Intervertebral disc regeneration using platelet-rich plasma

ISRCTN ISRCTN64752662
DOI https://doi.org/10.1186/ISRCTN64752662
Secondary identifying numbers N/A
Submission date
14/05/2015
Registration date
23/05/2015
Last edited
22/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Koji Akeda
Scientific

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

ORCiD logoORCID ID 0000-0001-9468-9387

Study information

Study designPhase I prospective feasibility study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleRegenerative therapy of intervertebral disc using platelet-rich plasma growth factors
Study objectivesPlatelet-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(s)Ethics Committee of Mie University Hospital, 04/07/2008, ref: 936.
Health condition(s) or problem(s) studiedDegenerative disc disease
InterventionOne intradiscal injection of autologous platelet-rich plasma.
Intervention typeProcedure/Surgery
Primary outcome measureEfficacy 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 measuresVAS pain score.
Overall study start date01/04/2009
Completion date01/05/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsMore than ten participants
Key inclusion criteria1. 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
Key exclusion criteria1. Abnormal neurological symptoms (e.g. radiculopathy) with lumbar spinal stenosis or spondylolisthesis
2. Inflammatory arthritis (e.g. discitis)
Date of first enrolment01/05/2008
Date of final enrolment01/12/2011

Locations

Countries of recruitment

  • Japan

Study participating centre

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

Sponsor information

Mie University Graduate School of Medicine
University/education

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

ROR logo "ROR" https://ror.org/01529vy56

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date01/06/2015
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPreliminary results will be submitted mid-2015.
IPD sharing plan