Trial Outcomes & Findings for Intradiscal Platelet Rich Plasma (NCT NCT04544709)

NCT ID: NCT04544709

Last Updated: 2023-12-11

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 3 participants
• Primary outcome timeframe: 2 months
• Results posted on: 2023-12-11

Participant Flow

Generally recruited through the University of Utah Orthopaedic Center.

Participant milestones

Measure	Standard of Care Intradiscal PRP Injections There was only one group. All participants had standard-of-care intradiscal PRP injections.
Overall Study STARTED	3
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Standard of Care Intradiscal PRP Injections There was only one group. All participants had standard-of-care intradiscal PRP injections.
Overall Study The study was discontinued due to low enrollment.	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Standard of Care Intradiscal Platelet-Rich Plasma (PRP) Injections n=3 Participants 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.
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=3 Participants
Sex: Female, Male Female	0 Participants n=3 Participants
Sex: Female, Male Male	3 Participants n=3 Participants
Region of Enrollment United States	3 participants n=3 Participants
Height	185.4 centimeters n=3 Participants
Weight	87.5 kilograms n=3 Participants
Duration of Pain 1-2 years	1 Participants n=3 Participants
Duration of Pain 3-5 years	2 Participants n=3 Participants
Radiologic Diagnosis Based on MRI of the Lumbar Spine? Yes	2 Participants n=3 Participants
Radiologic Diagnosis Based on MRI of the Lumbar Spine? No	1 Participants n=3 Participants
Numeric Rating Scale Low Back Pain Score Current low back pain score	4.0 units on a scale n=3 Participants
Numeric Rating Scale Low Back Pain Score 7-day average low back pain score	3.0 units on a scale n=3 Participants
Numeric Rating Scale Leg Pain Score Current leg pain score	1.0 units on a scale n=3 Participants
Numeric Rating Scale Leg Pain Score 7-day average leg pain score	2.0 units on a scale n=3 Participants
Oswestry Disability Index Score	9.0 units on a scale n=3 Participants
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Score	190.0 units on a scale n=3 Participants
PROMIS PF CAT Score	42.3 units on a scale n=3 Participants
PROMIS Global Health Score	33.0 units on a scale n=3 Participants
Medication Quantification Scale (MQS) III Score	10.2 units on a scale n=3 Participants
Daily Morphine Equivalent Dose	0.0 milligrams of morphine n=3 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Presented here are primary outcome data collected from the 3 participants before the study was discontinued due to very low enrollment numbers.

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.

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Numeric Rating Scale for Low Back Pain at 2-Month Follow-up Proportion of participants with ≥80% reduction in low back pain NRS score	2 Participants
Numeric Rating Scale for Low Back Pain at 2-Month Follow-up Proportion of participants with ≥50% reduction in low back pain NRS score	2 Participants

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

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.

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score 1 month	-1 units on a scale Interval -1.0 to -1.0
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score 2 months	-3 units on a scale Interval -4.0 to -1.0
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score 3 months	-2 units on a scale Interval -3.0 to -1.0
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score 6 months	-2 units on a scale Interval -3.0 to -1.0
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score 9 months	-2 units on a scale Interval -2.0 to -2.0
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score 12 months	-3 units on a scale Interval -3.0 to -3.0
Median Change in Low Back Pain Numeric Rating Scale (NRS) Score 24 months	-3 units on a scale Interval -3.0 to -3.0

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

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.

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI) 2 months	2 Participants
Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI) 3 months	1 Participants
Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI) 6 months	1 Participants
Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI) 9 months	2 Participants
Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI) 12 months	2 Participants
Proportion of Patients With ≥30% Improvement From Baseline on the Oswestry Disability Index (ODI) 24 months	2 Participants

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

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").

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC) 1 month	1 Participants
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC) 2 months	2 Participants
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC) 3 months	1 Participants
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC) 6 months	2 Participants
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC) 9 months	2 Participants
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC) 12 months	2 Participants
Proportion of Patients With a ≥6 Score on Patient Global Impression of Change (PGIC) 24 months	2 Participants

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

A score of 6.8 points on the MQS III is equivalent to approximately 10 daily morphine equivalents

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points 9 months	2 Participants
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points 1 month	2 Participants
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points 2 months	1 Participants
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points 3 months	2 Participants
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points 6 months	2 Participants
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points 12 months	2 Participants
Proportion of Patients With a Medication Quantification Scale (MQS) III Score Reduction From Baseline of ≥6.8 Points 24 months	2 Participants

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

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.

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Oswestry Disability Index (ODI) Change Scores 2 months	-9.0 score on a scale Interval -12.0 to 2.0
Oswestry Disability Index (ODI) Change Scores 3 months	-4.0 score on a scale Interval -12.0 to 4.0
Oswestry Disability Index (ODI) Change Scores 6 months	-6.5 score on a scale Interval -13.0 to 0.0
Oswestry Disability Index (ODI) Change Scores 9 months	-8.0 score on a scale Interval -12.0 to -4.0
Oswestry Disability Index (ODI) Change Scores 12 months	-9.5 score on a scale Interval -13.0 to -6.0
Oswestry Disability Index (ODI) Change Scores 24 months	-9.5 score on a scale Interval -11.0 to -8.0

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

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.

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
PROMIS PF CAT Change Scores 1 month	6.3 score on a scale Interval 5.1 to 7.4
PROMIS PF CAT Change Scores 2 months	12.5 score on a scale Interval -1.6 to 25.2
PROMIS PF CAT Change Scores 3 months	6.2 score on a scale Interval -0.1 to 12.5
PROMIS PF CAT Change Scores 6 months	11.3 score on a scale Interval -2.4 to 24.9
PROMIS PF CAT Change Scores 9 months	8.7 score on a scale Interval 4.4 to 13.0
PROMIS PF CAT Change Scores 12 months	11.6 score on a scale Interval 9.1 to 14.1
PROMIS PF CAT Change Scores 24 months	15.9 score on a scale Interval 14.1 to 17.7

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

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.

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores 1 month	-175.0 score on a scale Interval -220.0 to -130.0
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores 2 months	-111.0 score on a scale Interval -187.0 to -21.0
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores 3 months	-153.0 score on a scale Interval -195.0 to -111.0
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores 6 months	-163.0 score on a scale Interval -170.0 to -156.0
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores 9 months	-186.5 score on a scale Interval -233.0 to -140.0
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores 12 months	-178.5 score on a scale Interval -237.0 to -120.0
Pain and Sleep Questionnaire 3-Item Index (PSQ-3) Change Scores 24 months	-200.5 score on a scale Interval -231.0 to -170.0

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

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".

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Patient Satisfaction Scores 1 month	5.0 score on a scale Interval 5.0 to 5.0
Patient Satisfaction Scores 2 months	5.0 score on a scale Interval 4.0 to 5.0
Patient Satisfaction Scores 3 months	4.5 score on a scale Interval 4.0 to 5.0
Patient Satisfaction Scores 6 months	5.0 score on a scale Interval 5.0 to 5.0
Patient Satisfaction Scores 9 months	5.0 score on a scale Interval 5.0 to 5.0
Patient Satisfaction Scores 12 months	5.0 score on a scale Interval 5.0 to 5.0
Patient Satisfaction Scores 24 months	5.0 score on a scale Interval 5.0 to 5.0

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

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".

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Patient Global Impression of Change (PGIC) Scores 1 month	6.5 score on a scale Interval 6.0 to 7.0
Patient Global Impression of Change (PGIC) Scores 2 months	6.0 score on a scale Interval 5.0 to 7.0
Patient Global Impression of Change (PGIC) Scores 3 months	6.0 score on a scale Interval 5.0 to 7.0
Patient Global Impression of Change (PGIC) Scores 6 months	6.5 score on a scale Interval 6.0 to 7.0
Patient Global Impression of Change (PGIC) Scores 9 months	7.0 score on a scale Interval 7.0 to 7.0
Patient Global Impression of Change (PGIC) Scores 12 months	7.0 score on a scale Interval 7.0 to 7.0
Patient Global Impression of Change (PGIC) Scores 24 months	7.0 score on a scale Interval 7.0 to 7.0

SECONDARY outcome

Timeframe: 1 month, 2 months, 3 months, 6 months, 9 months, 12 months, 24 months, 36 months

Population: 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.

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Opioid Consumption in Daily Morphine Equivalents 24 months	0 milligrams of morphine Interval 0.0 to 0.0
Opioid Consumption in Daily Morphine Equivalents 1 month	0 milligrams of morphine Interval 0.0 to 0.0
Opioid Consumption in Daily Morphine Equivalents 2 months	0 milligrams of morphine Interval 0.0 to 0.0
Opioid Consumption in Daily Morphine Equivalents 3 months	0 milligrams of morphine Interval 0.0 to 0.0
Opioid Consumption in Daily Morphine Equivalents 6 months	0 milligrams of morphine Interval 0.0 to 0.0
Opioid Consumption in Daily Morphine Equivalents 9 months	0 milligrams of morphine Interval 0.0 to 0.0
Opioid Consumption in Daily Morphine Equivalents 12 months	0 milligrams of morphine Interval 0.0 to 0.0

SECONDARY outcome

Timeframe: 24 months, 36 months

Population: 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).

Outcome measures

Measure	Standard-of-care Intradiscal PRP Injections n=3 Participants There was only 1 group. All participants had standard-of-care intradiscal PRP injections
Proportion of Patients Who Underwent Lumbar Spinal Surgery During the Study Period 24 months	0 Participants

Adverse Events

Standard-of-care Intradiscal PRP Injections

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heather Littell, Regulatory Coordinator

University of Utah Orthopaedics Center

Phone: 801-587-5432

Email: u6041929@utah.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place