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
  Purpose

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.


Condition Intervention Phase
Frozen Shoulder
Other: a standardized physical therapy program
Other: EMSMTA
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Determining Shoulder Kinematics in the Prediction of Progress of Frozen Shoulder Syndrome: a Prediction Method, Validation of the Method, and Clinical Application

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: August 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: intervention group
intervention group: end-range mobilization/scapular mobilization treatment approach group
Other: EMSMTA
end-range mobilization/scapular mobilization treatment approach
Active Comparator: control Other: a standardized physical therapy program
passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises
Sham Comparator: control-criteria group Other: a standardized physical therapy program
passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01157221

Locations
Taiwan
School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: jiu-jenq Lin, PhD School and Graduate Institute of Physical Therapy, National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital, School of Physical Therapy, National Taiwan University
ClinicalTrials.gov Identifier: NCT01157221     History of Changes
Other Study ID Numbers: 200612088R
Study First Received: July 1, 2010
Last Updated: July 2, 2010
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 28, 2014