Prediction Frozen Shoulder Validation

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01157221
First received: July 1, 2010
Last updated: July 2, 2010
Last verified: June 2010

July 1, 2010
July 2, 2010
August 2006
June 2010   (final data collection date for primary outcome measure)
  • Range of motion [ Time Frame: pre 4 weeks 8 weeks ] [ Designated as safety issue: No ]
  • Disability assessment [ Time Frame: pre 4 weeks 8 weeks ] [ Designated as safety issue: No ]
  • Shoulder complex kinematics [ Time Frame: pre 4 weeks 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01157221 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Prediction Frozen Shoulder Validation
Determining Shoulder Kinematics in the Prediction of Progress of Frozen Shoulder Syndrome: a Prediction Method, Validation of the Method, and Clinical Application

Background: Few studies have examined the predictors of the clinical course of subjects with frozen shoulder syndrome or explained the persistence of symptoms after appropriate therapy. Altered shoulder kinematics may predispose subjects to subacromial impingement, rotator cuff tendonitis, altered shoulder joint forces, and possible degenerative changes. Subsequently, a more difficult and chronic course of frozen shoulder syndrome may develop.

Objective: The purposes of this study are: (1) to develop a prediction method for determining altered shoulder kinematics and associated muscular activities which are associated with the chronicity of frozen shoulder dysfunction, and (2) to validate this prediction method and analyze the impact of the method on clinical behavior.

Design: For the first year, a prospective study will be conducted to develop a prediction method that will identify impaired shoulder kinematics associated with the degree of symptom-related functional disability in patients with frozen shoulder syndrome. For the second and third years, validation of the proposed prediction method will determine whether altered shoulder kinematics and associated muscular activities subject to intervention meet the prediction criteria and demonstrate improvement in their follow-up, which will be shown to improve decision making in clinical practice.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Frozen Shoulder
  • Other: a standardized physical therapy program
    passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises
  • Other: EMSMTA
    end-range mobilization/scapular mobilization treatment approach
  • Experimental: intervention group
    intervention group: end-range mobilization/scapular mobilization treatment approach group
    Intervention: Other: EMSMTA
  • Active Comparator: control
    Intervention: Other: a standardized physical therapy program
  • Sham Comparator: control-criteria group
    Intervention: Other: a standardized physical therapy program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 50% loss of passive movement of the shoulder joint relative to the nonaffected side, in 1 or more of 3 movement directions (i.e., forward flexion, abduction in the frontal plane, or external rotation in 0° of abduction);
  • 13-15 and duration of complaints of at least 3 months.

Exclusion Criteria:

  • a history of stroke with residual upper-extremity involvement,
  • diabetes mellitus,
  • rheumatoid arthritis,
  • rotator cuff tear,
  • surgical stabilization of the shoulder,
  • osteoporosis, or
  • malignancies in the shoulder region.
  • subjects who had pain or disorders of the cervical spine, elbow, wrist, or hand, or who had pain radiating from the shoulder to the arm, were also excluded.
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01157221
200612088R
Yes
National Taiwan University Hospital, School of Physical Therapy, National Taiwan University
National Taiwan University Hospital
Not Provided
Principal Investigator: jiu-jenq Lin, PhD School and Graduate Institute of Physical Therapy, National Taiwan University
National Taiwan University Hospital
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP