NCT03186287

Brief Summary

The purpose of this study is to investigate and compare the effects of eccentric and concentric strength training on pain, strength, joint position sense and function in patients with subacromial impingement syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 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

June 9, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 21, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2020

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2.5 years

First QC Date

June 9, 2017

Last Update Submit

April 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Shoulder Function

    Change of Constant Murley Score

    Baseline, 12 weeks and 24 weeks

Secondary Outcomes (5)

  • Pain intensity

    Baseline, 12 weeks and 24 weeks

  • Upper extremity function

    Baseline, 12 weeks and 24 weeks

  • Isometric strength

    Baseline, 12 weeks and 24 weeks

  • Eccentric strength

    Baseline, 12 weeks and 24 weeks

  • Joint position sense

    Baseline, 12 weeks and 24 weeks

Study Arms (3)

Eccentric training group

EXPERIMENTAL

The participants in this group will actively perform eccentric phase of resistive shoulder exercises. Additionally they will receive standard physiotherapy.

Other: Eccentric trainingOther: Standard physiotherapy

Concentric training group

EXPERIMENTAL

The participants in this group will actively perform concentric phase of resistive shoulder exercises. Additionally they will receive standard physiotherapy.

Other: Concentric trainingOther: Standard physiotherapy

Control group

ACTIVE COMPARATOR

The participants in this group will receive only standard physiotherapy.

Other: Standard physiotherapy

Interventions

Eccentric phase of resistive shoulder exercises will be performed three sets of 15 repetitions once a day for 12 weeks using therabands. Participants will be supervised by the physiotherapist 3 days a week for the first 6 weeks, 2 days a week for the next 3 weeks and 1 day a week for the last 3 weeks.

Eccentric training group

Concentric phase of resistive shoulder exercises will be performed three sets of 15 repetitions once a day for 12 weeks using therabands. Participants will be supervised by the physiotherapist 3 days a week for the first 6 weeks, 2 days a week for the next 3 weeks and 1 day a week for the last 3 weeks.

Concentric training group

The participants will receive standard physiotherapy. The standard physiotherapy exercises will be supervised by the physiotherapist, same as intervention exercises.

Concentric training groupControl groupEccentric training group

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of subacromial impingement syndrome
  • Complaints associated with subacromial impingement syndrome for at least 3 months
  • No extra pain with 90 degree abduction-90 degree external rotation position of the shoulder
  • Ability to complete the entire study procedure

You may not qualify if:

  • Severe pain; shoulder pain is \> 7/10
  • History of upper extremity fracture
  • History of shoulder, cervical and thoracic surgery
  • Having shoulder instability or frozen shoulder diagnosis
  • History of shoulder injuries, trauma and / or shoulder symptoms requiring treatment during the last 1 year (except than subacromial impingement syndrome)
  • Full-thickness rotator cuff tear
  • Systemic musculoskeletal disease
  • Neck and shoulder pain with cervical spine movement
  • Chest deformity or scoliosis diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University, School of Physical Therapy and Rehabilitation

Izmir, Balçova, 35340, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Damla KARABAY, MSc

    Izmir Katip Celebi University

    PRINCIPAL INVESTIGATOR
  • 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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

June 9, 2017

First Posted

June 14, 2017

Study Start

September 21, 2017

Primary Completion

March 16, 2020

Study Completion

March 16, 2020

Last Updated

April 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations