Pain Clinical Trial
Official title:
Pilot Study of Quality Assurance in Interventional Pain Therapy in the Lumbal Spinal Column. Non-randomised, Evaluative, Multicentral Study Concerning the Applicability of a Tablet-PC.
There are actually no standardized quality assurance procedures included in pain treatment
processes.
In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested
in pain therapy centres using the validated questionnaire "Activity Index". The acceptance
of electronic data capturing is tested in patients and therapy teams (doctors and nurses).
Regarding the demand for a duly documented efficacy of the therapy applied, a standardized
procedure is imperative to show the medical and economic advantages of a given therapy. To
obtain valid results, it is necessary to use a standardized process, monitored with a
validated questionnaire.
In this multi-center study the Activity Index Questionnaire will be tested regarding its
outcome quality regarding usability and patient acceptance. Each center collects data of 10
patients with injection pain therapy. Each patient is interviewed twice and after the 2nd
interview each patient will fill out a feasibility questionnaire. During the whole study,
the use and consumption of oral analgetic drugs are monitored in a diary. The statistical
Analysis is done descriptive. Before entering the study, each patient has to give informed
consent to participate. National Registration Guidelines for post market surveillance will
be obtained.
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Observational Model: Cohort, Time Perspective: Prospective
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