Bolus versus continuous study

Completed

• Conditions: Musculoskeletal diseases; Musculoskeletal Diseases

• Registration Number: ISRCTN21659064
• Lead Sponsor: South Tees Hospitals NHS Trust (UK)

Brief Summary

1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/27651513 (added 22/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-30
• Study Completion: 2012-09-01
• Last Update Posted: 11 February 2019

Recruitment & Eligibility

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

Inclusion Criteria

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
6. Aged between 18 years and 65 years of age

Exclusion Criteria

1. Fail to give informed consent
2. Are incapable of answering the questionnaires: PGIC, EQ5D, 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 practising a safe method of birth control

Study & Design

• Study Type: Interventional
• Study Design: Not specified