NCT04687696

Brief Summary

78 overhead athletes with Glenohumeral Internal Rotation Deficit (GIRD) will be included in this study. Participants will be randomly divided into 3 different groups of 26 people. In each group will be applied posterior shoulder stretching exercises (PSSE) performed with different Muscle Energy Techniques (MET).

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Typical duration for not_applicable

Status
unknown

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

December 22, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

1 year

First QC Date

December 22, 2020

Last Update Submit

January 9, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Shoulder internal rotation range of motion

    Change of shoulder internal rotation range of motion (with bubble inclinometer)

    baseline, 6 weeks of training, at the 1st, 3th and 6th months

Secondary Outcomes (10)

  • Subacromial space

    baseline, 6 weeks of training, at the 1st, 3th and 6th months

  • Posterior shoulder tightness

    baseline, 6 weeks of training, at the 1st, 3th and 6th months

  • Shoulder Total rotation range of motion

    baseline, 6 weeks of training, at the 1st, 3th and 6th months

  • Functional Throwing Performance Index

    baseline, 6 weeks of training, at the 1st, 3th and 6th months

  • Posterior capsule thickness

    baseline, 6 weeks of training, at the 1st, 3th and 6th months

  • +5 more secondary outcomes

Study Arms (3)

Post Isometric Relaxation Group

EXPERIMENTAL

The participants in this group will perform post isometric relaxation stretching in modified cross body position for 6 weeks.

Other: Post Isometric Relaxation Group

Isolytic Stretching Group

EXPERIMENTAL

The participants in this group will perform isolytic stretching in modified cross body position for 6 weeks..

Other: Isolytic Stretching Group

Static Stretching Group Group

EXPERIMENTAL

The participants in this group will receive static stretching in modified cross body position for 6 weeks.

Other: Static Stretching Group Group

Interventions

Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier barrier. The participants will be asked to perform an isometric contraction for 5 seconds in the horizontal abduction direction with 20% of the maximum muscle strength. After the relaxation, the arm will be moved towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between contractions.This stretching exercise will be applied in 5 repetitions in one session for 6 weeks 5 times a week.

Post Isometric Relaxation Group

Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier barrier. The participants will be asked to perform a contraction in the horizontal abduction direction with 20% of the maximum muscle strength. When the muscle contraction occurs, the arm will be moved quickly in 2-4 seconds towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between stretches. This stretching exercise will be applied in 5 repetitions in one session for 6 weeks 5 times a week.

Isolytic Stretching Group

Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier. Then, the arm will be moved towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between stretching exercises. This stretching exercise will be applied in 5 repetitions in one session for 6 weeks 5 times a week.

Static Stretching Group Group

Eligibility Criteria

Age13 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Being overhead athlete
  • Glenohumeral internal rotation range of motion of the affected shoulder should be less than other shoulder and bilateral shoulder internal rotation range of motion difference should be ≥15 º

You may not qualify if:

  • Shoulder pain required medical attention for the last year.
  • Current shoulder pain
  • Cervical pain during upper extremity movement
  • History of fracture to the shoulder girdle
  • Systemic musculoskeletal disease
  • History of shoulder surgery,
  • Glenohumeral instability (positive apprehension, relocation, or positive sulcus test) or positive findings for a full thickness rotator cuff tear (positive lag sign, positive drop arm test, or marked weakness with shoulder external rotation)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Sevgi S Yeşilyaprak, Phd

    Dokuz Eylul University

    STUDY DIRECTOR

Central Study Contacts

Gonca Şahiner Pıçak, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 22, 2020

First Posted

December 29, 2020

Study Start

February 1, 2023

Primary Completion

February 1, 2024

Study Completion

December 1, 2024

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share