Localized unspecific pain of the upper or lower back
Conditions
Interventions
Group 1: Single arm, multicentre, open-label post-marketing follow-up observational study to evaluate the efficacy/tolerability of the Philips BlueTouch Pain Relief Patch in the daily routine treatmen
Sponsors
Philips Consumer Lifestyle
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patient age =18 years Patient is able and willing to understand a written informed consent Patient suffers from back pain Patient is able to comply with the study characteristics and to fulfill its requirements, according to the investigator's evaluation
Exclusion criteria
Exclusion criteria: Patient is currently or was within the previous 4 weeks enrolled in an interventional clinical trial Patient is actually suffering from conditions and illnesses that might interfere with the trial purpose, according to the investigator's evaluation Patient has a history of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) that could limit the subject's ability to comply with trial procedures Patient has insufficient knowledge of the German language to understand the Informed Consent Form and/or trial questionnaires Patient is/was involved in the planning and conduct of the trial (applies to either Philips staff, staff participating at the trial site or staff of the logistics CRO) Patient suffers from any condition or illness as listed in the contraindications section of the BlueTouch Pain Relief Patch user manual Patient has used the Philips BlueTouch Pain Relief Patch before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome on efficacy and tolerability: Queries based on two "verbal rating scales" in the physician's interim documentation (after 1 week of therapy) as well as in the physician's end documentation (after 2 weeks of therapy) compared to the previous non-drug or drug treatments. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Patient-relevant aspects regarding pain-related impairment of activities of daily life - Overall quality of life | — |
Countries
Germany
Contacts
Public ContactGerhard H.H. Müller-Schwefe
Schmerz- und Palliativzentrum Göppingen Deutsche Gessellschaft für Schmerztherapie e.V.
Outcome results
None listed