M54
Conditions
Interventions
Group 1: As a part of the parental trial: Additional 3-week open-label placebo administration in addition to the treatment as usual
Group 2: As part of the parental trial: Treatment as usual only
Sponsors
Universitätsklinikum Essen Klinik für Neurologie
Eligibility
Sex/Gender
All
Age
18 Years to 95 Years
Inclusion criteria
Inclusion criteria: All patients, who were enrolled in the parental trial (Kleine-Borgmann et al., 2019) and are voluntarily willing to contribute to the follow-up trial.
Exclusion criteria
Exclusion criteria: Patients unwilling to contribute.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain intensity, assessed by the composite pain intensity score (mean of minimum, maximum, and average pain intensity during the last 4 weeks on an 11-point NRS [0-10, anchors: “no pain at all”–“unbearable pain”], see Kleine-Borgmann et al. (2019)) from baseline of parent trial (referred to as “baseline”) to 3 years after day 21 ± 3 months (referred to as “follow-up”). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in subjective functional disability from baseline to follow-up, assessed by the Oswestry Disability Index (Fairbank & Pynsent, 2000). 2) Change in anxiety, stress and depression scores from baseline to follow-up, assessed by the Depression Anxiety Stress Scales (Lovibond & Lovibond, 1995). For exploratory outcomes see study protocol attached. | — |
Countries
Germany
Contacts
Public ContactJulian Kleine-Borgmann
Universitätsklinikum Essen Klinik für Neurologie
Outcome results
None listed