NCT02169206

Brief Summary

This study on frozen shoulder addressed the null hypothesis that there is no difference in the motion of scapula against the thoracic wall between affected and non-affected shoulder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2012

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

Study Start

First participant enrolled

October 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

1.3 years

First QC Date

June 19, 2014

Last Update Submit

June 19, 2014

Conditions

Keywords

Frozen shoulderscapulothoracic anglescapulohumeral angleacromiohumeral distancecenter equator distanceshoulder radiography

Outcome Measures

Primary Outcomes (1)

  • Radiographic parameter (scapulothoracic angle) measured in angle

    one year

Other Outcomes (3)

  • Center equator distance

    one year

  • Scapulohumeral angle

    one year

  • Acromiohumeral distance

    one year

Study Arms (1)

shoulder radiography

OTHER

Bilateral shoulder AP standard plain x-ray in 0 and 90 degrees of arm abduction. Non-affected shoulder is used to be compared with the affected shoulder.

Radiation: Bilateral shoulder anteroposterior radiography

Interventions

1. Patient standing with the tube in front and 105 cm far from the shoulder radiating perpendicular to the cassette in the back, both arms hanging aside the trunk in 0 degrees of arm abduction, 0 degrees of rotation and 0 degrees of extension with the thumb facing forward to obtain true bilateral shoulder anteroposterior view. Voltage and exposure time differs regarding each person's body mass. 2. In the same position, the patient only elevates the arm up to 90 degrees of abduction.

shoulder radiography

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients with unilateral shoulder pain lasted for more than one month, accompanied by passive and active limitation of range of motion in all directions

You may not qualify if:

  • bilateral involvement, history of trauma, history of surgery on the affected shoulder, history of fracture, shoulder osteoarthritis, symptoms less than one month and any signs of rotator cuff tear. MRI will be done to rull out the rotator cuff tear.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mashhad University of Medical Sciences

Mashhad, Khorasan-Razavi, 91375-345, Iran

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Mohammad H Ebrahimzadeh, M.D.

    Mashhad University of Medical Sciences

    STUDY DIRECTOR
  • Amir R Kachooei, M.D.

    Mashhad University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 23, 2014

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations