Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
02/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

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

N0557115188

Study information

Scientific title

Acronym

Study hypothesis

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

Added 07/04/10: Birmingham and Black Country Ethics Committee, Dudley Local Research Ethics Committee 23/2/2002, ref REC/35/02/Jun

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

diamorphine

Primary outcome measures

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 trial start date

01/01/2003

Overall trial end date

31/12/2010

Reason abandoned

Participant recruitment issue

Eligibility

Participant inclusion criteria

Added 07/04/10:
Intrathecal pump in situ patient at Russells Hall Hospital

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Aim to recruit 24 patients to the study.

Participant exclusion criteria

Added 07/04/10:
Patients failing to give consent

Recruitment start date

01/01/2003

Recruitment end date

31/12/2010

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 http://www.ncbi.nlm.nih.gov/pubmed/23903811

Publication citations

  1. Results

    Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD, Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain., BMJ Open, 2013, 3, 7, doi: 10.1136/bmjopen-2013-003061.

Additional files

Editorial Notes