Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Simon Dolin

ORCID ID

Contact details

Pain Service
St Richards Hospital
Spitalfield Lane
Chichester
PO19 4SE
United Kingdom
+44 (0)1243 788122
Simon.Dolin@rws-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0213112412

Study information

Scientific title

A double blind randomised controlled crossover trial of radiofrequency annuloplasty for the treatment of low back pain

Acronym

Study hypothesis

To evaluate clinical results of patients treated with radiofrequency annuloplasty, which is used to relieve discogenic pain in the lumbar spine

Ethics approval

Not provided at time of registration

Study design

Double blind randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal Diseases: Low back pain

Intervention

Treatment group will have radiofrequency annuloplasty. Placebo group same protocol but no lesioning performed - RF generator on test mode.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2002

Overall trial end date

07/03/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. 16-70 years at first assessment
2. Moderate/severe discogenic pain
3. Oswestry disability index 20% +
4. Failed 6 months conservative treatment
5. No previous disc surgery at symptomatic levels; Body Mass Index (BMI) average or overweight range
6. Loss of disc height not >50% of normal level on Magnetic Resonance Imaging (MRI) or X-ray
7. Max two level pathology on MRI scan confirmed by discography

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/03/2002

Recruitment end date

07/03/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pain Service
Chichester
PO19 4SE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Royal West Sussex Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

28/10/2016: No publications found, verifying study status with principal investigator