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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00011230 |
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Date of registration:
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29/11/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Placebo analgesia and social learning: Is it possible to increase medication effect via processes of social learning?
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Scientific title:
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Placebo analgesia and social learning: Is it possible to increase medication effect via processes of social learning? |
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Date of first enrolment:
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29/11/2016 |
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Target sample size:
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44 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00011230 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Regine
Klinger |
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Address:
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Martinistr. 52
20246
Hamburg
Germany |
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Telephone:
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0049 40 7410 52837 ?Mobil: 0049 152 22824387 |
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Email:
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r.klinger@uke.de |
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Affiliation:
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Universitätsklinikum Hamburg-Eppendorf (UKE)?Zentrum für Anästhesiologie und Intensivmedizin?Klinik und Poliklinik für AnästhesiologieBereichs Schmerzmedizin und Schmerzpsychologie? |
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Name:
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Regine
Klinger |
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Address:
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Martinistr. 52
20246
Hamburg
Germany |
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Telephone:
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0049 40 7410 52837 ?Mobil: 0049 152 22824387 |
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Email:
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r.klinger@uke.de |
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Affiliation:
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Universitätsklinikum Hamburg-Eppendorf (UKE)?Zentrum für Anästhesiologie und Intensivmedizin?Klinik und Poliklinik für AnästhesiologieBereichs Schmerzmedizin und Schmerzpsychologie? |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with chronic back pain, ongoing treatment in the pain center of the UKE, ongoing medication: Amitriptyline.
Exclusion criteria: Exclusion criteria: acute or chronic mentally disorders excluding: F45.41 (nach ICD-10; DSM-IV bzw. DSM-V), insufficient knowledge of German language or eye-sight, cognitive impairment or intake of medication, which impairs consciousness.
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dorsalgia
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M54
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Intervention(s)
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Group 1: Intervention group: Positive information about the medication (Amitriptilyn, individual dosage)-- Patients will be randomized and allocated to the intervention group. A social observational Situation will be arranged: An alleged patient will tell the subject (patient) positive information about the subscribed medication (Amitriptilyn, individual dosage). The alleged patient will tell the subject, that he received the same medication like the subject, that he feels very good with the medication, has a high pain reduction.
Group 2: Control group: neutral information about the medication (Amitriptilyn, individual dosage)--
Patients will be randomized and allocated to the control group. A social observational Situation will be arranged: An alleged patient will tell the subject (patient) positive information about the subscribed medication (Amitriptilyn, individual dosage). The alleged patient will tell the subject, that he received the same medication like the subject.
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Primary Outcome(s)
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Pain rating: Numerical Rating Scale (NRS) 0-10, Pre-, Post-, 2 weeks follow up
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Secondary Outcome(s)
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pain associated variables:
Pain Disability, functional capacity, depressive mood, pain catastrophizing, quality of life
Pre, post, 2 weeks follow up (concerning experimental social learning situation)
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Secondary ID(s)
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U1111-1190-1835
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Source(s) of Monetary Support
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Deutsche Forschungsgemeinschaft
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Universitätsklinikum Hamburg-Eppendorf (UKE)?Zentrum für Anästhesiologie und Intensivmedizin?Klinik und Poliklinik für AnästhesiologieBereichs Schmerzmedizin und Schmerzpsychologie?
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Ethics review
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Status: Approved
Approval date: 02/11/2016
Contact:
filipp@uni-trier.de
Ethikkommission der Deutschen Gesellschaft für Psychologie e.V. (DGPs) [Prof. Dr. Sigrun-Heide Filipp
Ethikkommission der Deutschen Gesellschaft für Psychologie (DGPs), DGPsychologie - Universität Trier - D-54286 Trier]
+49 30 28047718
filipp@uni-trier.de
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