Randomised controlled trial of intrathecal diamorphine in the treatment of chronic non-malignant pain

ISRCTN	ISRCTN33733462
DOI	https://doi.org/10.1186/ISRCTN33733462
Secondary identifying numbers	N0557115188

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 02/08/2013

Recruitment status: Stopped
Overall study status: Stopped
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 Jonathan Raphael
Scientific

Consultant in Pain Management
Guest Hospital
Tipton Road
Dudley
DY1 4SE
United Kingdom

Phone	+44 (0)1384 244809
Email	JH.Raphael@dgoh.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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?
Ethics approval(s)	Added 07/04/10: Birmingham and Black Country Ethics Committee, Dudley Local Research Ethics Committee 23/2/2002, ref REC/35/02/Jun
Health condition(s) or problem(s) studied	Signs and Symptoms: Pain
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	diamorphine
Primary outcome measure	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)
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2003
Completion date	31/12/2010
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Aim to recruit 24 patients to the study.
Key inclusion criteria	Added 07/04/10: Intrathecal pump in situ patient at Russells Hall Hospital
Key exclusion criteria	Added 07/04/10: Patients failing to give consent
Date of first enrolment	01/01/2003
Date of final enrolment	31/12/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Consultant in Pain Management

Dudley
DY1 4SE
United Kingdom

Sponsor information

Department of Health (UK)
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	31/07/2013		Yes	No