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Trial record 4 of 52 for:    "Frozen Shoulder"

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

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ClinicalTrials.gov Identifier: NCT02169206
Recruitment Status : Completed
First Posted : June 23, 2014
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Amir Reza Kachooei, Mashhad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Frozen Shoulder Radiation: Bilateral shoulder anteroposterior radiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Trial on Frozen Shoulder Using Bilateral Shoulder Radiography in Different Position
Study Start Date : October 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arm Intervention/treatment
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.
Radiation: 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.




Primary Outcome Measures :
  1. Radiographic parameter (scapulothoracic angle) measured in angle [ Time Frame: one year ]

Other Outcome Measures:
  1. Center equator distance [ Time Frame: one year ]
    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.

  2. Scapulohumeral angle [ Time Frame: one year ]
    Scapulohumeral angle (SHA): The angle formed between humeral shaft axis and lateral border of scapula starting from the inferior angle is called scapulohumeral angle.

  3. Acromiohumeral distance [ Time Frame: one year ]
    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).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02169206


Locations
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Iran, Islamic Republic of
Mashhad University of Medical Sciences
Mashhad, Khorasan-Razavi, Iran, Islamic Republic of, 91375-345
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
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Study Director: Mohammad H Ebrahimzadeh, M.D. Mashhad University of Medical Sciences
Principal Investigator: Amir R Kachooei, M.D. Mashhad University of Medical Sciences

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Responsible Party: Amir Reza Kachooei, M.D., Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02169206     History of Changes
Other Study ID Numbers: 910177
First Posted: June 23, 2014    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014
Keywords provided by Amir Reza Kachooei, Mashhad University of Medical Sciences:
Frozen shoulder
scapulothoracic angle
scapulohumeral angle
acromiohumeral distance
center equator distance
shoulder radiography
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases