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

Sponsor

Universidad San Jorge (Other)

Overall Status

Completed

CT.gov ID

NCT03942562

Collaborator

(none)

Enrollment

Location

10.5

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

Study Type:

Observational [Patient Registry]

Actual Enrollment :

24 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 :

Oct 15, 2018

Actual Primary Completion Date :

Aug 31, 2019

Actual Study Completion Date :

Aug 31, 2019

Outcome Measures

Primary Outcome Measures

Changes in spatio temporal parameters of gait [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

Changes in Pressure Pain Thresholds [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 [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 [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 [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 [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 [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) [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

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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;