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

NCT ID: NCT02169206

Last Updated: 2014-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-01-31

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.

Conditions

Frozen Shoulder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

shoulder radiography

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.

Group Type: OTHER

Bilateral shoulder anteroposterior radiography

Intervention Type: RADIATION

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.

Interventions

Bilateral shoulder anteroposterior radiography

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.

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mashhad University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Amir Reza Kachooei

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad H Ebrahimzadeh, M.D.

Role: STUDY_DIRECTOR

Mashhad University of Medical Sciences

Amir R Kachooei, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mashhad University of Medical Sciences

Locations

Mashhad University of Medical Sciences

Mashhad, Khorasan-Razavi, Iran

Countries

Iran

Other Identifiers

910177

Identifier Type: -

Identifier Source: org_study_id