Multivariable Recovery After Exercise-induced Muscle Pain in the Forearm Muscles

Healthy Clinical Trial

Official title:

Temporal Relationship in Recovery of Sensory, Motor and Tissue Variables in an Experimental Exercise-induced Muscle Pain Model of the Wrist Extensor Muscles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012203
• Other study ID #: PI18/385
• Status: Completed
• Start date: February 4, 2019
• Est. completion date: December 20, 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

This study investigates the evolution of sensory, motor and tissue variables following exercise-induced pain in wrist extensor muscles in healthy subjects.

Description:

The aim of this study is to determine how is the normalization process of sensory (pressure pain thresholds, subjective pain sensation, self-recovery perception), motor (maximal isometric strength, active range of motion, manual dexterity) and tissue (myotonometer) variables after an experimental pain model in the extensor forearms muscles, by delayed onset muscle soreness after an eccentric exercise in healthy subjects. This way will be possible to establish 1) if there are differences in the time of normalization for each variable; 2) if there is a correlation between each variable and self-recovery perception. Seven assessment sessions are performed in a 14-days period. Day 0 (baseline assessment 1), Day 7 (baseline assessment 2, pre exercise), Day 7 (post exercise), Day 8 (24-hours post exercise), Day 9 (48-hours post exercise), Day 10 (72-hours post exercise), Day 14 (1-week post exercise).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 20, 2019
• Est. primary completion date: December 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Adult healthy subjects of both sexes.
• Age: 18-50.
• Being free from any pain specific to the upper limb and/or in general.

Exclusion Criteria:

• History of acute or chronic painful condition in the previous 3 months.
• Regular medication intake for any reason.
• History of severe injury in the upper extremity (e.i. fracture).
• Prior surgery in the upper limb.
• Diagnosed of any chronic pain syndrome (fibromyalgia, migraine, etc.) or severe disease.

Withdrawal Criteria:

• Being involved in new physical stimulus, which volunteer is not used to.
• Micronutrient supplementation intake.
• NSAIDs or other medication intake.

Related Conditions & MeSH terms

• Delayed Onset Muscle Soreness
• Healthy
• Musculoskeletal Pain
• Myalgia

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 Pressure Pain Thresholds: pressure algometry	Changes in pressure pain thresholds will be determined with pressure algometry bilaterally over the forearm, leg and shoulder. Pressure Pain Threshold is defined as the exact time point where the pressure is first being perceived at painful.	Day-1 (baseline assessment 1), Day-7 (baseline assessment 2, pre exercise), Day-7 (post-exercise), Day-8 (24 hours post-exercise), Day-9 (48 hours post-exercise), Day-10 (72 hours post-exercise), Day-14 (1-week post-exercise).
Primary	Changes in subjective perception of pain and recovery: Likert Scale	A modified 7-item Likert Scale for pain ("0" No pain - "6" Severely disabling pain) and a visual analogue scale (0-10 cm) for self-recovery perception will be filled up to show subjective perception along the follow-up period.	Day-1 (baseline assessment 1), Day-7 (baseline assessment 2, pre exercise), Day-7 (post-exercise), Day-8 (24 hours post-exercise), Day-9 (48 hours post-exercise), Day-10 (72 hours post-exercise), Day-14 (1-week post-exercise).
Secondary	Changes in mechanical properties of the muscle	Changes in mechanical properties of the muscle will be determined with myotonometer bilaterally over the forearm.	Day-1 (baseline assessment 1), Day-7 (baseline assessment 2, pre exercise), Day-7 (post-exercise), Day-8 (24 hours post-exercise), Day-9 (48 hours post-exercise), Day-10 (72 hours post-exercise), Day-14 (1-week post-exercise).
Secondary	Changes in manual dexterity	Changes in manual dexterity of both upper limbs will be assessed by the Nine Hole Peg Test. Participants will had to place 9 pegs in a specifically designed board as fast as possible.	Day-1 (baseline assessment 1), Day-7 (baseline assessment 2, pre exercise), Day-7 (post-exercise), Day-8 (24 hours post-exercise), Day-9 (48 hours post-exercise), Day-10 (72 hours post-exercise), Day-14 (1-week post-exercise).
Secondary	Changes in maximal isometric force	Changes in wrist extensors maximal isometric strength will be assessed with hand-held dynamometry.	Day-1 (baseline assessment 1), Day-7 (baseline assessment 2, pre exercise), Day-7 (post-exercise), Day-8 (24 hours post-exercise), Day-9 (48 hours post-exercise), Day-10 (72 hours post-exercise), Day-14 (1-week post-exercise).
Secondary	Changes in active range of motion	Changes in active range of motion of the wrist will be assessed in both sides using a digital inclinometer.	Day-1 (baseline assessment 1), Day-7 (baseline assessment 2, pre exercise), Day-7 (post-exercise), Day-8 (24 hours post-exercise), Day-9 (48 hours post-exercise), Day-10 (72 hours post-exercise), Day-14 (1-week post-exercise).
Secondary	Level of catastrophizing	Punctuation obtained in Pain Catastrophizing Scale (PCS). It comprises 13 items which focus on thoughts and feelings encountered while experiencing pain. Each item is scored from 0 (not at all) to 4 (all the time) with a total PCS score range from 0-52 points, where higher scores indicating higher levels of pain catastrophizing.	Day-1 (baseline), Day-14 (1-week post-exercise).