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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038536
Receipt No. 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

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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
Institute Mie University Hospital
Institute
Department

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
URL(English) https://upload.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


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