NCT03246867

Brief Summary

The purpose of this study is to investigate and compare the acute effects of isolytic and static stretching training in individuals having subacromial impingement syndrome with glenohumeral internal rotation deficit. Isolytic group will receive isolytic stretching in modified cross body position. Static group will receive static stretching in modified cross body position. Stretching groups will be evaluated before and just after stretching exercise. Control group will receive no stretching. Control group will be evaluated for the first time and then will be waited until the duration of the stretching exercise program. Afterwards, second evaluation will be performed

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 11, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

August 28, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2019

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2020

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

August 8, 2017

Last Update Submit

February 20, 2020

Conditions

Keywords

isolytic stretchingstatic stretchingGlenohumeral Internal Rotation Deficit

Outcome Measures

Primary Outcomes (1)

  • Shoulder internal rotation range of motion

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

    Baseline and just after stretching exercise

Secondary Outcomes (6)

  • Posterior shoulder tightness

    Baseline and just after stretching exercise

  • Concentric strength

    Baseline and just after stretching exercise

  • Eccentric strength

    Baseline and just after stretching exercise

  • Subacromial space

    Baseline and just after stretching exercise

  • Pain

    Baseline and just after stretching exercise

  • +1 more secondary outcomes

Study Arms (3)

Isolytic stretching group

EXPERIMENTAL

The participants in this group will receive isolytic stretching in modified cross body position.

Other: Isolytic stretching group

Static stretching group

EXPERIMENTAL

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

Other: Static stretching group

Control group

ACTIVE COMPARATOR

The participants in this group will receive no stretching. They will only be evaluated.

Other: Control group

Interventions

In modified cross body position, isolytic stretching exercises will perform five times each for 15 seconds. After each stretching patient will rest for 5 seconds. When the patient contracts the agonist muscle group with 20% muscle force, the agonist muscle group is stretched at the same time for 2-4 seconds. Afterwards active-assistive stretching is done. Evaluations will be done before and just after stretching exercise.

Isolytic stretching group

In modified cross body position, active-assistive static stretching exercises will be performed 5 times each for 15 seconds. This stretching exercise is performed 5 times with 5 seconds intervals. Evaluations will be done before and just after stretching exercise.

Static stretching group

Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of subacromial impingement syndrome
  • 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
  • Pain with resisted arm elevation or external rotation as well as a minimum of 3 of 5 positive subacromial impingement syndrome tests, painful arc, pain or weakness with resisted external rotation, Neer, Hawkins and Jobe tests .
  • Ability to complete the entire study procedure

You may not qualify if:

  • An inability to elevate the involved arm greater than 140 degree in the scapular plane
  • A 50% limitation of passive shoulder range of motion in \>2 planes of motion
  • Pain \>7/10
  • A 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 Sites (1)

Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sevgi Sevi YESILYAPRAK, PhD

    Dokuz Eylul University

    STUDY DIRECTOR
  • Damla GULPINAR, MS

    Izmir Katip Celebi University

    STUDY DIRECTOR
  • Mehmet ERDURAN, MD

    Dokuz Eylul University

    STUDY DIRECTOR
  • Cem OZCAN, MD

    Izmır Katip Celebi University Atatürk Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All of participants must have subacromial impingement syndrome with glenohumeral internal rotation deficit.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are 3 groups. First group will receive isolytic stretching in modified cross body position. Second group will receive static stretching in modified cross body position. The stretching exercise will be applied five times each for 15 seconds. After each stretching there will be a resting period for 5 seconds. Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Isolytic and static stretching groups will be evaluated before and just after stretching exercise. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 8, 2017

First Posted

August 11, 2017

Study Start

August 28, 2017

Primary Completion

December 15, 2019

Study Completion

January 2, 2020

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations