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Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position

Primary Purpose

Frozen Shoulder

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Bilateral shoulder anteroposterior radiography
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Frozen Shoulder focused on measuring Frozen shoulder, scapulothoracic angle, scapulohumeral angle, acromiohumeral distance, center equator distance, shoulder radiography

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Mashhad University of Medical Sciences

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

shoulder radiography

Arm Description

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.

Outcomes

Primary Outcome Measures

Radiographic parameter (scapulothoracic angle) measured in angle

Secondary Outcome Measures

Full Information

First Posted
June 19, 2014
Last Updated
June 19, 2014
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02169206
Brief Title
Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position
Official Title
Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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 will be included. Patients with 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 will be excluded. MR imaging will be done to exclude other pathologies and frank rotator cuff tear.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
Frozen shoulder, scapulothoracic angle, scapulohumeral angle, acromiohumeral distance, center equator distance, shoulder radiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
shoulder radiography
Arm Type
Other
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Bilateral shoulder anteroposterior radiography
Intervention Description
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. In the same position, the patient only elevates the arm up to 90 degrees of abduction.
Primary Outcome Measure Information:
Title
Radiographic parameter (scapulothoracic angle) measured in angle
Time Frame
one year
Other Pre-specified Outcome Measures:
Title
Center equator distance
Description
Center-equator distance (CED): On radiography, the humeral head center (HHC) is determined using a circular template. A perpendicular line to glenoid is drawn passing through its middle point which supposed to be the glenoid equator line (GEL). The distance between the HHC and GEL is measured in millimeters and considered positive if HHC is above and negative if HHC is below the GEL.
Time Frame
one year
Title
Scapulohumeral angle
Description
Scapulohumeral angle (SHA): The angle formed between humeral shaft axis and lateral border of scapula starting from the inferior angle is called scapulohumeral angle.
Time Frame
one year
Title
Acromiohumeral distance
Description
Acromiohumeral distance (AHD): Distance between the line drawn along the acromial lower border density and the highest point of the humeral head is measured in millimeters as acromiohumeral distance (AHD).
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad H Ebrahimzadeh, M.D.
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amir R Kachooei, M.D.
Organizational Affiliation
Mashhad University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad University of Medical Sciences
City
Mashhad
State/Province
Khorasan-Razavi
ZIP/Postal Code
91375-345
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position

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