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

Frozen Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169206
• Other study ID #: 910177
• Status: Completed
• Phase: N/A
• First received: June 19, 2014
• Last updated: June 19, 2014
• Start date: October 2012
• Est. completion date: January 2014

Study information

• Verified date: June 2014
• Source: Mashhad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Radiation:
• Bilateral shoulder anteroposterior radiography
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mashhad University of Medical Sciences	Mashhad	Khorasan-Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Center equator distance	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.	one year	No
Other	Scapulohumeral angle	Scapulohumeral angle (SHA): The angle formed between humeral shaft axis and lateral border of scapula starting from the inferior angle is called scapulohumeral angle.	one year	No
Other	Acromiohumeral distance	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).	one year	No
Primary	Radiographic parameter (scapulothoracic angle) measured in angle		one year	No