rich plasma is superior to steroid/anesthetic for the treatment of sacroiliac joint pain.
Detailed description
All patients with sacroiliac joint pain diagnosed by a back pain specialist will undergo physical examination maneuvers and a test lidocaine injection of the joint. Patients who meet eligibility requirements will be randomized in a single-blind randomized controlled manner with a 50% chance of receiving platelet-rich plasma versus steroid/anesthetic injection of the sacroiliac joint(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich Plasma | Experimental | Procedure: Sacroiliac intra-articular injectionPatients will receive an intra-articular injection 3 mL of autologous platelet-rich plasma in the sacroiliac joint. |
| Steroid/Anesthetic | Active comparator | Procedure: Sacroiliac intra-articular injectionPatients will receive an intra-articular injection 40 mg Depo-medrol mixed with 2 mL 0.25% bupivicaine in the sacroiliac joint. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (>18 y/o) males and females referred for therapeutic injection to the investigators spine interventional service by a physiatrist or pain anesthesiologist with a clinical diagnosis of SIJ pain confirmed by history
- 50% or greater reduction in pain by a diagnostic anesthetic block using no more than 1.5 cc 2% lidocaine performed under imaging guidance by a pain interventionalist (PM\&R, Pain Anesthesia, or Neuroradiology Spine Intervention).
- Baseline pain must be >/=4 by numeric rating scale (NRS), at least 6 weeks in chronicity, and must not be multi-factorial (related to radiculopathy or axial pain localizing elsewhere) by physical examination or confounding medical history (infection, inflammatory spondyloarthropathy, or osseous metastatic disease).
Key exclusion criteria (4 listed)
- SIJ steroid treatment within the prior 6 months.
- Patients with a history of infection currently on antibiotic therapy
- Usage of systemic immunosuppressants
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacroiliac intra-articular injectionCT guided injection of platelet-rich plasma versus steroid/anesthetic into the sacroiliac joint | Procedure or surgery | Platelet-rich Plasma, Steroid/Anesthetic |
Primary outcome
Numeric Rating Scale
Time frame: Change between baseline and 3-months post-intervention
Validated pain scale rating pain on a scale of 0 through 10. 0 for no pain, and 10 for the highest pain the patient can imagine.
4 secondary outcomes
Modified Oswestry Disability Questionnaire
Time frame: Change between baseline and 3-months post-intervention
Short-Form 12 Survey
Time frame: Change between baseline and 3-months post-intervention
Functional testing
Time frame: Change between baseline and 3-months post-intervention
Opiate/pain medication usage questionnaire
Time frame: Change between baseline and 3-months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miriam Peckham, MD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sacroiliac intra-articular injection in people with Low Back Pain and Sacroiliac Joint Synovitis, run by University of Utah at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Change between baseline and 3-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.