NCT03044236

Brief Summary

To examine and compare the effect of a novel stretching technique and traditional stretching on glenohumeral range of motion, strength, maximum voluntary contraction, pain, and subject satisfaction in overhead athletes with glenohumeral internal rotation deficits through a randomized clinical study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

June 11, 2019

Status Verified

August 1, 2018

Enrollment Period

1.9 years

First QC Date

January 30, 2017

Last Update Submit

June 10, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Glenohumeral internal rotation ROM

    The investigators will use the digital inclinometer

    Change from baseline at week 4

Secondary Outcomes (1)

  • Maximal glenohumeral external rotation isometric strength

    Change from baseline at week 4

Other Outcomes (3)

  • Mean motor unit recruitment (EMG) of the glenohumeral external rotator (infraspinatus) and internal rotators (pectoralis major and latissumus dorsi)

    Change from baseline at week 4

  • Pain will be measured using the Numeric Pain Rating Scale

    Change from baseline at week 4

  • Subject satisfaction will be measured using the Subject satisfaction Form

    Week 4

Study Arms (2)

Novel Stretching Technique

EXPERIMENTAL

Participants will perform the novel stretch in a supine position. Participants will place a small ball between their knees and squeeze the ball. Participants will be then bridge as high as possible . Participants will then flex their shoulder and elbow to 90°, and actively rotate to the end of ROM. Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch.

Procedure: Stretching

Traditional Stretching Technique

ACTIVE COMPARATOR

Participants will perform the modified sleeper stretch in a side-lying position on the side of the throwing shoulder with the throwing shoulder and elbow flexed to 90° . The participants will be instructed to allow the throwing shoulder to naturally fall into internal rotation to the end ROM where resistance will be felt . The participants will be then instructed to use the non-throwing hand to push the throwing shoulder into further internal rotation to the point of mild discomfort by applying pressure at the area of the wrist joint.

Procedure: Stretching

Interventions

StretchingPROCEDURE

The novel stretching technique will be done on a supine position. subjects will be asked bridge as high as possible. After That, Participants will then flex their shoulder and elbow to 90°. Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch.

Novel Stretching TechniqueTraditional Stretching Technique

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Participants must be between the age of 18 and 45.
  • Perform overhead sports activities in the past 3 months.
  • Participants are required to display ≥ 20° less glenohumeral internal rotation ROM in their dominant shoulder compare to the non- dominate shoulder.
  • Participants will be included with or without pain during shoulder activities.

You may not qualify if:

  • Will exclude participants who are still recovering from previous surgery of the shoulder and elbow complex in the past 3 months, and currently receiving medical intervention for the shoulder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda U

Loma Linda, California, 92354, United States

Location

Related Publications (1)

  • Gharisia O, Lohman E, Daher N, Eldridge A, Shallan A, Jaber H. Effect of a novel stretching technique on shoulder range of motion in overhead athletes with glenohumeral internal rotation deficits: a randomized controlled trial. BMC Musculoskelet Disord. 2021 Apr 30;22(1):402. doi: 10.1186/s12891-021-04292-8.

Study Officials

  • Everett Lohman, DSc

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2017

First Posted

February 6, 2017

Study Start

April 19, 2017

Primary Completion

March 19, 2019

Study Completion

June 1, 2019

Last Updated

June 11, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations