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Temporal Relationship in Recovery of Muscular Pain and Functional Variables in an Experimental Muscular Pain Model in Hamstrings

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ClinicalTrials.gov Identifier: NCT03942562
Recruitment Status : Completed
First Posted : May 8, 2019
Last Update Posted : November 10, 2020
Sponsor:
Information provided by (Responsible Party):
Universidad San Jorge

Study Description
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Brief Summary:

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.


Condition or disease
Pain, Muscle

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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Days
Official Title: Temporal Relationship in Recovery of Muscular Pain, Functional Variables and Normal Gait Pattern in an Experimental Muscular Pain Model in Hamstrings
Actual Study Start Date : October 15, 2018
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Changes in spatio temporal parameters of gait [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ]
    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).


Secondary Outcome Measures :
  1. 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.

  2. 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.


  3. Changes in knee-flexors maximal isometric muscle strength [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ]
    Changes in knee-flexors maximal isometric strength (Newton) will be assessed by using a hand-held dynamometer.

  4. Electromyography (EMG) measurement during the tests [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ]
    Electromyography values will be taken from hamstrings during the performance of gait analysis and dynamometry

  5. Changes in thermography on hamstrings areas [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ]
    A thermography image will be taken every day of assessment. Changes in colour pixels will be analysed to determine temperature changes.

  6. Changes in static and dynamic plantar pressure measurement [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ]
    Changes in static and dynamic plantar pressure measurement will be performed in every session by using a pressure platform.

  7. Changes in subjective perception of pain and impairment: Two questionnaire (Modified 7-item Likert Scales) [ Time Frame: 48 hours, 96 hours, 1 week ]

    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).



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Non sedentary healthy men
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942562


Locations
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Spain
Universidad San Jorge
Villanueva De Gállego, Zaragoza, Spain, 50830
Sponsors and Collaborators
Universidad San Jorge
Investigators
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Study Director: Víctor Doménech, MSc Universidad San Jorge
More Information
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Responsible Party: Universidad San Jorge
ClinicalTrials.gov Identifier: NCT03942562    
Other Study ID Numbers: PI18/208
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We don't plan to share data collected

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Universidad San Jorge:
DOMS
Healthy subjects
Pressure pain thresholds
Active Knee Extension test
 Maximal strength
Electromyography
Plantar pressure measurement
Gait analysis
Additional relevant MeSH terms:
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Myalgia
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
 Nervous System Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations