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
- 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
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
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
Name Time Method 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
Name Time Method - Patient-relevant aspects regarding pain-related impairment of activities of daily life <br><br>- Overall quality of life