ong-term outcome of intrathecal opiod therapy for non-malignant pain syndrome

• Conditions: Chronic intractable pain; F45.41; R52.1

• Registration Number: DRKS00017499
• Lead Sponsor: Abteilung für Neurochirurgie

Brief Summary

Our data underlines the long-term efficiacy of intrathecal pump therapy in patients with refractory non-malignant pain syndrome. Even after multiple pump exchanges and despite drug side-effects or pump-related complications, patient satisfaction remains high. Intrathecal drug doses seem to reach a steady-state after 3 years of therapy. Multidimensional pain assessment showed pain-related restrictions in physical activities with menial impact regarding mental and emotional stress in this patient cohort.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-06-14
• Study Start: 2019-07-02
• Results First Posted: 2019-10-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

1. Minimum age 18 years
2. drug-resistant chronic pain syndrome with a minimum duration of 1 year
3. non-malignant, not tumor-associated pain
4. All participants of this study have to be fully competent
5. Length of follow-up: minimum of 10 years after first implantation of pain pump

Exclusion Criteria

1. Subjects under arrest or in a lawsuit
2. Incompleteness of data
3. Inaccurate documentation of patient related data
4. Pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Endpoints: pain intensity score (visual analogue score, numeric rating scale), quality of life according to the German Pain Questionnaire

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints: long-term complications, risk, and side-effects of intrathecal pain therapy; revision surgery, drug related effects, infections, pump associated defects/malfunction, treatment costs, drug dose