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 |
| Protocol serial number | N0227170368 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | South Tees Hospitals NHS Trust (UK) |
- 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
Scientific
South Tees Hospitals NHS Trust
The James Cook University Hospital
Anaesthetics
Cheriton House, Marton Road, Middlesbrough
Cleveland
TS4 3BW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) | 1. Patient satisfaction score (0-100mm line) 2. Paraesthesia coverage (0-100mm line) 3. Global perceived effect (1-7) |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 31/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
South Tees Hospitals NHS Trust
Cleveland
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
