Clinical trial NCT04012203: Multivariable Recovery After Exercise-induced Muscle Pain in the Forearm Muscles
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Musculoskeletal Pain
Healthy
Delayed Onset Muscle Soreness
Keywords: Musculoskeletal pain
Delayed Onset Muscle Soreness
Pain mechanisms
Pressure Pain Threshold
Myotonometer
Maximal isometric strength
Manual dexterity
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy young-adults free of pain or disease and without history of severe injury.

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

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Pressure Pain Thresholds: pressure algometry
timeFrame: 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).
measure: Changes in subjective perception of pain and recovery: Likert Scale
timeFrame: 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 outcomes:
measure: Changes in mechanical properties of the muscle
timeFrame: 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).
measure: Changes in manual dexterity
timeFrame: 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).
measure: Changes in maximal isometric force
timeFrame: 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).
measure: Changes in active range of motion
timeFrame: 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).
measure: Level of catastrophizing
timeFrame: Day-1 (baseline), Day-14 (1-week post-exercise).
Other outcomes:
Locations:
city: Villanueva de Gállego
country: Spain
facility: Universidad San Jorge
state: Zaragoza
Study officials:
References: