- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03942562
Temporal Relationship in Recovery of Muscular Pain and Functional Variables in an Experimental Muscular Pain Model in Hamstrings
Temporal Relationship in Recovery of Muscular Pain, Functional Variables and Normal Gait Pattern in an Experimental Muscular Pain Model in Hamstrings
Basal measurements are taken in relation to the study variables. Immediately subjects perform eccentric exercise on right hamstrings to develop delayed onset muscle soreness (DOMS).
Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.
Study Overview
Status
Conditions
Detailed Description
Basal measurements are taken in relation to the study variables.
The variables are:
- pressure pain thresholds
- electromyography values
- static and dynamic plantar pressure measurement
- active knee extensibility
- maximal strength of knee flexors
- thermography
- scales of pain perception
Immediately subjects perform eccentric exercise on right hamstrings to develop DOMS (delay onset muscle soreness).
Measurements of the study variables are taken in the same conditions 48, 96 and 168 hours after the exercise to study the evolution of the variables while recovering from DOMS.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Zaragoza
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Villanueva De Gállego, Zaragoza, Spain, 50830
- Universidad San Jorge
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- not sedentary subject (IPAQ scale > 600 MET)
- healthy subjects, without pain nor injury at the moment
Exclusion Criteria:
- subjects with acute or chronic pain on every spot of pelvis or lower limbs at the momento or for the last 3 months;
- subjects with history of severe injury in the hamstrings muscles;
- presence of serious illness;
- presence of pathologies in relation to chronic pain (as fibromyalgia, migraine disorders, non specific and chronic lumbar pain);
- not commitment for continuity in the study program;
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in spatio temporal parameters of gait
Time Frame: Baseline, 48 hours, 96 hours, 1 week
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Changes in spatio temporal parameters of gait over a treadmill will be measurement using an optical measurement system consisting of a transmitting and receiving bar (OptoGait System).
|
Baseline, 48 hours, 96 hours, 1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Pressure Pain Thresholds
Time Frame: Baseline, 48 hours, 96 hours, 1 week
|
Changes in pressure pain thresholds (PPT) will be determined with pressure algometry bilaterally over the leg and shoulder.
PPT is defined as the exact time point where the pressure is first being perceived at painful.
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Baseline, 48 hours, 96 hours, 1 week
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Changes in active knee extension test
Time Frame: Baseline, 48 hours, 96 hours, 1 week
|
Changes in range of motion (°; degrees) will be assessed in both sides using the active knee extension (AKE) test. AKE test: subject is lying prone with hip and knee flexed at 90°. Then, maximal knee extension is performed. |
Baseline, 48 hours, 96 hours, 1 week
|
Changes in knee-flexors maximal isometric muscle strength
Time Frame: Baseline, 48 hours, 96 hours, 1 week
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Changes in knee-flexors maximal isometric strength (Newton) will be assessed by using a hand-held dynamometer.
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Baseline, 48 hours, 96 hours, 1 week
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Electromyography (EMG) measurement during the tests
Time Frame: Baseline, 48 hours, 96 hours, 1 week
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Electromyography values will be taken from hamstrings during the performance of gait analysis and dynamometry
|
Baseline, 48 hours, 96 hours, 1 week
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Changes in thermography on hamstrings areas
Time Frame: Baseline, 48 hours, 96 hours, 1 week
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A thermography image will be taken every day of assessment.
Changes in colour pixels will be analysed to determine temperature changes.
|
Baseline, 48 hours, 96 hours, 1 week
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Changes in static and dynamic plantar pressure measurement
Time Frame: Baseline, 48 hours, 96 hours, 1 week
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Changes in static and dynamic plantar pressure measurement will be performed in every session by using a pressure platform.
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Baseline, 48 hours, 96 hours, 1 week
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Changes in subjective perception of pain and impairment: Two questionnaire (Modified 7-item Likert Scales)
Time Frame: 48 hours, 96 hours, 1 week
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Two questionnaires (Modified 7-item Likert Scales) are filled up by the subject to show subjective perception of pain related to movement along the recovery period. Scale of pain intensity, from 0 (no pain) to 6 (higher pain intensity). Scale of functional impairment, from 0 (no impairment) to 6 (higher impairment). |
48 hours, 96 hours, 1 week
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Víctor Doménech, MSc, Universidad San Jorge
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI18/208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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