NCT03993223

Brief Summary

The healthy overhead athletes with and without upper trapezius myofascial trigger point will be asked to perform a scapular elevation task until the upper trapezius muscle fatigue. The first hypothesis is that the subjects with upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities when compared to subjects without upper trapezius myofascial trigger point. Besides, the investigators suggest that subjects with/without upper trapezius myofascial trigger point will show significant difference in scapular kinematics and muscles activities after upper trapezius muscle fatigue, especially in subjects with upper trapezius myofascial trigger point.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2019

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2019

Completed
5 days until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

June 12, 2019

Last Update Submit

February 28, 2022

Conditions

Keywords

Upper trapeziusMyofascial Trigger PointMuscle fatigueOverhead athlete

Outcome Measures

Primary Outcomes (2)

  • Scapular kinematics

    Change of scapular kinematics immediately after fatigue task

    10 minutes

  • Scapular muscles electromyography

    Change of scapular muscles electromyography immediately after fatigue task

    10 minutes

Study Arms (2)

MTrP group

EXPERIMENTAL

Healthy overhead athletes with upper trapezius myofascial trigger point

Behavioral: Upper trapezius muscle fatigue

Control group

SHAM COMPARATOR

Healthy overhead athletes without upper trapezius myofascial trigger point

Behavioral: Upper trapezius muscle fatigue

Interventions

Isometric contraction of scapular elevation

Control groupMTrP group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old active overhead athletes
  • No symptoms in the shoulder of dominant side in the past 6 months
  • Regularly perform overhead sports activity ≥ 3 hr/wk for more than 6 months

You may not qualify if:

  • History of major shoulder/cervical injury or surgery in the past 6 months
  • Experiencing shoulder pain, or participating in rehabilitation for shoulder pain in the past 6 months before the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan university hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Myofascial Pain SyndromesFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Data were collected by the attending surgeon who was blinded to the group assignment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The treatment allocation and procedures involved in this randomized study were explained to all participants when they met inclusion criteria of VAS score of 4 or greater on the postoperative first day.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2019

First Posted

June 20, 2019

Study Start

June 17, 2019

Primary Completion

May 31, 2021

Study Completion

February 28, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations