UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038536
Receipt number R000043907
Scientific Title Intradiscal injection therapy of platelet-rich plasma (PRP) - releasate for the patients with discogenic low back pain: Randomized control study
Date of disclosure of the study information 2020/12/01
Last modified on 2021/09/02 14:36:28

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Basic information

Public title

Intervertebral disc therapy using PRP-releasate

Acronym

IDTP

Scientific Title

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

Scientific Title:Acronym

IDTPRCS

Region

Japan


Condition

Condition

low back pain

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Randomized control study to determine the efficacy of PRP-releasate for the patients with discogenic low back pain.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase III


Assessment

Primary outcomes

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

Key secondary outcomes

Change in VAS (Visual Analogue Scale) at 4, 12, 26, 52 weeks after the injection from VAS at baseline.
Percent change in VAS at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline.
Change and % change in ODI (Oswestry Disability Index) at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline.
Change in VAS (Visual Analogue Scale) at 4, 12, 26, 52 weeks after the injection from VAS at baseline.
Percent (%) change in VAS at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline.
Change and % change in ODI (Oswestry Disability Index) at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline.
Change and % change in the Roland-Morris Disability Questionnaire (RDQ) at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline.
Change and % change in JOA Back Pain Evaluation Questionnaire (JOABPEQ) at 4, 8, 12, 26, 52 weeks after the injection from VAS at baseline.
Change in MRI grading at 26 and 52 weeks after the injection from bassline.
Change in radiographic disc height at 4, 8, 12, 26, 52 weeks after the injection from that at baseline.
Frequency and amount in use of short-term NSAIDs until 4, 8, 12, 26, 52 weeks after the injection
A successful ratio of the treatment at 8, 12, 26, 52 weeks after the treatment.

*When the subjects receive the optional treatment, the secondary outcomes are evaluated at 4, 8, 12, 26, 52 weeks after the optional treatment.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification

NO

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Group A: PRP releasate, 2 mL, was injected through a syringe filer (Millex GV Filter unit, Cat. #SLGV M33 RS, Millipore, Billerica, MA, USA).

Interventions/Control_2

Group B: Betamethasone sodium phosphate (Rinderon, Sionogi & Co., LTD) (2 mg, 0.5 ml) + saline (1.5 ml)

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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

Key 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

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Koji
Middle name
Last name Akeda

Organization

Mie University Hospital

Division name

Orthopaedic Surgery

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie

TEL

059-231-5022

Email

k_akeda@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name Koji
Middle name
Last name Akeda

Organization

Mie University Hospital

Division name

Orthopaedic Surgery

Zip code

514-8507

Address

2-174 Edobashi, Tsu, Mie

TEL

059-231-5022

Homepage URL


Email

k_akeda@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Hospital

Institute

Department

Personal name



Funding Source

Organization

Okasan-Kato fundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Mie University Hospital Clinical Research Review Board

Address

2-174 Edobashi, Tsu, Mie, Japan Mie, Mie

Tel

059-231-5045

Email

kk-sien@mo.medic.mie-u.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

17

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 11 Month 16 Day

Date of IRB

2017 Year 06 Month 08 Day

Anticipated trial start date

2018 Year 02 Month 20 Day

Last follow-up date

2020 Year 09 Month 23 Day

Date of closure to data entry

2021 Year 08 Month 19 Day

Date trial data considered complete

2021 Year 08 Month 19 Day

Date analysis concluded

2021 Year 08 Month 19 Day


Other

Other related information



Management information

Registered date

2019 Year 11 Month 11 Day

Last modified on

2021 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043907


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name