Condition category
Musculoskeletal Diseases
Date applied
14/05/2015
Date assigned
23/05/2015
Last edited
22/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Type

Scientific

Primary contact

Dr Koji Akeda

ORCID ID

http://orcid.org/0000-0001-9468-9387

Contact details

Mie University Graduate School of Medicine
Department of Orthopedic Surgery
2-174 Edobashi
Tsu
514-8507
Japan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Degenerative disc disease

Intervention

One intradiscal injection of autologous platelet-rich plasma.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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

01/04/2009

Overall trial end date

01/05/2012

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

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

01/05/2008

Recruitment end date

01/12/2011

Locations

Countries of recruitment

Japan

Trial participating centre

Mie University Hospital
1577 Kurimamachiya-cho
Tsu
514-8507
Japan

Sponsor information

Organisation

Mie University Graduate School of Medicine

Sponsor details

Department of Orthopaedic Surgery
2-174 Edobashi
Tsu
514-8507
Japan

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Preliminary results will be submitted mid-2015.

Intention to publish date

01/06/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes