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Completed

NCT Number: NCT03942562

Temporal Relationship in Recovery of Muscular Pain and Functional Variables 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Male

Study type

Observational

Primary location

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Registry information

Official study title

Temporal Relationship in Recovery of Muscular Pain, Functional Variables and Normal Gait Pattern in an Experimental Muscular Pain Model in Hamstrings

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 8, 2019
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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