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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.
Register: German Clinical Trials Register
Last refreshed on: 8 April 2024
Main ID:  DRKS00014755
Date of registration: 15/05/2018
Prospective Registration: Yes
Primary sponsor: Universität zu Lübeck
Public title: Endogenous pain modulation after intensive muscle exertion and during experimentally induced muscle pain: conditioned pain modulation and offset analgesia
Scientific title: Endogenous pain modulation after intensive muscle exertion and during experimentally induced muscle pain: conditioned pain modulation and offset analgesia
Date of first enrolment: 01/06/2018
Target sample size: 42
Recruitment status: Complete
URL:  http://drks.de/search/en/trial/DRKS00014755
Study type:  interventional
Study design:  Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: No treatment / Standard of care; Assignment: parallel; Study design purpose: basic science  
Phase:  N/A
Countries of recruitment
Germany Poland
Contacts
Name: Tibor    Szikszay
Address:  Ratzeburger Allee 160 23562 Lübeck Germany
Telephone: Tel + 49 451 3101 8541
Email: tibor.szikszay@uni-luebeck.de
Affiliation:  Universität zu Lübeck
Name: Tibor    Szikszay
Address:  Ratzeburger Allee 160 23562 Lübeck Germany
Telephone: Tel + 49 451 3101 8541
Email: tibor.szikszay@uni-luebeck.de
Affiliation:  Universität zu Lübeck
Key inclusion & exclusion criteria
Inclusion criteria: healthy (pain free) male or female
Age: 18-45 years

Exclusion criteria: chronic pain disorder, acute pain (including headache, toothache, muscle ache, etc.), orthopaedic or other diagnosis that does not allow to perform a training stimulus, Pregnancy, neurological, psychiatric or psychological illness
migraine (if more than 1-2 attacks per year)


Age minimum: 18 Years
Age maximum: 45 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pain-free young adults
Intervention(s)
Group 1: One-time isometric muscle load for the back extensor muscle (max. 4 minutes Biering-Sörensen test followed by concentric/eccentric muscle load for the back extensor (individual maximum number of repetitions)).

The test is guided by a specialist physiotherapist who is not otherwise involved in the study.


Group 2: no intervention
Primary Outcome(s)
Offset analgesia (thermode):

4 repeated measurements:
Before the muscle load (1.), immediately afterwards (2.), 24 hours later (3.) and one week later (4.)
Secondary Outcome(s)
Conditioned pain modulation (test stimulus: pressure pain thresholds; conditioning stimulus: ice water); Exercise-induced hypoalgesia (pressure pain threshold)

4 repeated measurements:
Before the muscle load (1.), immediately afterwards (2.), 24 hours later (3.) and one week later (4.)
Secondary ID(s)
Source(s) of Monetary Support
Universität zu Lübeck
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 01/02/2018
Contact:
ethikkommission@uni-luebeck.de
Ethik-Kommission der Med. Fakultät der Universität zu Lübeck
+49-451-5004639
ethikkommission@uni-luebeck.de
Results
Results available:
Date Posted:
Date Completed: 03/09/2018
URL: http://drks.de/search/en/trial/DRKS00014755#studyResults
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