Main
|
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: |
|
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.)
|
Source(s) of Monetary Support
|
Universität zu Lübeck
|
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
|
|