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Register:	ISRCTN
Last refreshed on:	17 October 2016
Main ID:	ISRCTN64752662
Date of registration:	23/05/2015
Prospective Registration:	No
Primary sponsor:	Mie University Graduate School of Medicine
Public title:	Intervertebral disc regeneration using platelet-rich plasma
Scientific title:	Regenerative therapy of intervertebral disc using platelet-rich plasma growth factors
Date of first enrolment:	01/05/2008
Target sample size:	10
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN64752662
Study type:	Interventional
Study design:	Phase I prospective feasibility study (Treatment)
Phase:

Countries of recruitment
Japan

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Koji Akeda
Address:	Mie University Graduate School of Medicine Department of Orthopedic Surgery 2-174 Edobashi 514-8507 Tsu Japan
Telephone:
Email:
Affiliation:

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Degenerative disc disease
Musculoskeletal Diseases
Intervertebral disc degeneration

Intervention(s)

One intradiscal injection of autologous platelet-rich plasma.

Primary Outcome(s)

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(s)

VAS pain score.

Secondary ID(s)

N/A

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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