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

ISRCTN	ISRCTN32625089
DOI	https://doi.org/10.1186/ISRCTN32625089
Secondary identifying numbers	N0227170368

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 21/04/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr S Eldabe
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Patient satisfaction with stimulation sensation and coverage comparing single versus dual channel stimulation in the Synergy® system
Study objectives	Does dual channel stimulation improve subjective coverage of the pain area with paraesthesias and therefore patient satisfaction with the stimulator?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/10/2005
Completion date	31/10/2007

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Sample size = 20
Key inclusion criteria	1. Patient implanted with Synergy stimulator 2. Patient willing to take part in the study
Key exclusion criteria	1. Patient implanted with single channel stimulator 2. Patient unwilling to take part in the study
Date of first enrolment	01/10/2005
Date of final enrolment	31/10/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

South Tees Hospitals NHS Trust

Cleveland
TS4 3BW
United Kingdom

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

South Tees Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan