NCT02688205

Brief Summary

Shoulder problems cause substantial disability in daily living, work, leisure activity, and exercise. The presence of shoulder problem such as rotator cuff pathology reported was highly predictive of impaired health-related quality of life. Many tests were used for physical examination of the shoulder. The reliability and validity of the tests have been studied before. However, a systemic review concluded that there was conflicting evidence in reliability of each or combined tests. Functional examination of the shoulder by Cyriax is composed of a series of tests to evaluate a shoulder problem. It includes three arm elevation, three tests for glenohumeral joints, and six resisted tests. As far as the investigators know, correlation of Cyriax functional examination with the ultrasonographic findings has never been reported before. Therefore, the aim of this study is to compare the clinical diagnosis by Cyriax's functional examination with ultrasound findings in patients with shoulder pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

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

March 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2015

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2016

Completed
Last Updated

December 23, 2020

Status Verified

February 1, 2016

Enrollment Period

1.3 years

First QC Date

May 15, 2015

Last Update Submit

December 22, 2020

Conditions

Keywords

Cyriax's functional examinationUltrasoundCorrelationResisted test

Outcome Measures

Primary Outcomes (2)

  • Cyriax's functional examination for diagnosis

    After Cyriax's functional examination for evaluating shoulder pain, a clinical diagnosis is made by the physician

    1 week

  • Ultrasound examination for diagnosis

    Ultrasound examination is done in one week after Cyriax's functional examination for detailed shoulder pathology evaluation.

    1 week

Study Arms (2)

Shoulder pain group

The participants receive Cyriax's functional examination after history taking, and will be examined by ultrasound in one week.

Other: Cyriax's functional examinationDevice: Ultrasound examination

Without shoulder pain group

The participants receive Cyriax's functional examination after history taking, and will be examined by ultrasound in one week.

Other: Cyriax's functional examinationDevice: Ultrasound examination

Interventions

included active range of motion, passive range of motion, resisted test and accessory test for shoulder pain evaluation

Shoulder pain groupWithout shoulder pain group

to evaluate rotator cuff, acromio-clavicular joint, and subdeltoid-subacromial bursa

Shoulder pain groupWithout shoulder pain group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with or without shoulder pain

You may qualify if:

  • Study group:
  • patients with unilateral or bilateral shoulder pain with unknown causes;
  • age≥ 20 years old.
  • Control group:
  • patients without unilateral or bilateral shoulder pain;
  • age≥ 20 years old.

You may not qualify if:

  • \) chronic inflammatory joint disease, infections or tumors of the shoulder, previous fracture or surgery of shoulder, and referred pain from cervical origin or visceral organs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lin-Fen Hsieh, M.D.

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2015

First Posted

February 23, 2016

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

December 23, 2020

Record last verified: 2016-02

Locations