The effects of social learning on the efficacy of a treatment with "open label" placebos in patients with chronic low back pain

The effects of social learning on the efficacy of a treatment with "open label" placebos in patients with chronic low back pain - SocLearn2

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00020416

Enrollment

Registered

2020-10-08

Start date

2020-10-15

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 F45.41

Interventions

Group 1: 1. Treatment group “open label placebo – only instruction”: the placebo effect is explained to the participants and they are instructed how to take the placebo over the next 3 weeks. The para

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: chronic low back pain

Exclusion criteria

Exclusion criteria: Other chronic pain predominant non sufficient knowledge of language cannot consent major depressive disorder diagnosed fibromyalgia back pain induced by tumor cognitive impairment health status prohibits participation Galactosemia Lack of lactase glucose-Galactose-malabsorbtion chronic diseases with a dominant role on disability (e.g., rheumatic disorders, cancer, severe heart diseases) pain-relevant “red flags” (Koes et al., 2010) inflammatory or neuropathic back pain severe acute or chronic mental disorders (such as psychosis) pregnancy and breastfeeding Koes BW, van Tulder M, Lin CW, Macedo LG, Mc Auley J, Maher C (2010) An updated overview of clinical guidelines for the management of non- specific low back pain in primary care. Eur Spine J 19(12):2075–94.

Design outcomes

Primary

Measure	Time frame
average pain on a numeric rating scale between 0 = no pain to 10 = strongest pain imaginable). Points of data collection: before the intervention, shortly after the intervention, 3 month after the intervention	—

Secondary

Measure	Time frame
functional capacity: Self rating (FFbH-R) external rating (see below) FFbH-R – Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbe-einträchtigung durch Rückenschmerzen: Kohlmann, T. (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Rehabilitation, 35, I-VIII. Expectancy: - Expected pain reduction after the intervention (on a numerical rating scale 0-100%); - expected reduction in pain events (scale: very often, often, moderately often, seldom, very seldom, never) - Expected reduction of duration of pain events (scale: very long, long, moderately long, short, very short, no occurence at all) data collection protocol for physical exercises: The physical exercises are based on the FFbH-R: Picking up a coin while standing, picking up a case of bottled water from the floor and puting it on a table, getting to a sitting position after laying down, removing your socks and putting them on again. Both the participant and the researcher rate the exercises on a scale from 0 - 3 in difficulty. The time is stopped and the the exercises are video taped for external blinded rating.	—

Measure

Time frame

functional capacity: Self rating (FFbH-R) external rating (see below) FFbH-R – Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbe-einträchtigung durch Rückenschmerzen: Kohlmann, T. (1996). Der Funktionsfragebogen Hannover zur alltagsnahen Diagnostik der Funktionsbeeinträchtigung durch Rückenschmerzen (FFbH-R). Rehabilitation, 35, I-VIII. Expectancy: - Expected pain reduction after the intervention (on a numerical rating scale 0-100%); - expected reduction in pain events (scale: very often, often, moderately often, seldom, very seldom, never) - Expected reduction of duration of pain events (scale: very long, long, moderately long, short, very short, no occurence at all) data collection protocol for physical exercises: The physical exercises are based on the FFbH-R: Picking up a coin while standing, picking up a case of bottled water from the floor and puting it on a table, getting to a sitting position after laying down, removing your socks and putting them on again. Both the participant and the researcher rate the exercises on a scale from 0 - 3 in difficulty. The time is stopped and the the exercises are video taped for external blinded rating.

—

Countries

Germany

Contacts

Public ContactRegine Klinger

Bereichs Schmerzmedizin und SchmerzpsychologieUniversitätsklinikum Hamburg-Eppendorf (UKE)?Zentrum für Anästhesiologie und Intensivmedizin?Klinik und Poliklinik für Anästhesiologie

r.klinger@uke.de040 7410 20130

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026