Comparison of the Effects of Intermittent Boluses to Simple Continuous Infusion on Patient Global Perceived Effect in Intrathecal Therapy for Pain. - Bolus versus Continuous Study

• Conditions: Severe, chronic pain in patients who require intrathecal analgesia; MedDRA version: 12.1Level: LLTClassification code 10049475Term: Chronic Pain

• Registration Number: EUCTR2010-020087-38-GB
• Lead Sponsor: South Tees Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Participants who :
1. Are implanted with a programmable Intrathecal Therapy Drug Device (ITDD)
2. Have achieved stable pain relief on continuous flow.
3. Are capable of giving informed consent.
4. Are willing to sign the Informed Consent form
5. Are male or female and aged between 18yrs and 65yrs of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Participants who:
1. Fail to give informed consent
2. Are incapable of answering the questionnaires; PGIC,EQ-5D, VAS Score for physical or psychological reasons
3. Have non-Programmable Device ITDD
4. Have Patient Therapy Manager devices (PTM's)
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 clinical trial of medicinal product
• Study Design: Not specified