Placebo Effects of a Sham Opioid Solution: A Randomized Controlled Study in Patients with Chronic Low Back Pain

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00011201

Enrollment

Registered

2016-12-29

Start date

2004-10-04

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: NaCL-solution with instruction "opioid-solution", 2 x 10 Min. Group 2: NaCL-solution with instruction "placebo-solution", 2 x 10 Min.

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: chronic back pain, diagnoses: chronic unspecific, non radicular back pain;

Exclusion criteria

Exclusion criteria: Acute radicular pain; inflammatory or tumor related pain; current pain reduction due to any injection; neurological deficit pathology; severe cognitive disability or cognitive disability due to medication; mental disorders in terms of ICD10 (exception: F45.41 or depressive disorder due to pain); insufficent knowledge of the German language; heart disease.

Design outcomes

Primary

Measure	Time frame
Numerical rating scale NRS 0-10 (0=no back pain, 10= worst pain); Measurement time points: 1) pre 1st exercise; 2) post 1st exercise; 3) pre 1st solution 4) post 1st solution – conditoning; 5)pre 2nd exercise; 6) post 2nd exercise; 7) pre 2nd solution; 8) post 2nd solution;	—

Secondary

Measure	Time frame
A) Acute experimental pain: pain rating 0-10; B) functional capacity: 1.) 12-item scoring system (Hannover Activities of Daily Living questionnaire [ADL]); 2. measured time the patients needed to perform their exercise; C) expectation: 6-point verbal rating scale ranging from 1= no pain reduction to 6=pain free. Measurement time points: A) Acute experimental pain: 1) Baseline, 2) pre 1st. solution, 3) post 1. Lösung/Konditionierung, 4) post 1. Lösung – nach Konditionierung, 5) prä 2. Lösung, 6) post 2. Lösung; B) functional capacity: 1) pre 1st. solution 2) post 1st. solution; C) expectation: 1) pre 1st. solution, 2) post 1st. solution, 3) post 2st. solution;	—

Measure

Time frame

A) Acute experimental pain: pain rating 0-10; B) functional capacity: 1.) 12-item scoring system (Hannover Activities of Daily Living questionnaire [ADL]); 2. measured time the patients needed to perform their exercise; C) expectation: 6-point verbal rating scale ranging from 1= no pain reduction to 6=pain free. Measurement time points: A) Acute experimental pain: 1) Baseline, 2) pre 1st. solution, 3) post 1. Lösung/Konditionierung, 4) post 1. Lösung – nach Konditionierung, 5) prä 2. Lösung, 6) post 2. Lösung; B) functional capacity: 1) pre 1st. solution 2) post 1st. solution; C) expectation: 1) pre 1st. solution, 2) post 1st. solution, 3) post 2st. solution;

—

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 741052837

Outcome results

None listed

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