Bolus versus continuous study

Completed

• Conditions: Severe chronic pain; Signs and Symptoms; Chronic pain

• Registration Number: ISRCTN61628624
• Lead Sponsor: South Tees Hospitals NHS Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-29
• Last Update Posted: 18 December 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Patients implanted with a programmable intrathecal drug delivery (ITDD) device
2. Achieved stable pain relief on continuous flow
3. Capable of giving informed consent
4. Willing to sign the Informed Consent Form
5. Male or female, aged between 18 and 65 years

Exclusion Criteria

1. Fail to give informed consent
2. Are incapable of answering the questionnaires (PGIC, EuroQoL [EQ-5D], Visual Analogue Scale [VAS] score) for physical or psychological reasons
3. Have non-programmable ITDD device
4. Have Patient Therapy Manager (PTM) devices
5. Are using ziconotide intrathecal therapy
6. Are programmed with bolus doses (flex doses)
7. Have severe limitation in function and mobility
8. Are pregnant or lactating
9. Are not practicing a safe method of birth control

Study & Design

• Study Type: Interventional
• Study Design: Not specified