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Clinical Trials/JPRN-jRCTs043190014
JPRN-jRCTs043190014
Completed
Phase 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 enrollmentApril 10, 2019
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Conditionsow back pain with intervertabral disc degenerationDiscogenic low back pain

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
ow back pain with intervertabral disc degeneration
Sponsor
Akeda Koji
Enrollment
16
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

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.

Registry
who.int
Start Date
April 10, 2019
End Date
September 23, 2020
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Akeda Koji

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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