Intervertebral disc regeneration using platelet-rich plasma

Completed

• Conditions: Degenerative disc disease; Musculoskeletal Diseases; Intervertebral disc degeneration

• Registration Number: ISRCTN64752662
• Lead Sponsor: Mie University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05-23
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Aged >18
2. Chronic low back pain without leg pain for more than 3 months
3. One or more lumbar discs (L3/L4 to L5/S1) with evidence of degenerative changes on magnetic resonance imaging (MRI) maintenance of 50% or more of normal disc height
4. At least one symptomatic disc confirmed using standardised provocative discography and/or disc block

Exclusion Criteria

1. Abnormal neurological symptoms (e.g. radiculopathy) with lumbar spinal stenosis or spondylolisthesis
2. Inflammatory arthritis (e.g. discitis)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy assessment: pain-related efficacy of this treatment will be assessed at baseline, and at 4, 8, 16, 24, 32, 40, 48 weeks following treatment:<br>1. Visual analog scale (VAS) for back pain<br>2. Roland-Morris Disability Questionnaire (RDQ) for back pain-related disability <br>3. Neurological assessments (motor strength, sensory function and reflexes)<br>Safety assessment: the safety of this treatment will be evaluated in terms of neurological changes. Radiological examination includes:<br>1. Changes in disc height, lumbar lordosis angle, MRI morphology and T2-value.<br>2. The presence or absence of adverse events will also be evaluated through the follow-up period.

Secondary Outcome Measures

Name	Time	Method
VAS pain score.