Intervertebral disc regeneration using platelet-rich plasma

Regenerative therapy of intervertebral disc using platelet-rich plasma growth factors

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64752662

Enrollment

Registered

2015-05-23

Start date

2008-05-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative disc disease Musculoskeletal Diseases Intervertebral disc degeneration

Interventions

One intradiscal injection of autologous platelet-rich plasma.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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: 1. Visual analog scale (VAS) for back pain 2. Roland-Morris Disability Questionnaire (RDQ) for back pain-related disability 3. Neurological assessments (motor strength, sensory function and reflexes) Safety assessment: the safety of this treatment will be evaluated in terms of neurological changes. Radiological examination includes: 1. Changes in disc height, lumbar lordosis angle, MRI morphology and T2-value. 2. The presence or absence of adverse events will also be evaluated through the follow-up period.	—

Measure

Time frame

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: 1. Visual analog scale (VAS) for back pain 2. Roland-Morris Disability Questionnaire (RDQ) for back pain-related disability 3. Neurological assessments (motor strength, sensory function and reflexes) Safety assessment: the safety of this treatment will be evaluated in terms of neurological changes. Radiological examination includes: 1. Changes in disc height, lumbar lordosis angle, MRI morphology and T2-value. 2. The presence or absence of adverse events will also be evaluated through the follow-up period.

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Secondary

Measure	Time frame
VAS pain score.	—

Countries

Japan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026