UMIN-CTR Clinical Trial

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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