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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 treatment of back pai

Recruiting
Conditions
ocalized unspecific pain of the upper or lower back
Registration Number
DRKS00005707
Lead Sponsor
Philips Consumer Lifestyle
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
1000
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

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

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome on efficacy and tolerability:<br>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 Outcome Measures
NameTimeMethod
- Patient-relevant aspects regarding pain-related impairment of activities of daily life <br><br>- Overall quality of life
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