NCT01249040

Brief Summary

The purpose of this study is to investigate and compare different treatment programs for frozen shoulder by evaluating changes in pain scale and shoulder range of motion(ROM) before and after treatment. The investigators define frozen shoulder as shoulder pain with ROM limitation,shoulder arthrography demonstration of at least two of the following criteria:(1)reduced joint volume under 10ml; (2)irregular capsular margin;(3)diminished or absent axillary recess. Afer define diagnosis of frozen shoulder ,patients are randomly assigned to different Subgroups for different treatment programs.Each subgroup consists of ten patients. Each treatment program performed for 6 consecutive courses with each course consists of 6 days.Total 36 treatment days. The treatment programs and grouping as follow: Group 1:Physical modalities + therapeutic exercise Group 2:Physical modalities + therapeutic exercise+ intra-articular injection of steroid Gouup 3:Therapeutic exercise Before treatment,after each consecutive course (6days) of treatment,and at the end of treatment program, the investigators evaluate the range of motion and muscle strength of shoulder flexion,external rotation,abduction and internal rotation. Severity of shoulder pain also evaluated by pain scale before and after treatment program. The ROM before and after treatment program is compared by paired t-test.The ROM change before and after treatment in different groups compared by analysis of variance(ANOVA). The ROM change after consecutive treatment courses(6 days) are compared by multivariate ANOVA.Pain scale before and after treatment is compared by paired t-test.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2010

Completed
Last Updated

November 29, 2010

Status Verified

September 1, 2004

First QC Date

November 24, 2010

Last Update Submit

November 26, 2010

Conditions

Keywords

Frozen shoulderpain scalerange of motion(ROM)muscle strengthshoulder arthrography

Outcome Measures

Primary Outcomes (1)

  • assess the pain scale and range of motion within 6 weeks

Interventions

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with shoulder pain and range of motion limitaiton

You may not qualify if:

  • Rotator tear

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Medicine and Rehabilitation, China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Sui-Foon Lo, MD

    Department of Physical Medicine and Rehabilitation, China Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiu-Chen Lin, MS, PT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2010

First Posted

November 29, 2010

Last Updated

November 29, 2010

Record last verified: 2004-09

Locations