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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Orthopaedic Center | Salt Lake City | Utah | 84108 | United States |
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Generally recruited through the University of Utah Orthopaedic Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Intradiscal PRP Injections | There was only one group. All participants had standard-of-care intradiscal PRP injections. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline information was collected from 3 participants before the study was discontinued early.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care Intradiscal Platelet-Rich Plasma (PRP) Injections | There was only 1 group comprised of the 3 participants enrolled in the study before termination. All participants had standard-of-care intradiscal PRP injections. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Presented here are primary outcome data collected from the 3 participants before the study was discontinued due to very low enrollment numbers. | Posted | Count of Participants | Participants | 2 months |
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36 months
The rate of SAE's or deaths from this procedure is very low. "Utilizing fluoroscopy, the risk of nerve damage, spinal cord injury or intravascular injection is less than 1:500,000" (protocol page 5)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard-of-care Intradiscal PRP Injections | There was only 1 group. All participants had standard-of-care intradiscal PRP injections |
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The single greatest limitation is that the study was ended early due to extremely low participant enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Littell, Regulatory Coordinator | University of Utah Orthopaedics Center | 801-587-5432 | u6041929@utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 26, 2018 | Aug 16, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| 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. | 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"). | 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 | 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. | 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. | 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. | 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". | 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". | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
| Opioid Consumption in Daily Morphine Equivalents | 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 | 24 months, 36 months |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Height | Median | Full Range | centimeters |
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| Weight | Median | Full Range | kilograms |
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| Duration of Pain | Count of Participants | Participants |
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| Radiologic Diagnosis Based on MRI of the Lumbar Spine? | Count of Participants | Participants |
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| Numeric Rating Scale Low Back Pain Score | The Numeric Rating Scale 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". | Median | Full Range | units on a scale |
|
| Numeric Rating Scale Leg Pain Score | The Numeric Rating Scale (NRS) was used to quantify leg pain at baseline 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". | Median | Full Range | units on a scale |
|
| Oswestry Disability Index Score | 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. | Median | Full Range | units on a scale |
|
| Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Score | 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. | Median | Full Range | units on a scale |
|
| PROMIS PF CAT Score | 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. | Median | Full Range | units on a scale |
|
| PROMIS Global Health Score | Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health is an instrument used in clinical and research applications to provide a general assessment of health across a variety of domains. Higher scores (range 0 to 100) indicate better overall health status. | Median | Full Range | units on a scale |
|
| Medication Quantification Scale (MQS) III Score | The Medication Quantification Scale (MQS) III is used to objectively quantify and monitor pain medication use (including opioid and non-opioid medications) in chronic pain populations. The lowest possible MQS III score is 0, indicating no current usage of any analgesic drugs assessed by this instrument. It is not possible to define a maximum score value because no theoretical upper limit exists. However, higher scores reflect greater negative impacts of a pain medication regimen, and a score of 6.8 points on the MQS III is comparable to 10 daily morphine equivalents in milligrams. | Median | Full Range | units on a scale |
|
| Daily Morphine Equivalent Dose | Daily Morphine Equivalent Dose represents the amount of opioid medications that a patient is currently taking for pain, expressed as a common unit (milligrams of morphine). | Median | Full Range | milligrams of morphine |
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| Participants |
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| Secondary | 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. | One participant did not complete the 1-month assessment and was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Median | Full Range | units on a scale | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | 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. | No ODI scores were recorded at the 1-month assessment. One participant was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Count of Participants | Participants | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | 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"). | One participant did not complete the 1-month assessment and was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Count of Participants | Participants | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | 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 | One participant did not complete the 1-month assessment and was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Count of Participants | Participants | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | 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. | No ODI scores were recorded at the 1-month assessment. One participant was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Median | Full Range | score on a scale | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | 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. | One participant did not complete the 1-month assessment and was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Median | Full Range | score on a scale | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | 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. | One participant did not complete the 1-month assessment and was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Median | Full Range | score on a scale | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | 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". | One participant did not complete the 1-month assessment and was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Median | Full Range | score on a scale | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | 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". | One participant did not complete the 1-month assessment and was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Median | Full Range | score on a scale | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | Opioid Consumption in Daily Morphine Equivalents | One participant did not complete the 1-month assessment and was lost to follow-up after the 2-month assessment. For the remaining 2 participants, outcome data were collected at all follow-up time points through 2 years before the study was discontinued for low enrollment. | Posted | Median | Full Range | milligrams of morphine | 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months |
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| Secondary | Proportion of Patients Who Underwent Lumbar Spinal Surgery During the Study Period | The study was discontinued for low enrollment prior to the 36-month endpoint. No study participants had undergone lumbar spinal surgeries as of the latest follow-up assessment (24 months). | Posted | Count of Participants | Participants | 24 months, 36 months |
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