Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Degenerative disc disease (DDD) is a common condition of the spine that can cause short or long term back pain. DDD frequently affects the lower back, and is a major cause of low back pain. The spine is made up of a column of bones (vertebrae), and between each vertebra there is a gel-filled disc. These discs cushion the vertebrae and act as ‘shock absorbers’, preventing the vertebrae from rubbing together. They also give the spine a degree of mobility. As people age, their discs become smaller and less flexible, which decreases the disc’s ability to cushion the spine. Also, over time many people accumulate small ‘wear and tear’ injuries to their discs; unfortunately, discs are unable to heal themselves, so small injuries can become much worse over time. Despite DDD being very common, an effective treatment has not yet been established; many treatment strategies are aimed at managing the symptoms of DDD. A new treatment has recently been developed called platelet-rich plasma (PRP) therapy, which shows great promise in treating conditions such as knee and hip arthritis. In PRP therapy, blood is taken from the patient and then processed in a laboratory to separate the PRP component of it. PRP contains a concentration of various growth factors which are known to stimulate healing and tissue repair. The PRP portion is then re-injected into the patient at the site of injury. The aim of this small preliminary study is to see how effective and safe PRP therapy is when used to treat DDD.

Who can participate?
Adults diagnosed with DDD or experiencing chronic lower back pain for more than 3 months.

What does the study involve?
All participants are given a PRP injection into their affected spinal discs. Participants are asked to complete questionnaires and perform physical assessments before treatment, then again at 4, 8, 16, 24, 32, 40 and 48 weeks following treatment.

What are the possible benefits and risks of participating?
Participants will benefit from receiving PRP therapy at no cost. Potential risks of participation include the possibility of neurological deterioration or discitis in the treated discs.

Where is the study run from?
Mie University Hospital (Japan)

When is the study starting and how long is it expected to run for?
April 2009 to May 2012

Who is funding the study?
Ministry of Education, Culture, Sports, Science and Technology (Japan)

Who is the main contact?
Dr K Akeda

Trial website

Contact information



Primary contact

Dr Koji Akeda


Contact details

Mie University Graduate School of Medicine
Department of Orthopedic Surgery
2-174 Edobashi

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

Platelet-rich plasma (PRP) has the potential to repair degenerated intervertebral discs. Intradiscal injection of PRP for the treatment of low back pain patients with degenerated intervertebral discs would be a safe and effective treatment.

Ethics approval

Ethics Committee of Mie University Hospital, 04/07/2008, ref: 936.

Study design

Phase I prospective feasibility study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.


Degenerative disc disease


One intradiscal injection of autologous platelet-rich plasma.

Intervention type



Drug names

Primary outcome measure

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.

Secondary outcome measures

VAS pain score.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

More than ten participants

Participant exclusion criteria

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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Mie University Hospital
1577 Kurimamachiya-cho

Sponsor information


Mie University Graduate School of Medicine

Sponsor details

Department of Orthopaedic Surgery
2-174 Edobashi

Sponsor type




Funder type


Funder name

Ministry of Education, Culture, Sports, Science and Technology (Japan)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Preliminary results will be submitted mid-2015.

Intention to publish date


Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes