Intervertebral disc therapy using PRP-releasate

Phase 2

• Conditions: ow back pain with intervertabral disc degeneration; Discogenic low back pain

• Registration Number: JPRN-jRCTs043190014
• Lead Sponsor: Akeda Koji

Brief Summary

The intradiscal injection of PRPr showed clinically significant improvements in LBP intensity (more than 30% reduction) in patients with discogenic LBP, similar to those injected with glucocorticoid at eight weeks post-injection. PRPr treatment was safe and maintained improvements in pain, disability, and QOL during 60 weeks follow-up.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-10
• Study Completion: 2020-09-23
• Results First Posted: 2022-01-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Having low back pain more than three month
Visual analogue scare (VAS): more than 40% at baseline
ODI: more than 40% at bassline
Disc degeneration evaluated by MRI (more than grade II by Pfirrmann grading) from L3/4 to L4/5 lumbar disc
Less than 50% decrease of disc height measurement by lumbar radiograph
Discogenic pain evaluated by provocative discography
Written informed consent is obtained from the participant of this study

Exclusion Criteria

Having remarkable cauda equine and neuropathy symptom
Having systematic or spinal infection
Past-history of lumbar surgeries
Past-history of interventional intervertebral disc therapy
Having intervertebral instability evaluated by lumbar radiograph
Patients having spondylolisthesis (more than grade I by Meyerding classification)
Having neuro-muscular diseases, cerebral diseases, malignant tumor and blood coagulation disorders
High risk for infectious diseases after the treatment
Having anti-coagulant drugs at the time of treatment
Pregnant patient
Difficulty in participating throughout the evaluation period
More than 10-points of BS-POS questionnaire test
Contraindication for MRI
Inappropriate patient for clinical study evaluate by doctors

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in VAS (Visual Analogue Scale) at 8 weeks after the injection from VAS at baseline