免费获得国外相关药品,最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Multivariable Recovery After Exercise-induced Muscle Pain in the Forearm Muscles

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

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
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
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
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 : February 4, 2019
Actual Primary Completion Date : December 13, 2019
Actual Study Completion Date : December 20, 2019
Arms and Interventions
Group/Cohort
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 :
  1. Changes in Pressure Pain Thresholds: pressure algometry [ Time Frame: 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.

  2. Changes in subjective perception of pain and recovery: Likert Scale [ Time Frame: 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 :
  1. Changes in mechanical properties of the muscle [ Time Frame: 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.

  2. Changes in manual dexterity [ Time Frame: 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.

  3. Changes in maximal isometric force [ Time Frame: 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.

  4. Changes in active range of motion [ Time Frame: 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.

  5. Level of catastrophizing [ Time Frame: 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
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy young-adults free of pain or disease and without history of severe injury.
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.
Contacts and Locations

Locations
Layout table for location information
Spain
Universidad San Jorge
Villanueva de Gállego, Zaragoza, Spain, 50830
Sponsors and Collaborators
Universidad San Jorge
Tracking Information
First Submitted Date July 2, 2019
First Posted Date July 9, 2019
Last Update Posted Date November 10, 2020
Actual Study Start Date February 4, 2019
Actual Primary Completion Date December 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2019)
  • Changes in Pressure Pain Thresholds: pressure algometry [ Time Frame: 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 [ Time Frame: 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.
Original Primary Outcome Measures
 (submitted: July 8, 2019)
  • Changes in Pressure Pain Thresholds: pressure algometry [ Time Frame: 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. PPT 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 [ Time Frame: 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.
Change History
Current Secondary Outcome Measures
 (submitted: July 9, 2019)
  • Changes in mechanical properties of the muscle [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures
 (submitted: July 8, 2019)
  • Changes in mechanical properties of the muscle [ Time Frame: 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 myotonometry bilaterally over the forearm.
  • Changes in manual dexterity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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).

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 14 Days
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy young-adults free of pain or disease and without history of severe injury.
Condition
  • Musculoskeletal Pain
  • Healthy
  • Delayed Onset Muscle Soreness
Intervention Not Provided
Study Groups/Cohorts Healthy subjects
Participants free from any pain specific to the upper limb during the past 3 months, chronic pain or other disease.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 8, 2019)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date December 20, 2019
Actual Primary Completion Date December 13, 2019   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04012203
Other Study ID Numbers PI18/385
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Universidad San Jorge
Study Sponsor Universidad San Jorge
Collaborators Not Provided
Investigators Not Provided
PRS Account Universidad San Jorge
Verification Date November 2020