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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
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 | 2019/11/11 |
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 |
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Condition | ||
Condition | low back pain | |
Classification by specialty |
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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. |
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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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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 | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Management information | |||||||
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Last modified on |
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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 |