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.

Study Overview

• Status: Completed
• Conditions: Frozen Shoulder
• Intervention / Treatment: Other: EMSMTA; Other: a standardized physical therapy program

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • School and Graduate Institute of Physical Therapy, National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Range of motion	pre 4 weeks 8 weeks
Disability assessment	pre 4 weeks 8 weeks
Shoulder complex kinematics	pre 4 weeks 8 weeks

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: jiu-jenq Lin, PhD, School and Graduate Institute of Physical Therapy, National Taiwan University

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (ACTUAL): June 1, 2010
• Study Completion (ACTUAL): June 1, 2010

Study Registration Dates

• First Submitted: July 1, 2010
• First Submitted That Met QC Criteria: July 2, 2010
• First Posted (ESTIMATE): July 5, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): July 5, 2010
• Last Update Submitted That Met QC Criteria: July 2, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 200612088R