Quality Assurance of Electronic Data Capturing (EDC) in Pain Treatment

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02256202

Enrollment

Registered

2014-10-03

Start date

2014-08-31

Completion date

2015-10-31

Last updated

2015-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Brief summary

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).

Detailed description

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.

Interventions

OTHERInterview

Monitoring interviews to show medical and economic advantages of given therapy

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Willingness for therapeutic pain injection in lumbar spine

Exclusion criteria

* Cognitive impairment, technical Problems in interviewing patients

Design outcomes

Primary

Measure	Time frame	Description
Feasibility of Tablet-PC in interviewing pain patients	6-12 months	The feasibility of the Tablet-PC in EDC will be assessed by standardized interviews (three times) of the study doctor, the study nurse and the patient.

Secondary

Measure	Time frame	Description
Problems in application of EDC in Tablet-PC	12 months	We measure the Problems of the Application of the EDC, e.g. Patient can't ush the button to answer the questions, e.g. some patients do not understand a question. The answers are usually given by Likert scales.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026