NCT04012203

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2019

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

November 10, 2020

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

July 2, 2019

Last Update Submit

November 9, 2020

Conditions

Musculoskeletal PainHealthyDelayed Onset Muscle Soreness

Keywords

Musculoskeletal painDelayed Onset Muscle SorenessPain mechanismsPressure Pain ThresholdMyotonometerMaximal isometric strengthManual dexterity

Outcome Measures

Primary Outcomes (2)

  • 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).

  • 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 Outcomes (5)

  • 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 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 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 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).

  • Level of catastrophizing

    Day-1 (baseline), Day-14 (1-week post-exercise).

Study Arms (1)

Healthy subjects

Participants free from any pain specific to the upper limb during the past 3 months, chronic pain or other disease.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy young-adults free of pain or disease and without history of severe injury.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad San Jorge

Villanueva de Gállego, Zaragoza, 50830, Spain

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
14 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 9, 2019

Study Start

February 4, 2019

Primary Completion

December 13, 2019

Study Completion

December 20, 2019

Last Updated

November 10, 2020

Record last verified: 2020-11

Locations

ES(1)