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ISRCTN
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ISRCTN45019882
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ClinicalTrials.gov identifier
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Public title
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Randomised double-blind placebo-controlled crossover trial of diamorphine by implantable drug delivery system in the treatment of chronic non-malignant pain
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0557115189
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Study hypothesis
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Do implanted intrathecal analgesic drug pumps relieve pain in patients with chronic non-malignant pain?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double-blind placebo-controlled crossover
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Signs and Symptoms: Pain
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2002
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Anticipated end date
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30/04/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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16
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Interventions
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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).
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The Dudley Group of Hospitals NHS Trust (UK)
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Trial website
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Publications
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Contact name
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Dr
Jonathan
Raphael
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Address
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Consultant in Pain Management
Guest Hospital
Tipton Road
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City/town
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Dudley
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Zip/Postcode
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DY1 4SE
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Country
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United Kingdom
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Tel
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+44 (0)1384 244809
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Fax
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+44 (0)1384 244808
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Email
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JH.Raphael@dgoh.nhs.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)207 307 2622
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Fax
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+44 (0)207 307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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05/05/2010
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Date ISRCTN assigned
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12/09/2003
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