Upper Trapezius Myofascial Trigger Point in Overhead Athl... | NCT03993223

Studies
Upper Trapezius Myofascial Trigger Point in Overhead Athletes After Upper Trapezius Muscle Fatigue

NCT03993223

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Mar 2, 2022Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Myofascial Trigger Point Pain
Fatigue

Interventions

Upper trapezius muscle fatigue

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2019Actual

Primary Completion Date

May 31, 2021Actual

Completion Date

Feb 28, 2022Actual

First Submitted Date

Jun 12, 2019

First Submission Date that Met QC Criteria

Jun 19, 2019

First Posted Date

Jun 20, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2022

Last Update Posted Date

Mar 2, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The investigators will recruit healthy overhead athletes with and without upper trapezius myofascial trigger point. Participants will be asked to perform a sustained scapular elevation task at their peak force until the force decrease 50 %, which indicates upper trapezius muscle fatigue. There are two purposes in the current study: (1) to compare the differences between overhead athletes with/without upper trapezius myofascial trigger point during arm elevation in scapular kinematics and muscles activities (2) to investigate the effects of upper trapezius muscle fatigue on scapular kinematics and muscles activities in overhead athletes with/without upper trapezius myofascial trigger point. 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. The outcome measurements includes scapular kinematics (upward/downward rotation, external/internal rotation, posterior/anterior tilting) and muscles activities (upper trapezius, serratus anterior, lower trapezius).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Upper trapezius muscle fatigue	Behavioral	Isometric contraction of scapular elevation	Control group MTrP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-50 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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan university hospital		Taipei			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009209	Myofascial Pain Syndromes
D005221	Fatigue

Ancestor Terms

ID	Term
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.