Endogenous pain modulation after intensive muscle exertion and during experimentally induced muscle pain: conditioned pain modulation and offset analgesia
Organizational Data
- DRKS-ID:
- DRKS00014755
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-05-15
- Last update in DRKS:
- 2019-10-31
- Registration type:
- Prospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
Studies in patients with chronic pain have shown that persistent pain leads to a change in the perception of painful and non-painful stimuli. The reason seems to be that people with chronic pain are no longer able to differentiate stimuli, i.e. perceive them differently depending on their intensity. There is occasional evidence that these mechanisms also occur in acute pain. We do not know yet whether this change in perception can be brought through benign muscle pain. In the current study the effect of a muscle exertion and a possibly resulting benign muscle pain ("muscle soreness") on various perception tests is to be examined.
Brief summary in scientific language
The lack of ability to perceive stimuli in a differentiated way, i.e. limited endogenous pain modulation, seems to be one of the main mechanisms for persistent pain syndromes or a possible explanation for the chronification of pain. It has not yet been clarified whether an altered pain modulation also occurs with acute pain, especially with benign muscle pain. Furthermore, it is known that pain modulation can be influenced, but it is not finally clarified whether changes can already be measured after a muscle exertion. The study will therefore investigate in healthy individuals whether measurable changes in pain modulations can be measured after a short training stimulus and whether these changes are influenced by the occurrence of benign muscle pain ("muscle soreness").
Health condition or problem studied
- Free text:
- Pain-free young adults
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
- Arm 2:
- no intervention
Endpoints
- Primary outcome:
- 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:
- 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.)
Study Design
- Purpose:
- Basic research/physiological study
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Investigator/therapist
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Poland
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Institut für Systemische Neurowissenschaften Hamburg
- University medical center Klinik für Orthopädie und Unfallchirurgie Lübeck
- University medical center The Jerzy Kukuczka Academy of Physical Education in Katowice Katowice
Recruitment period and number of participants
- Planned study start date:
- 2018-06-01
- Actual study start date:
- 2018-06-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2018-09-03
- Target Sample Size:
- 42
- Final Sample Size:
- 42
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 45 Years
- Additional 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)
Addresses
Primary Sponsor
- Address:
- Universität zu LübeckProf. Dr. Kerstin LuedtkeRatzeburger Allee 16023562 LübeckGermany
- Telephone:
- Tel + 49 451 3101 8541
- Fax:
- Fax + 49 451 3101 8544
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-luebeck.de/
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universität zu LübeckM.Sc. Tibor SzikszayRatzeburger Allee 16023562 LübeckGermany
- Telephone:
- Tel + 49 451 3101 8541
- Fax:
- Fax + 49 451 3101 8544
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-luebeck.de
Contact for Public Queries
- Address:
- Universität zu LübeckM.Sc. Tibor SzikszayRatzeburger Allee 16023562 LübeckGermany
- Telephone:
- Tel + 49 451 3101 8541
- Fax:
- Fax + 49 451 3101 8544
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-luebeck.de
Principal Investigator
- Address:
- Universität zu LübeckM.Sc. Tibor SzikszayRatzeburger Allee 16023562 LübeckGermany
- Telephone:
- Tel + 49 451 3101 8541
- Fax:
- Fax + 49 451 3101 8544
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-luebeck.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universität zu LübeckRatzeburger Allee 16023562 LübeckGermany
- Telephone:
- Tel + 49 451 3101 8541
- Fax:
- Fax + 49 451 3101 8544
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uni-luebeck.de/
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Med. Fakultät der Universität zu LübeckRatzeburger Allee 16023538 LübeckGermany
- Telephone:
- +49-451-5004639
- Fax:
- +49-451-5003026
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2017-12-22
- Ethics committee number:
- 18-006
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2018-02-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry