Condition category
Signs and Symptoms
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
21/04/2015
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 S Eldabe

ORCID ID

Contact details

South Tees Hospitals NHS Trust
The James Cook University Hospital
Anaesthetics
Cheriton House
Marton Road
Middlesbrough
Cleveland
TS4 3BW
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0227170368

Study information

Scientific title

Patient satisfaction with stimulation sensation and coverage comparing single versus dual channel stimulation in the Synergy® system

Acronym

Study hypothesis

Does dual channel stimulation improve subjective coverage of the pain area with paraesthesias and therefore patient satisfaction with the stimulator?

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Signs and Symptoms: Pain

Intervention

20 patients already implanted with Synergy Spinal Cord Stimulation (SCS) device for pain relief will be recruited. Baseline data will be collected for paraesthesia coverage and patient satisfaction (0-100mm line) as well as Global perceived effect (1-7 scale). The patient will then be randomised by means of sealed envelopes to 2 groups.

Group A patients, will be seen by the PI and will have their Synergy device programmed to deliver single channel stimulation for 2 weeks then dual channel stimulation for 2 weeks.

Group B patients will have the opposite sequence. At the end of each 2-week period the questionnaires administered at baseline will be re-administered by a blinded observer.

Patients will be unaware of their mode of programming throughout the study.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Patient satisfaction score (0-100mm line)
2. Paraesthesia coverage (0-100mm line)
3. Global perceived effect (1-7)

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2005

Overall trial end date

31/10/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient implanted with Synergy stimulator
2. Patient willing to take part in the study

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Sample size = 20

Participant exclusion criteria

1. Patient implanted with single channel stimulator
2. Patient unwilling to take part in the study

Recruitment start date

01/10/2005

Recruitment end date

31/10/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South Tees Hospitals NHS Trust
Cleveland
TS4 3BW
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

South Tees Hospitals NHS 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