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
Protocol serial number	N0557115189
Sponsor	Department of Health (UK)
Funder	The Dudley Group of Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised double-blind placebo-controlled crossover
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/04/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

Consultant in Pain Management

Dudley
DY1 4SE
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013		Yes	No