Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jonathan Raphael

ORCID ID

Contact details

Consultant in Pain Management
Guest Hospital
Tipton Road
Dudley
DY1 4SE
United Kingdom
+44 (0)1384 244809
JH.Raphael@dgoh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0557115189

Study information

Scientific title

Acronym

Study hypothesis

Do implanted intrathecal analgesic drug pumps relieve pain in patients with chronic non-malignant pain?

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind placebo-controlled crossover

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/09/2002

Overall trial end date

30/04/2004

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

16

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2002

Recruitment end date

30/04/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant in Pain Management
Dudley
DY1 4SE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

The Dudley Group of Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in
Raphael JH, Duarte RV, Southall JL, et al. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open 2013;3:e003061. doi:10.1136/bmjopen-2013-003061

Publication citations

Additional files

Editorial Notes