Intervertebral disc therapy using PRP-releasate

JRCT ID: jRCTs043190014

Registered date:10/04/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Low back pain with intervertabral disc degeneration
• Date of first enrollment: 16/02/2018
• Target sample size: 20
• Study type: Interventional

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 Outcome: Change in VAS (Visual Analogue Scale) at 8 weeks after the injection from VAS at baseline

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Akeda Koji
• Source(s) of Monetary Support: Okasan-Kato fundation