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Completed

NCT Number: NCT01157221

Prediction Frozen Shoulder Validation

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.

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Key information

Conditions

Frozen Shoulder Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

a standardized physical therapy program

Other

passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises

EMSMTA

Other

end-range mobilization/scapular mobilization treatment approach

Primary outcomes

  1. Range of motion

    Time frame: pre 4 weeks 8 weeks

  2. Disability assessment

    Time frame: pre 4 weeks 8 weeks

  3. Shoulder complex kinematics

    Time frame: pre 4 weeks 8 weeks

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

Determining Shoulder Kinematics in the Prediction of Progress of Frozen Shoulder Syndrome: a Prediction Method, Validation of the Method, and Clinical Application

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jul 5, 2010
Registry last updated
Jul 5, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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