NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs043190014

Registered date:10/04/2019

Intervertebral disc therapy using PRP-releasate

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedLow back pain with intervertabral disc degeneration
Date of first enrollment16/02/2018
Target sample size20
Countries of recruitment
Study typeInterventional
Intervention(s)Under fluoroscopy, a 22 gauge, 150-mm spinal needle was inserted into the center of the targeted disc. Group A: PRP releasate, 2 mL, was injected through a syringe filer (Millex GV Filter unit, Cat. #SLGV M33 RS, Millipore, Billerica, MA, USA). Group B: Betamethasone sodium phosphate (Rinderon, Sionogi & Co., LTD) (2 mg, 0.5 ml) + saline (1.5 ml)

Outcome(s)

Primary OutcomeChange in VAS (Visual Analogue Scale) at 8 weeks after the injection from VAS at baseline
Secondary OutcomeChange 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.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaHaving 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
Exclude criteriaHaving 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

Related Information

Contact

Public contact
Name Koji Akeda
Address 2-174 Edobashi, Tsu, Mie Mie Japan 514-8507
Telephone +81-59-231-5022
E-mail k_akeda@clin.medic.mie-u.ac.jp
Affiliation Mie University Hospital
Scientific contact
Name Koji Akeda
Address 2-174 Edobashi, Tsu, Mie Mie Japan 514-8507
Telephone +81-59-231-5022
E-mail k_akeda@clin.medic.mie-u.ac.jp
Affiliation Mie University Hospital