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
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
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
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
