NCT04660682

Brief Summary

The purpose of this study is to investigate and compare the long term effects of traditional and modified static cross-body posterior shoulder stretching training in individuals with subacromial impingement syndrome (SIS) having glenohumeral internal rotation deficit (GIRD). Modified cross body posterior shoulder stretching group will receive static stretching in the modified cross-body stretching position and standard physiotherapy program. The traditional cross body posterior shoulder stretching group will receive static stretching and standard physiotherapy program. The Control group will receive only sham stretching and standard physiotherapy program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

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

November 28, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

September 21, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

3 years

First QC Date

November 28, 2020

Last Update Submit

November 3, 2024

Conditions

Keywords

Glenohumeral Internal Rotation Deficit, Modified Cross-body Stretching

Outcome Measures

Primary Outcomes (2)

  • Shoulder internal rotation range of motion

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

    Baseline, 8 weeks, 12 weeks, 24 weeks

  • Glenohumeral internal rotation deficit

    Change of glenohumeral internal rotation deficit (with bubble inclinometer)

    Baseline, 8 weeks, 12 weeks, 24 weeks

Secondary Outcomes (11)

  • Posterior shoulder tightness

    Baseline, 8 weeks, 12 weeks, 24 weeks

  • Pain intensity

    Baseline, 8 weeks, 12 weeks, 24 weeks

  • Joint position sense

    Baseline, 8 weeks, 12 weeks, 24 weeks

  • Isometric strength

    Baseline, 8 weeks, 12 weeks, 24 weeks

  • Subacromial space

    Baseline, 8 weeks, 12 weeks, 24 weeks

  • +6 more secondary outcomes

Study Arms (3)

Modified static cross-body posterior shoulder stretching group

EXPERIMENTAL

The participants will perform active-assistive static stretching in the modified cross-body stretching position. Additionally, they will receive standard physiotherapy program.

Other: Modified static cross-body posterior shoulder stretching

Traditional static cross-body posterior shoulder stretching group

EXPERIMENTAL

The participants will perform active-assistive static stretching in the traditional standing cross-body stretching position. Additionally, they will receive standard physiotherapy program.

Other: Traditional static cross-body posterior shoulder stretching

Control Group

ACTIVE COMPARATOR

The participants in this group will receive sham stretching and standard physiotherapy.

Other: Control Group

Interventions

For the modified cross-body position patient will be positioned in the side-lying position to limit the scapular abduction, and the patient aligned his/her forearms to limit the ER of the humerus while moving into horizontal adduction (HAdd). First, we will ask the patient to pull his/her arm into HAdd to the physiological barrier of the ROM, and then the patient will perform active-assistive static stretching with the help of the other hand for 30 seconds. The stretching will perform five repetitions with 10-sec rest between stretches. Each stretching will begin from a new physiological barrier of the HAdd ROM. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.

Modified static cross-body posterior shoulder stretching group

For the traditional static cross-body posterior shoulder stretching, in the standing position, the patient will perform cross-body stretch alone by active-assistive pulling the humerus across the body into HAdd with the opposite arm, without concern for scapular stabilization for 30 sec. The stretching will perform five repetitions with 10-sec rest between stretches. Each stretching will begin from a new physiological barrier of the HAdd ROM. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.

Traditional static cross-body posterior shoulder stretching group

In sham stretching, the patient will be positioned in the traditional static cross body posterior shoulder stretching position, and then the patient will perform active-assistive HAdd ROM without enough stretching of the relevant tissue. Active assistive ROM will be stopped before reaching the individual PST measurement result (in this way, sham stretching will be performed without proper stretching of the relevant tissue). The HAdd ROM exercise will be performed 5 times. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.

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 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 Physical Therapy and Rehabilitation Department

Izmir, Balçova, 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, PT

    Dokuz Eylul University Physical Therapy and Rehabilitation Department

    STUDY DIRECTOR
  • Mehmet ERDURAN, MD

    Dokuz Eylul University

    STUDY DIRECTOR
  • Onur BAŞÇI, MD

    Dokuz Eylul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
All of the participants must have subacromial impingement syndrome with glenohumeral internal rotation deficit (Bilateral IRROM difference ≥ 15º )
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: There are 3 groups. The first group will receive the modified static cross-body posterior shoulder stretching and the standard physiotherapy program. The second group will receive traditional static cross-body posterior shoulder stretching and the standard physiotherapy program. The Control group will receive sham stretching and the standard physiotherapy program. In standard physiotherapy program, there are TENS, hot-pack, posture, proprioceptive, and strengthening training. The treatment program will last for eight weeks. Patients will receive the treatment program 5 days a week under the physiotherapist's supervision and 2 days a week as a home program.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

November 28, 2020

First Posted

December 9, 2020

Study Start

September 21, 2021

Primary Completion

September 21, 2024

Study Completion

September 21, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations