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

Pain, Muscle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942562
• Other study ID #: PI18/208
• Status: Completed
• Start date: October 15, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2020
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Myalgia
• Pain, Muscle

Locations

Country	Name	City	State
Spain	Universidad San Jorge	Villanueva De Gállego	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in spatio temporal parameters of gait	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	Changes in Pressure Pain Thresholds	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
Secondary	Changes in active knee extension test	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
Secondary	Changes in knee-flexors maximal isometric muscle strength	Changes in knee-flexors maximal isometric strength (Newton) will be assessed by using a hand-held dynamometer.	Baseline, 48 hours, 96 hours, 1 week
Secondary	Electromyography (EMG) measurement during the tests	Electromyography values will be taken from hamstrings during the performance of gait analysis and dynamometry	Baseline, 48 hours, 96 hours, 1 week
Secondary	Changes in thermography on hamstrings areas	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
Secondary	Changes in static and dynamic plantar pressure measurement	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
Secondary	Changes in subjective perception of pain and impairment: Two questionnaire (Modified 7-item Likert Scales)	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