NCT02670174

Brief Summary

A randomized controlled trial will be conducted to examine the effectiveness of a traditional home exercise program versus 2 kinetic chain home exercise programs on treatment outcome of overhead athletes with shoulder impingement syndrome. Primary outcome measures are reduction of pain and disability, and improvement in functionality and sports performance. Secondary outcome measures are strength, mobility, flexibility and functional performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

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

Study Start

First participant enrolled

September 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

December 18, 2023

Status Verified

December 1, 2023

Enrollment Period

2.8 years

First QC Date

September 29, 2015

Last Update Submit

December 12, 2023

Conditions

Keywords

Shoulder impingement syndromeOverhead athletesKinetic chainExercise treatment

Outcome Measures

Primary Outcomes (3)

  • Changes in Shoulder Pain And Disability Index (SPADI) score

    Patients will fill in the SPADI questionnaire to evaluate shoulder pain and function. The SPADI is a valid, reliable and frequently used questionnaire for shoulder pain patients consisting of 13 items divided in 2 subscales: pain (5 items) and disability (8 items). Each item was scored on a 10-point numeric rating scale. Total and subscale scores were summed and transformed to a score out of 100 (%) were a higher score indicates a higher level of pain and/or disability

    At baseline and within one week after the 6-weeks training program

  • Changes in Western Ontario Shoulder Stability index (WOSI) score

    The WOSI is a patient-evaluated disease-specific quality of life scoring questionnaire that has been developed for shoulder instability patients. This 21-item questionnaire consists of 4 subscales: physical symptoms (10 items), sport/recreation/work (4 items), lifestyle (4 items), and emotions (3 items). Each item was scored on a 100-mm visual analogue scale. Total and subscale scores were summed and transformed to a score out of 100 (%) where a higher score indicates more limitations in shoulder related quality of life

    At baseline and within one week after the 6-weeks training program

  • Subjective perception of shoulder improvement

    A Global Rating of Change (GROC) scale was used to quantify patient-perceived improvement of overall shoulder function after 6 weeks treatment as "improved", "unchanged" or "worse". In case they improved or got worse, the amount of change was reflected on a 5-point scale: very little change, little change, some change, a large change, a very large change. An "unchanged" condition scored 0, "improved" between 1 and 5, and "worse" between -1 and -5 points. amount of change was scored on a 5-point scale (very little change, little change, some change, a large change, a very large change)

    6-weeks training program

Secondary Outcomes (6)

  • Changes in shoulder muscle isokinetic strength (Biodex system 4)

    at baseline and within one week after the 6-weeks training program

  • Changes in shoulder scapular isokinetic strength

    at baseline and within one week after the 6-weeks training program

  • Changes in scapular dyskinesis

    at baseline and within one week after the 6-weeks training program

  • Changes in functional tests for the upper limb measured with the Y Balance Test

    at baseline and within one week after the 6-weeks training program

  • Return To Play (RTP)

    up to one week after the 6-weeks training program

  • +1 more secondary outcomes

Study Arms (3)

Traditional training

ACTIVE COMPARATOR

A home exercise program consisting of rotator cuff and scapular muscle training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week.

Other: Traditional training

Separate kinetic chain training

EXPERIMENTAL

A home exercise program consisting of traditional training exercises as well as separate exercises focusing on core and lower limb training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week.

Other: Separate kinetic chain training

Integrated kinetic chain training

EXPERIMENTAL

A home exercise program consisting of traditional training exercises while integrating core and lower limb training will be performed during 6 weeks (4 sessions/week). To monitor progress and control load progression, a physical therapist will visit the subject every week.

Other: Integrated kinetic chain training

Interventions

Traditional training
Separate kinetic chain training
Integrated kinetic chain training

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Symptoms of shoulder impingement on the dominant side for at least 3 months and at least 3 of the following tests are considered positive
  • Jobe
  • Hawkins
  • Neer
  • Painful arc during elevation
  • Pain or lack of force production with isometric external rotation
  • Apprehension test
  • Relocation test
  • Performing overhead sports at least 3 hours/week
  • Shoulder pain interferes with sports activities
  • They have not had treatment for this shoulder pain

You may not qualify if:

  • History of shoulder dislocation or subluxation
  • History of orthopedic surgery
  • No complaints of pain or dysfunction in the upper limb (except impingement related complaints in the dominant shoulder), lower limb or spine at the last 6 months
  • Currently taking nonsteroidal anti-inflammatory medication
  • Received a steroid injection in the past 12 months
  • Participating in another study
  • Known systemic diseases
  • Known structural diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakgroep REVAKI (Ghent University - Ghent University hospital)

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesShoulder InjuriesWounds and Injuries

Study Officials

  • Ann Cools, PT, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Subjects are randomly assigned in 3 parallel intervention groups. They cannot participate in 2 or more intervention groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2015

First Posted

February 1, 2016

Study Start

September 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

December 18, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations