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

Sponsor

Universidad San Jorge (Other)

Overall Status

Completed

CT.gov ID

NCT04012203

Collaborator

(none)

Enrollment

Location

10.5

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Musculoskeletal Pain Healthy Delayed Onset Muscle Soreness

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).

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Feb 4, 2019

Actual Primary Completion Date :

Dec 13, 2019

Actual Study Completion Date :

Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Healthy subjects Participants free from any pain specific to the upper limb during the past 3 months, chronic pain or other disease.

Outcome Measures

Primary Outcome Measures

Changes in Pressure Pain Thresholds: pressure algometry [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).]
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.
Changes in subjective perception of pain and recovery: Likert Scale [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).]
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.

Secondary Outcome Measures

Changes in mechanical properties of the muscle [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).]
Changes in mechanical properties of the muscle will be determined with myotonometer bilaterally over the forearm.
Changes in manual dexterity [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).]
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.
Changes in maximal isometric force [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).]
Changes in wrist extensors maximal isometric strength will be assessed with hand-held dynamometry.
Changes in active range of motion [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).]
Changes in active range of motion of the wrist will be assessed in both sides using a digital inclinometer.
Level of catastrophizing [Day-1 (baseline), Day-14 (1-week post-exercise).]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.