Platelet-Rich PlasmaEarly Phase 1NCT04522674
Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Lumbar Facet Syndrome of the Spine
A Early Phase 1 study testing Autologous platelet rich plasma in people with Platelet-Rich Plasma, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Platelet-Rich Plasma
- What is being tested?
- Autologous platelet rich plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2021to 28 Apr 2022
- Phase
- Early Phase 1
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspicion of z-joint mediated low back pain
- Pain rating of ≥4/10 on a VAS scale
- Symptom duration of 3 or more months
- Failed conservative therapy (minimum of PT and pain medications)
- Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.
Who cannot join
- Inability to undergo fluoroscopically guided procedures
- Current pregnancy
- Prior spinal surgery with hardware
- Intolerance to local anesthesia, contrast medium, or blood derivatives
- Local or systemic infection or spinal infection
- Irreversible coagulopathy
Show all 12Show fewer
- Patients that require strict anticoagulation and cannot be off antiplatelet medication for at least a week
- Less than 18 years of age
- Corticosteroid shot within last 3 months into affected lumbar facet joint because of concern of damage to cartilage in the joint in that time period.
- Patients with workman compensation related back pain
- Patients with rheumatic cause of lumbar facet arthritis.
- Patients who have had a radiofrequency neurotomy of the nerves innervating their affected facet joints within the last year
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Medicine Spine Center
Aurora, Colorado, 80045
About this study
Official title: A Pilot Trial Evaluating the Feasibility of Using Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Osteoarthritis of the Lumbar Facet Joint(s) of the Spine
The purpose of this study is to investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function.
- Conditions
- Platelet-Rich Plasma
- Being tested
- Autologous platelet rich plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet rich plasmaBiological
0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome
| Study group | Role | What they receive |
|---|---|---|
| Autologous platelet rich plasma | Experimental | 0.5 mL of activated autologous PRP will be injected by fluoroscopic guidance into the affected lumbar facet joint (s) depending on the number of affected levels. A max of 4 joints will be injected per patient. Receives: Biological: Autologous platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.
Pain as assessed from 0-10. Where 10 is severe pain and 0 is no pain. Improvement of pain by 50% after intervention is defined as treatment success
Measured: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
PROMIS Survey for Low Back Pain Function (PROMIS-29)
NIH validated PROMIS score for physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, pain interference, and pain intensity (PROMIS- 29 Profile v2.0). A higher PROMIS T-score represents more of the concept being measured.For negatively-worded concepts like Anxiety,a T-score of 60 is one SD worse than average.By comparison,an Anxiety T-score of 40 is one SD better than average.However,for positively-worded concepts like Physical Function-Mobility,a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.
Measured: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
Secondary outcomes (3)
Length of enrollment of 10 patients and attrition rate
Determine percentage of patients who enroll in the study, how long it takes to enroll 10 patients, and attrition rate of patients in a 3 month time period
Measured: 3 months
Safety as measured by number of subjects with at least one adverse event
Monitoring of adverse events such as bleeding, infection, allergy, neurologic deficits, and injection-related complications.
Measured: 3 months
Degree of improvement in pain and function based on severity of lumbar facet OA.
Using the surveys from the primary outcome, the investigators plan to perform a subgroup analysis depending on the severity of lumbar facet OA as seen by imaging
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start19 Feb 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet-Rich PlasmaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Venu R Akuthota, MD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522674
- Sponsor's protocol ID
- 19-3066
- Status last verified
- May 2022
- First submitted
- 17 Aug 2020
- Last updated
- 4 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial Evaluating the Feasibility of Using Platelet-Rich Plasma (PRP) for Treatment of Symptomatic Osteoarthritis of the Lumbar Facet Joint(s) of the Spine
- ClinicalTrials.gov ID
- NCT04522674
- Acronym / sponsor ID
- 19-3066
- Conditions
- Platelet-Rich Plasma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 21 Aug 2020 (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 investigate the feasibility of standardized autologous platelet rich plasma injections into osteoarthritic lumbar facet joints to treat back pain and improve patient function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous platelet rich plasma | Experimental | Biological: Autologous platelet rich plasma0.5 mL of activated autologous PRP will be injected by fluoroscopic guidance into the affected lumbar facet joint (s) depending on the number of affected levels. A max of 4 joints will be injected per patient. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Suspicion of z-joint mediated low back pain
- Pain rating of ≥4/10 on a VAS scale
- Symptom duration of 3 or more months
- Failed conservative therapy (minimum of PT and pain medications)
- Have diagnosis of lumbar facet syndrome after MRI, X-ray, or CT imaging of any severity and a medial branch block with local anesthetic that confirms lumbar facet pathology.
Key exclusion criteria (12 listed)
- Inability to undergo fluoroscopically guided procedures
- Current pregnancy
- Prior spinal surgery with hardware
- Intolerance to local anesthesia, contrast medium, or blood derivatives
- Local or systemic infection or spinal infection
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 |
|---|---|---|
| Autologous platelet rich plasma0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome | Biological | Autologous platelet rich plasma |
Primary outcome
Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time.
Time frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
Pain as assessed from 0-10. Where 10 is severe pain and 0 is no pain. Improvement of pain by 50% after intervention is defined as treatment success
PROMIS Survey for Low Back Pain Function (PROMIS-29)
Time frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention
NIH validated PROMIS score for physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social activities, pain interference, and pain intensity (PROMIS- 29 Profile v2.0). A higher PROMIS T-score represents more of the concept being measured.For negatively-worded concepts like Anxiety,a T-score of 60 is one SD worse than average.By comparison,an Anxiety T-score of 40 is one SD better than average.However,for positively-worded concepts like Physical Function-Mobility,a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.
3 secondary outcomes
Length of enrollment of 10 patients and attrition rate
Time frame: 3 months
Safety as measured by number of subjects with at least one adverse event
Time frame: 3 months
Degree of improvement in pain and function based on severity of lumbar facet OA.
Time frame: 3 months
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 4 May 2022.
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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.
Venu R Akuthota, MD principal investigator
University of Colorado School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous platelet rich plasma in people with Platelet-Rich Plasma, run by University of Colorado, Denver at 1 site 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 5 inclusion and 12 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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in pain Visual Analog Score with back flexion and at rest from baseline after intervention over time. (time frame: Baseline, immediately after intervention, 1 week, 1 month, and 3 months post intervention). The study lists 2 primary outcomes in all. 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 4 May 2022.