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

November 9, 2020 updated by: Universidad San Jorge

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

Completed

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

Observational

Enrollment (Actual)

24

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

    • Zaragoza
      • Villanueva De Gállego, Zaragoza, Spain, 50830
        • Universidad San Jorge

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

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Non sedentary healthy men

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

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

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

48 hours, 96 hours, 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Víctor Doménech, MSc, Universidad San Jorge

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 15, 2018

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

May 6, 2019

First Submitted That Met QC Criteria

May 7, 2019

First Posted (Actual)

May 8, 2019

Study Record Updates

Last Update Posted (Actual)

November 10, 2020

Last Update Submitted That Met QC Criteria

November 9, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We don't plan to share data collected

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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