Randomised double-blind placebo-controlled crossover trial of diamorphine by implantable drug delivery system in the treatment of chronic non-malignant pain
| ISRCTN | ISRCTN45019882 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45019882 |
| Secondary identifying numbers | N0557115189 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 26/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jonathan Raphael
Scientific
Scientific
Consultant in Pain Management
Guest Hospital
Tipton Road
Dudley
DY1 4SE
United Kingdom
| Phone | +44 (0)1384 244809 |
|---|---|
| JH.Raphael@dgoh.nhs.uk |
Study information
| Study design | Randomised double-blind placebo-controlled crossover |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Do implanted intrathecal analgesic drug pumps relieve pain in patients with chronic non-malignant pain? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | 1. Pump filled with diamorphine in normal saline set initially to deliver 0.5 ml/day (0.1 ml) 2. Pump filled with normal saline and set initially to deliver 0.1 ml per day For the first 2 weeks the pump can be increased by 0.05 ml/day at half-weekly reviews if the patient describes inadequate pain relief. The pump rate will remain constant for the next 4 weeks and be returned to 0.1 ml/day by week 8 (in half-weekly intervals by increments of 0.05 ml/day). The pump is then refilled with the alternative mixture and the process repeated, ending with 0.1 ml/day by week 8 of the second pump refill (week 16). |
| Intervention type | Other |
| Primary outcome measure | 1. Pain relief by Visual Analogue Scale (VAS) 2. Function by Oswestry Disability Score 3. Psychological parameters by Hospital Anxiety Depression Score 4. Pain Coping Strategies Questionnaire 5. Sociological factors by Short Form-36 Questionnaire 6. Overall Assessment by Global Impression of Change |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2002 |
| Completion date | 30/04/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 16 |
| Key inclusion criteria | Aim to recruit 16 patients to the trial from patients scheduled for intrathecal pump implantation for the delivery of diamorphine in the management of chronic non-cancer pain. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 30/04/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Consultant in Pain Management
Dudley
DY1 4SE
United Kingdom
DY1 4SE
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
The Dudley Group of 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No |
