Open Label Placebo Treatment in Chronic Backpain: The Impact on Pain and Mobility
Not Applicable
- Conditions
- M54Dorsalgia
- Registration Number
- DRKS00012712
- Lead Sponsor
- niversitätsklinikum EssenKlinik für Neurologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 127
Inclusion Criteria
Age> 18 years, persistent back pain of the same quality for more than 12 weeks, diagnosis ensured by a specialist, voluntarily, informed consent to study participation
Exclusion Criteria
Any history of malignancy in the past 5 years, any severe and regarding the study objectives highly influential diagnosis due to the investigator’s opinion, neurological deficits (e.g. paralysis, any severe psychological disorder (e.g. major depressive disorder, personality disorder, psychosis); Clinically not significant pain during the prior week before Baseline (referred to as a rating less than 4 on an 11-point numerical rating scale (0-10; no pain”, worst pain”).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the change of the subjective pain intensity on a numeric rating scale, calculated as delta NRS composite score (average of mean, minimum and maximum) of day 21 and baseline (day 0).
- Secondary Outcome Measures
Name Time Method The following secondary outcomes are assessed: Change in range of lumbar spinal Motion (RoM) and Velocity of lumbar Motion (VoM) as assessed with the Epionics Spine System (Epionics SPINE, Epionics GmbH, Hamburg, Germany). Oswestry disability questionnaire for low back pain (ODI), Patient specific functional scale (PSFS) and Back performance scale (BPS) are obtained to assess changes in different aspects of physical functioning at the objective and subjective level, respectively. Further, levels of depression, anxiety and stress (DASS) are obtained to assess changes in emotional well-being. As exploratory measures individual expectancy levels (CEQ) and post-hoc treatment efficacy ratings are recorded.