免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / 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 and Functional Variables in an Experimental Muscular Pain Model in Hamstrings

Study Description
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
Layout table for study information
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
Arms and Interventions
Outcome Measures
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
Layout table for eligibility information
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

Locations
Layout table for location information
Spain
Universidad San Jorge
Villanueva De Gállego, Zaragoza, Spain, 50830
Sponsors and Collaborators
Universidad San Jorge
Investigators
Layout table for investigator information
Study Director: Víctor Doménech, MSc Universidad San Jorge
Tracking Information
First Submitted Date May 6, 2019
First Posted Date May 8, 2019
Last Update Posted Date November 10, 2020
Actual Study Start Date October 15, 2018
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 9, 2019)
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).
Original Primary Outcome Measures
 (submitted: May 7, 2019)
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 OptoGait System (an optical measurement system consisting of a transmitting and receiving bar).
Change History
Current Secondary Outcome Measures
 (submitted: May 9, 2019)
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures
 (submitted: May 7, 2019)
  • Changes in Pressure Pain Thresholds [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ]
    Changes in pressure pain thresholds 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.
  • 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.
  • 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.
  • 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
  • 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 pixeles will be analysed to determine temperature changes.
  • Changes in static and dynamic baropodometry [ Time Frame: Baseline, 48 hours, 96 hours, 1 week ]
    Changes in static and dynamic baropodometry will be performed in every session by using a pressure platform.
  • Changes in subjective perception of pain and impairment: Two questionnaire (Modified 7-item Likert Scales) [ Time Frame: 48 hours, 96 hours, 1 week ]
    Two questionnaire (Modified 7-item Likert Scales) are filled up by the subject to show subjective perception of pain related to movement along the recovery period
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Temporal Relationship in Recovery of Muscular Pain and Functional Variables in an Experimental Muscular Pain Model in Hamstrings
Official Title Temporal Relationship in Recovery of Muscular Pain, Functional Variables and Normal Gait Pattern in an Experimental Muscular Pain Model in Hamstrings
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.

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 Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 7 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Non sedentary healthy men
Condition Pain, Muscle
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 9, 2020)
24
Original Estimated Enrollment
 (submitted: May 7, 2019)
20
Actual Study Completion Date August 31, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility 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;
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03942562
Other Study ID Numbers PI18/208
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: We don't plan to share data collected
Responsible Party Universidad San Jorge
Study Sponsor Universidad San Jorge
Collaborators Not Provided
Investigators
Study Director: Víctor Doménech, MSc Universidad San Jorge
PRS Account Universidad San Jorge
Verification Date November 2020