Randomised double-blind placebo-controlled crossover trial of diamorphine by implantable drug delivery system in the treatment of chronic non-malignant pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN45019882

Enrollment

Registered

2003-09-12

Start date

2002-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Signs and Symptoms: Pain Signs and Symptoms Pain

Interventions

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

Eligibility

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026