Discogenic PainPhase 4NCT04544709
Intradiscal Platelet Rich Plasma
A Phase 4 study testing Low back intradiscal injection of platelet rich plasma (PRP) in people with Discogenic Pain and Low Back Pain, run by University of Utah at 1 site in United States.
Trial summary
To assess changes in pain and function in patients with discogenic low back pain after a standard of care intradiscal injection of Platelet-Rich Plasma (PRP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discogenic Pain, Low Back Pain, Chronic Pain
- What is being tested?
- Low back intradiscal injection of platelet rich plasma (PRP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 29 Jul 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age greater than 18 years of age at day of enrollment.
- Clinical diagnosis of refractory discogenic low back pain for >3 months.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs or positive lumbar provocative discography according to SIS/IASP standards at one or two levels.
- Back pain greater than leg pain with an intensity of at least 4/10 or higher using the Numerical Rating Scale (NRS).
- Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months.
Who cannot join
- Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study.
- Contraindications to intradiscal injection of PRP (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding).
- More than 2 levels of clinical or discogram proven pain.
- Non-discogenic source of low back pain as identified by separate diagnostic blocks.
- Negative lumbar provocation discography.
- Active moderate to severe lumbar radiculopathy.
Show all 28Show fewer
- Intradural disc herniation.
- Spinal fracture within the past 6 months.
- Steroid injection in the spine within the last 30 days.
- Any intradiscal injection other than contrast dye or anesthetic in the last 30 days.
- Prior fusion at level considered to be the source of the pain.
- Prior lumbar spine surgery within the last 6 months.
- AP diameter of spinal canal less than or equal to 9mm at level to be treated.
- Severe uncontrolled medical condition.
- Moderate to severe hepatic dysfunction.
- Severe psychological illness.
- History of Inflammatory arthritis.
- Malignancy within past 5 years except basal cell or squamous cell skin cancer.
- Current use of equal to greater than 30mg morphine-equivalent per day of opioid use.
- A history of alcohol or drug abuse within past 5 years.
- Use of any investigational drug within past 30 days.
- A known allergy or sensitivity to citrate (used for processing PRP).
- Severe anaphylactic/anaphylactoid reaction to any medications used.
- Pending litigation involving subject's back pain.
- No insurance coverage for any subsequent tests or procedures.
- Disc protrusion greater than 5mm from base of vertebral body.
- Greater than 50% disc height loss at involved level(s).
- Inability or unwillingness to continue rehabilitation protocols.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain
To assess changes in pain and function in patients with discogenic low back pain after a standard of care intradiscal injection of Platelet-Rich Plasma (PRP).
Read the detailed description
Low back pain is one of a few conditions which affects all individuals through the lifespan. The etiology of low back pain is multifactorial and in many cases self-limiting, however it also is the leading cause for working age adults to be disabled with more than $87 billion spent on low back pain disorders in 2013 Lumbar disc herniation and internal disc disruption are two causes more common in these younger age groups reaching 39-42% with a predicted probability above 60% until age 50y. While the natural history of disc herniation suggests most individuals will return to a prior level of function in 3-6 months, there is a high rate of recurrent episodes which can cause short-term disability. Continued pain from a discogenic source can lead to decreased activity levels and accelerate degenerative changes in the disc and facet joints as described by Kirkaldy-Willis.
Current guidelines for treatment of axial low back pain from discogenic sources including those with radiculopathy include a 6-12-week course of conservative care including medications, therapy, acupuncture, chiropractic and exercise before an interventional paradigm of injections and/or surgical treatment. For those individuals who do not improve with conservative care and have predominately axial pain, options are limited as success rates from epidural steroid injections and surgery are 50% or less. Other treatments include chymopapain injection, intradiscal electrothermal annuloplasty (IDET), nucleoplasty, methylene blue injection, ozone injection , fibrin sealant injections. All of which have 50% or less likelihood of reducing pain more than 50%, although much of this data is from uncontrolled or prospective case-control studies only.
Platelet- rich plasma (PRP) injections stand apart from those listed above in that they are purported to be "regenerative" interventions for the diseased lumbar disc. PRP is a concentrated injectant of growth factors and anabolic factors which have in vitro and animal studies that have demonstrated upregulated proteoglycan synthesis and nucleus pulposus proliferation, restoration of disc height, healing of annular puncture wounds and anti-inflammatory effect with down regulation of TNF-alpha and IL-1. There has been limited clinical trials in humans on the effect of intradiscal PRP, including 3 trials of which 1 is a RCT and 2 are prospective series. Efficacy of intra-discal injection has shown statistically significant benefits in reduction in pain, improvement in physical function at follow-up points from 3-24 months. Each of these trials have limited sample sizes, short duration follow-up and lack of a standardized PRP preparation, making the generalizability difficult.
- Conditions
- Discogenic Pain, Low Back Pain, Chronic Pain
- Being tested
- Low back intradiscal injection of platelet rich plasma (PRP)
- Keywords
- Platelet Rich Plasma
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low back intradiscal injection of platelet rich plasma (PRP)Drug
SOC Intradiscal Lumbar PRP Procedure : A small amount of blood is drawn from you, then it is spun in a centrifuge to obtain only the platelets and few other cells. After being spun the small amount of platelets will be injected into the specific disc that is believed to be causing pain in an attempt to help reduce inflammation and pain at the site. The injection will be done under fluoroscopic guidance (x-ray) that allows very careful and precise placement of the needle.
| Study group | Role | What they receive |
|---|---|---|
| Discogenic Low Back Pain | Other | Patient with Refractory Discogenic Low back pain who will be scheduled for platelet rich plasma injection as standard of care. Receives: Drug: Low back intradiscal injection of platelet rich plasma (PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale for Low Back Pain at 2-Month Follow-up
Proportion of participants with ≥80% and ≥50% reductions from baseline in 7-day average low back pain intensity scores on the Numeric Rating Scale (NRS) at the 2-month follow-up assessment.
Measured: 2 months
Secondary outcomes (11)
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score
The Numeric Rating Scale (NRS) was used to quantify low back pain by asking patients to rate their pain intensity on an 11-point scale ranging from 0 to 10, with 0 representing "no pain at all" and 10 representing "the worst pain imaginable". NRS change scores were calculated by subtracting baseline scores from follow-up scores, so that negative change scores correspond to decreases in low back pain.
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is an instrument used in clinical and research applications to quantify disability due to low back pain as a percentage score based on patients' self-reported level of function in activities of daily living.
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC)
Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating "much improved" and "very much improved").
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points
A score of 6.8 points on the MQS III is equivalent to approximately 10 daily morphine equivalents
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Oswestry Disability Index (ODI) Change Scores
The Oswestry Disability Index (ODI) is an instrument used in clinical and research applications to quantify disability due to low back pain as a percentage score (0-100%) based on patients' self-reported level of function in activities of daily living, with higher scores indicating greater disability. ODI change scores were calculated by subtracting baseline scores from follow-up scores, so that negative change scores correspond to functional improvements.
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
PROMIS PF CAT Change Scores
Patient-Reported Outcomes Measurement Information System Physical Function Computerized Adaptive Testing (PROMIS PF CAT) measures limitations of physical activity on a scale of 0 to 100, with higher scores indicating fewer limitations. PROMIS PF CAT change scores were calculated by subtracting baseline scores from follow-up scores, so that positive change scores represent improvements to functional limitations.
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores
The 3-Item Pain and Sleep Questionnaire is an instrument used in clinical and research applications to measure the impact of pain on sleep in chronic pain populations. A higher total score (range 0 to 300) indicates a greater extent of pain-related sleep interference. PSQ-3 change scores were calculated by subtracting baseline scores from follow-up scores, so that negative change scores correspond to reductions in pain-related sleep interference.
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Patient Satisfaction Scores
The Patient Satisfaction Score represents patient satisfaction with the healthcare received using a five-point Likert scale where 1 = "very dissatisfied"; 2 = "dissatisfied"; 3 = "neither satisfied nor dissatisfied"; 4 = "satisfied"; and 5 = "very satisfied".
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Patient Global Impression of Change (PGIC) Scores
Patient Global Impression of Change (PGIC) scores represent participants' overall satisfaction after an intervention. Participants are asked to rate their perception of change on a scale of 1 to 7, where 1="very much worse", 2="much worse", 3="worse", 4="no change", 5="improved", 6="much improved", and 7="very much improved".
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Opioid Consumption in Daily Morphine Equivalents
Measured: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Proportion of Patients Who Underwent Lumbar Spinal Surgery During the Study Period
Measured: 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start14 Feb 2019
- Primary completion29 Jul 2022
- Study completion29 Jul 2022
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Discogenic PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zack McCormick, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544709
- Sponsor's protocol ID
- IRB 117455
- Status last verified
- Dec 2023
- First submitted
- 28 Aug 2020
- Last updated
- 11 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradiscal Platelet-Rich Plasma Injection for Chronic Discogenic Low Back Pain
- ClinicalTrials.gov ID
- NCT04544709
- Acronym / sponsor ID
- IRB 117455
- Conditions
- Discogenic Pain, Low Back Pain, Chronic Pain
- Keywords
- Platelet Rich Plasma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 29 Jul 2022 (actual)
- Study completion
- 29 Jul 2022 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Posted 11 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess changes in pain and function in patients with discogenic low back pain after a standard of care intradiscal injection of Platelet-Rich Plasma (PRP).
Detailed description
Low back pain is one of a few conditions which affects all individuals through the lifespan. The etiology of low back pain is multifactorial and in many cases self-limiting, however it also is the leading cause for working age adults to be disabled with more than $87 billion spent on low back pain disorders in 2013 Lumbar disc herniation and internal disc disruption are two causes more common in these younger age groups reaching 39-42% with a predicted probability above 60% until age 50y. While the natural history of disc herniation suggests most individuals will return to a prior level of function in 3-6 months, there is a high rate of recurrent episodes which can cause short-term disability. Continued pain from a discogenic source can lead to decreased activity levels and accelerate degenerative changes in the disc and facet joints as described by Kirkaldy-Willis.
Current guidelines for treatment of axial low back pain from discogenic sources including those with radiculopathy include a 6-12-week course of conservative care including medications, therapy, acupuncture, chiropractic and exercise before an interventional paradigm of injections and/or surgical treatment. For those individuals who do not improve with conservative care and have predominately axial pain, options are limited as success rates from epidural steroid injections and surgery are 50% or less. Other treatments include chymopapain injection, intradiscal electrothermal annuloplasty (IDET), nucleoplasty, methylene blue injection, ozone injection , fibrin sealant injections. All of which have 50% or less likelihood of reducing pain more than 50%, although much of this data is from uncontrolled or prospective case-control studies only.
Platelet- rich plasma (PRP) injections stand apart from those listed above in that they are purported to be "regenerative" interventions for the diseased lumbar disc. PRP is a concentrated injectant of growth factors and anabolic factors which have in vitro and animal studies that have demonstrated upregulated proteoglycan synthesis and nucleus pulposus proliferation, restoration of disc height, healing of annular puncture wounds and anti-inflammatory effect with down regulation of TNF-alpha and IL-1. There has been limited clinical trials in humans on the effect of intradiscal PRP, including 3 trials of which 1 is a RCT and 2 are prospective series. Efficacy of intra-discal injection has shown statistically significant benefits in reduction in pain, improvement in physical function at follow-up points from 3-24 months. Each of these trials have limited sample sizes, short duration follow-up and lack of a standardized PRP preparation, making the generalizability difficult.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Discogenic Low Back Pain | Other | Drug: Low back intradiscal injection of platelet rich plasma (PRP)Patient with Refractory Discogenic Low back pain who will be scheduled for platelet rich plasma injection as standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than 18 years of age at day of enrollment.
- Clinical diagnosis of refractory discogenic low back pain for >3 months.
- Magnetic resonance imaging pathology consistent with clinical symptoms/signs or positive lumbar provocative discography according to SIS/IASP standards at one or two levels.
- Back pain greater than leg pain with an intensity of at least 4/10 or higher using the Numerical Rating Scale (NRS).
- Pain duration of more than 12 weeks despite trial of conservative therapy (medications, physical therapy, or chiropractic care) for 2 months.
Key exclusion criteria (28 listed)
- Refusal to participate, provide consent, or provide follow-up information for the 24-month duration of the study.
- Contraindications to intradiscal injection of PRP (active infection, bleeding disorders, current anticoagulant or antiplatelet medication use, allergy to iodinated contrast, penicillin or clindamycin and pregnancy or breastfeeding).
- More than 2 levels of clinical or discogram proven pain.
- Non-discogenic source of low back pain as identified by separate diagnostic blocks.
- Negative lumbar provocation discography.
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 |
|---|---|---|
| Low back intradiscal injection of platelet rich plasma (PRP)SOC Intradiscal Lumbar PRP Procedure : A small amount of blood is drawn from you, then it is spun in a centrifuge to obtain only the platelets and few other cells. After being spun the small amount of platelets will be injected into the specific disc that is believed to be causing pain in an attempt to help reduce inflammation and pain at the site. The injection will be done under fluoroscopic guidance (x-ray) that allows very careful and precise placement of the needle. | Drug | Discogenic Low Back Pain |
Primary outcome
Numeric Rating Scale for Low Back Pain at 2-Month Follow-up
Time frame: 2 months
Proportion of participants with ≥80% and ≥50% reductions from baseline in 7-day average low back pain intensity scores on the Numeric Rating Scale (NRS) at the 2-month follow-up assessment.
11 secondary outcomes
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI)
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC)
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Oswestry Disability Index (ODI) Change Scores
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
PROMIS PF CAT Change Scores
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Patient Satisfaction Scores
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Patient Global Impression of Change (PGIC) Scores
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Opioid Consumption in Daily Morphine Equivalents
Time frame: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months
Proportion of Patients Who Underwent Lumbar Spinal Surgery During the Study Period
Time frame: 24 months, 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low back intradiscal injection of platelet rich plasma (PRP) in people with Discogenic Pain and Low Back Pain, run by University of Utah 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 28 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: stopped early, as of the sponsor's last update on 11 Dec 2023. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 for Low Back Pain at 2-Month Follow-up (time frame: 2 months). 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 11 Dec 2023.