NCT03197415

Brief Summary

This study aims to evaluate the effect of platelet-rich plasma (PRP) on discogenic low back pain by comparing the pre- and post-interventional outcomes in patients receiving intradiscal injection of autologous PRP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2019

Completed
Last Updated

September 6, 2019

Status Verified

September 1, 2019

Enrollment Period

2.9 years

First QC Date

April 13, 2017

Last Update Submit

September 5, 2019

Conditions

Discogenic PainPlatelet-rich Plasma

Keywords

Platelet-rich plasmaIntervertebral Disc DegenerationLow Back Pain

Outcome Measures

Primary Outcomes (1)

  • 1-month postoperative function evaluated by Oswestry Disability Index

    Function is evaluated using Oswestry Disability Index.

    1-month postoperative

Secondary Outcomes (3)

  • 4-month postoperative function evaluated by Oswestry Disability Index

    4-month postoperative

  • 1-month postoperative pain evaluated by visual analogue scale

    1-month postoperative

  • 4-month postoperative pain evaluated by visual analogue scale

    4-month postoperative

Study Arms (1)

PRP group

EXPERIMENTAL

Intradisc injection of autologous platelet-rich plasma gel

Other: Platelet-rich plasma

Interventions

Platelet-rich plasmaOTHER

intradiscal injection of plasma-rich platelet

PRP group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 20 and 60 years
  • L-spine disc degeneration diagnosed by MRI
  • Low back pain

You may not qualify if:

  • Herniated disc
  • With prior history of spine surgery
  • With current or prior history of cancer
  • With current or prior history of hematological disease
  • Pregnancy
  • Patients who will not cooperate with one-year followup

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Show Chwan Memorial Hospital

Changhua, Changhua, 500, Taiwan

Location

MeSH Terms

Conditions

Intervertebral Disc DegenerationLow Back Pain

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesBack PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pei-Yuan Lee, MD

    Show Chwan Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Superintendent

Study Record Dates

First Submitted

April 13, 2017

First Posted

June 23, 2017

Study Start

April 22, 2016

Primary Completion

March 25, 2019

Study Completion

March 25, 2019

Last Updated

September 6, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)