Prediction Frozen Shoulder Validation

NCT01157221 | Completed Phase 1 DMC

• 1 other identifier: 200612088R
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frozen Shoulder

Outcome Measures

Primary Outcomes (3)

• Range of motion

  pre 4 weeks 8 weeks

• Disability assessment

  pre 4 weeks 8 weeks

• Shoulder complex kinematics

  pre 4 weeks 8 weeks

Study Arms (3)

intervention group

EXPERIMENTAL

intervention group: end-range mobilization/scapular mobilization treatment approach group

Other: EMSMTA

control

ACTIVE COMPARATOR

Other: a standardized physical therapy program

control-criteria group

SHAM COMPARATOR

Other: a standardized physical therapy program

Interventions

a standardized physical therapy program OTHER

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

control; control-criteria group

EMSMTA OTHER

end-range mobilization/scapular mobilization treatment approach

intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• % 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);
• and duration of complaints of at least 3 months.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• jiu-jenq Lin, PhD

  School and Graduate Institute of Physical Therapy, National Taiwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 5, 2010
• Study Start: August 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 5, 2010

Record last verified: 2010-06

Locations

TW (1)