NCT03246698

Brief Summary

The purpose of this study is to investigate and compare the effect 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 stretching position and standard physiotherapy program. Static group will receive static stretching in modified cross body stretching position and standard physiotherapy program. Control group will receive only standard physiotherapy program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

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
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2019

Completed
Last Updated

July 18, 2022

Status Verified

July 1, 2022

Enrollment Period

1.8 years

First QC Date

August 8, 2017

Last Update Submit

July 14, 2022

Conditions

Keywords

Shoulder painPhysical therapyRehabilitationUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Shoulder internal rotation range of motion

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

    Baseline and 4 weeks

Secondary Outcomes (11)

  • Glenohumeral internal rotation deficit

    Baseline and 4 weeks

  • Posterior shoulder tightness

    Baseline and 4 weeks

  • Shoulder external rotation range of motion

    Baseline and 4 weeks

  • Shoulder total rotational range of motion

    Baseline and 4 weeks

  • Resting and activitiy pain in shoulder

    Baseline and 4 weeks

  • +6 more secondary outcomes

Study Arms (3)

Isolytic stretching group

EXPERIMENTAL

The participants in this group will receive isolytic stretching in modified cross body position. Additionally they will receive standard physiotherapy.

Other: Isolytic Stretching group

Static stretching group

EXPERIMENTAL

The participants in this group will receive static stretching in modified cross body position. Additionally they will receive standard physiotherapy.

Other: Static Stretching group

Control group

ACTIVE COMPARATOR

The participants in this group will receive only standard physiotherapy.

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. Isolytic stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.

Also known as: Standard physiotherapy
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. Static stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.

Also known as: Standard physiotherapy
Static stretching group

They will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total.

Also known as: Standard physiotherapy
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:

  • 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 and cervical 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)
  • Neck and shoulder pain with active/passive cervical spine movement
  • A diagnosis of chest deformity or scoliosis
  • Regularly performing posterior shoulder stretching exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylül University

Izmir, Balçova, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and InjuriesArthralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Sevgi Sevi YESILYAPRAK, PhD

    Dokuz Eylul 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 stretching position and standard physiotherapy program. Second group will receive static stretching in modified cross body stretching position and standard physiotherapy program. Control group will receive only standard physiotherapy program. In standard physiotherapy program, there are TENS, hotpack, posture and strengthening training program. Treatment program will last four weeks.
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

June 20, 2019

Study Completion

July 20, 2019

Last Updated

July 18, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations