Severe chronic pain Signs and Symptoms Chronic pain
Conditions
Interventions
Non-clinical interventions:
1. Informed consent will be obtained by the Principal Investigator, from the patient prior to enrolment of patient into the study. This will occur only once and will take a
Sponsors
South Tees Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient Global Impression of Change (PGIC), a self-evaluation of the patient's overall change since the start of the study, will be completed at the end of each 2 week period using a 7-point Likert scale (very much improved, much improved, minimally improved, no change, minimally worse, much worse, very much worse). The PGIC was chosen as it will allow the patient to balance a potential improvement in pain relief with a potential worsening in side effects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Conducted at baseline and the end of each 2-week period: 1. Visual Analogue Scale (VAS) of pain relief patients will score their pain on a 100 mm line anchored with 'no pain' at the 0 mm end and 'worst pain imaginable' at the 100 mm end 2. EQ-5D is a health related quality of life questionnaire which is divided into five dimensions: mobility, self-care, usual activity, pain/discomfort and anxiety/depression 3. Patient preference - at the end of the study, patients will be asked to choose which of the two programming methods they prefer 4. Observer guess of the group - to discover how successful the blinding is, the blinded assessor and the patient will be asked if they can identify which programming method has been allocated. If neither can identify the method, this will show the blinding has been successful, and refute any claims of bias. | — |
Countries
Switzerland, United Kingdom
Outcome results
None listed