Open Label Placebo Treatment in Chronic Backpain: The Impact on Pain and Mobility

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00012712

Enrollment

150

Registered

2017-07-12

Start date

2017-03-27

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M54

Interventions

Group 1: Open-Label-Placebo application for 3 weeks (2 capsules per day) in addition to the individually established drug pain therapy. Group 2: 3-week observational period and continuation of individ

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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”).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Germany

Contacts

Public ContactJulian Kleine-Borgmann

Universitätsklinikum EssenKlinik für Neurologie

julian.kleine-borgmann@uk-essen.de00492017232446

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 20, 2026