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Clinical Trials/JPRN-jRCTs043190014
JPRN-jRCTs043190014CompletedPhase 2

Intradiscal injection therapy of platelet-rich plasma (PRP) - releasate for the patients with discogenic low back pain: Randomized control study - IDTPRCS

Akeda Koji0 sites16 target enrollmentStarted: April 10, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
Enrollment
16
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 18age old to ot applicable (—)
Sex
All

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

Investigators

Sponsor
Akeda Koji

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