- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03886883
Endogenous Modulation of Pain and Stretch Tolerance
March 22, 2019 updated by: University College of Northern Denmark
Endogenous Modulation of Pain - the Tolerance to Stretch
This study investigates the role of two endogenous inhibitory mechanisms; exercise-induced hypoalgesia (EIH) and a conditioning painful stimulus (CPM) on passive joint range of motion, passive resistive torque and pain sensitivity.
The study is a randomized, repeated-measures cross-over study.
Study Overview
Status
Completed
Conditions
Detailed Description
The increase in range of motion following stretching is related to changes in the tolerance to stretch.
The mechanistic relationships behind these changes in subject sensation are however unknown but could be related to endogenous modulation of pain.
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aalborg, Denmark, 9220
- University College of Northern Denmark
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Eligibility for participation included the absence of any pain or other conditions that might affect the somatosensory system.
Exclusion Criteria:
- Substance abuse, History of neurological or mental disabilities, Lack of ability to comply with instructions, Delayed onset of muscle soreness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise-induced hypoalgesia (EIH)
Exercise-induced hypoalgesia - isometric muscle contractions of the hand flexors
|
An EIH response was induced by a 3-minute isometric contraction of the hand flexor muscles at 25% of maximal voluntary contraction (MVC).
|
|
Active Comparator: Static stretch (SS)
A static stretch of the knee flexors
|
Two bouts of 30 seconds of static stretching (SS) of the knee flexors.
|
|
Sham Comparator: Rest
No intervention
|
The participants rested in a seated position for 10 minutes
|
|
Experimental: Conditioning painful stimulus (CPM)
Conditioned pain modulation - cold pressure test
|
A CPM response was induced by way of the cold pressor test.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee extension range of motion
Time Frame: Passive knee extension range of motion was measured as a baseline just prior to the induction of exercise-induced hypoalgesia (EIH), Static stretch (SS), Rest and a conditioning painful stimulus (CPM)
|
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
|
Passive knee extension range of motion was measured as a baseline just prior to the induction of exercise-induced hypoalgesia (EIH), Static stretch (SS), Rest and a conditioning painful stimulus (CPM)
|
|
Knee extension range of motion
Time Frame: Passive knee extension range of motion was measured 30 seconds after the induction of EIH, SS, Rest and CPM
|
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
|
Passive knee extension range of motion was measured 30 seconds after the induction of EIH, SS, Rest and CPM
|
|
Knee extension range of motion
Time Frame: Passive knee extension range of motion was measured 10 minutes after the induction of EIH, SS, Rest and CPM
|
Passively induced knee extension range of motion was measured using the Biodex system 4 pro isokinetic dynamometer
|
Passive knee extension range of motion was measured 10 minutes after the induction of EIH, SS, Rest and CPM
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Passive resistive torque
Time Frame: Passive resistive torque was measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
|
Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
|
Passive resistive torque was measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
|
|
Passive resistive torque
Time Frame: Passive resistive torque was measured 30 seconds after the induction of EIH, SS, Rest and CPM
|
Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
|
Passive resistive torque was measured 30 seconds after the induction of EIH, SS, Rest and CPM
|
|
Passive resistive torque
Time Frame: Passive resistive torque was measured 10 minutes after the induction of EIH, SS, Rest and CPM
|
Passive resistive torque during the passive knee extension motion was measured using the Biodex system 4 pro isokinetic dynamometer.
|
Passive resistive torque was measured 10 minutes after the induction of EIH, SS, Rest and CPM
|
|
Pressure pain thresholds
Time Frame: Pressure pain thresholds were measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
|
Pressure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
|
Pressure pain thresholds were measured as a baseline just prior to the induction of EIH, SS, Rest and CPM
|
|
Pressure pain thresholds
Time Frame: Pressure pain thresholds were measured 30 seconds after the induction of EIH, SS, Rest and CPM
|
Pressure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
|
Pressure pain thresholds were measured 30 seconds after the induction of EIH, SS, Rest and CPM
|
|
Pressure pain thresholds
Time Frame: Pressure pain thresholds were measured 10 minutes after the induction of EIH, SS, Rest and CPM
|
PRessure pain thresholds was measures using a handheld pressure algometer (Somedic AB, Hörby, Sweden.
|
Pressure pain thresholds were measured 10 minutes after the induction of EIH, SS, Rest and CPM
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Dorte Drachman, Msc., University College of Northern Denmark, Department of Physiotherapy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
December 30, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
March 20, 2019
First Posted (Actual)
March 22, 2019
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 22, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- UniversityCND1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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