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ISRCTN
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ISRCTN33733462
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of intrathecal diamorphine 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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N0557115188
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Study hypothesis
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1. Are intrathecal opioids useful in the treatment of severe chronic non-malignant pain?
2. Is therapeutic efficacy dose dependent?
3. Is gradual reduction of intrathecal opioid dose safe?
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Lay summary
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Not provided at time of registration
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Ethics approval
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Added 07/04/10: Birmingham and Black Country Ethics Committee, Dudley Local Research Ethics Committee 23/2/2002, ref REC/35/02/Jun
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Study design
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Randomised controlled trial
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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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Added 07/04/10:
Intrathecal pump in situ patient at Russells Hall Hospital
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Participants - exclusion criteria
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Added 07/04/10:
Patients failing to give consent
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Anticipated start date
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01/01/2003
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Anticipated end date
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31/12/2010
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Status of trial
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Stopped |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Aim to recruit 24 patients to the study.
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Interventions
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1. Dose of diamorphine reduced every week by 20% of the preceding week's dose for 10 weeks
2. No change in dose of diamorphine for 10 weeks
Patient is blinded to the changes made by computer telemetry.
As of 04/10/2011 this trial has stopped due to an increasing number of patients leaving the study.
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Primary outcome measure(s)
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1. Analgesic consumption
2. Pain level measured using Visual Analogue Score (VAS)
3. Function measured by Oswestry Disability Score (ODS)
4. Psychological parameters measured by Hospital Anxiety & Depression Score (HAD) and 5. Pain Coping Strategies Questionnaire (PCSQ)
6. Sociological parameters measured by SF-36
7. Overall assessment of change measured by Global Impression of Change (GIC)
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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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04/10/2011
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Date ISRCTN assigned
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12/09/2003
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