Safety study of LR-PRP administration in low back pain patients with Modic type 1 change
- Conditions
- Disc degenerative lumbar spondylosis with Modic type 1 change
- Registration Number
- JPRN-jRCTb042210159
- Lead Sponsor
- Fujita Noboyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
1 Has participated in the Informed Consent process and is willing and able to sign an informed consent
2 aged 20 to 70 years old
3 Visual Analogue Scale (VAS) pain intensity 50mm or more for more than 3 months due to low back pain caused by intervertebral disc degeneration
4 Intervertebral disc degeneration with Modic type 1 change
5 Willing and able to complete scheduled follow-up evaluations as described in the study protocol
1 BMI (Body Mass Index) : 30 or more
2 Has a blood dyscrasia (platelet (Plt) less than 50,000 /microliter)
3 Using anticoagulant or antiplatelet drug
4 Has an autoimmune disease
5 Has an active systemic inflammatory disease or infection
6 Has a polyarthralgia
7 Has an other spinal disease, including vertebral fracture
8 Has a compromised host status (diabetic, immune deficiency, chronic renal failure, hepatic cirrhosis, using immunosuppressive drug etc.)
9 Under treatment for malignant tumor
10 Is known to be pregnant
11 Judged as inappropriate subject by surgeons performing regenerative medicine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of adverse event at each study visit<br>1 Blood testing<br>2 Finding on X-ray image<br>3 Other findings
- Secondary Outcome Measures
Name Time Method Changes at each study visit from pretreatment state on all other outcomes<br>Blood testing<br>Pain VAS<br>ODI<br>RDQ<br>Disc height on plain radiograph<br>Pfirrmann classification of intervertebral discs on MRI<br>Signal change of the vertebral body end plate on MRI<br>Area of high signal region on sagittal T2 image of MRI<br>Number of utilization and dosage of analgesics<br>Correlation between patient factors and improvement of symptom