The Study of Different Treatment Programs for Patients With Frozen Shoulder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by China Medical University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01249040
First received: November 24, 2010
Last updated: November 26, 2010
Last verified: September 2004
  Purpose

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.


Condition Intervention
Frozen Shoulder
Procedure: Physical therapy
Procedure: steroid intraarticular injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: The Study of Different Treatment Programs for Patients With Frozen Shoulder

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • assess the pain scale and range of motion within 6 weeks

Estimated Enrollment: 30
Detailed Description:

(A) Diagnosis: Patients with shoulder pain onset within 6 months are included in our study to evaluate shoulder range of motion (ROM) in flexion, external rotation,abduction and internal rotation by goniometer(9).Restriction in ROM is noted.Cases with possible diagnosis of frozen shoulder is arranged to receive shoulder arthrography(10,11,12)which is performed by the administration of contrast media(2ml) into joint space,followed by injection of air.Injection is discontinued when resistance is felt.The joint space capacity is defined as the total volume of contrast media and air that could be injected without resistance.All procedures are conducted by the same well experienced radiologist to keep measurement reproducible.The arthrographic findings should met at least two of the following criteria for final diagnosis of frozen shoulder:(1)joint space capacity less than 10ml;(2)irregularity of capsular margin; (3)diminished or absent axillary recess.Once frozen shoulder is confirmed,the patient is randomly arranged to receive a specific treatment program.

(B) Treatment program:

The treatment program and grouping arranged as follow:

Group 1:Physical modalities + therapeutic exercise Group 2:Physical modalities + therapeutic exercise+ intra-articular injection of steroid Gouup 3:Therapeutic exercise

(C) Sample size estimation: We assume α=0.05,power=1-α=0.95,from previous literature(10),change of ROM in flexion, abduction, external rotation, internal rotation before and after treatment was estimated as 40,40,40,20 degrees respectively,,standard deviation was 10,15,10,10 degrees respectively.Therefore,standard effective size was 4,2.6,4,2 respectively.From applied linear statistical models(13)fourth edition,1996,if α=0.05 sample size estimated as 5,7,5,10 Respectively.Therefore,sample size in each group is estimated as 10.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with shoulder pain and range of motion limitaiton

Exclusion Criteria:

  • Rotator tear
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249040

Contacts
Contact: Sui-Foon Lo, MD +886-4-22052121 ext 7390 d4659@www.cmuh.org.tw
Contact: Hsiu-Chen Lin, MS, PT +886-4-22053366 ext 3117 hclin@mail.cmu.edu.tw

Locations
Taiwan
Department of Physical Medicine and Rehabilitation, China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Sui-Foon Lo, MD    +886-4-22062121 ext 7390    d4659@www.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Sui-Foon Lo, MD Department of Physical Medicine and Rehabilitation, China Medical University Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01249040     History of Changes
Other Study ID Numbers: CMU93-CM-13
Study First Received: November 24, 2010
Last Updated: November 26, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Frozen shoulder
pain scale
range of motion(ROM)
muscle strength
shoulder arthrography

Additional relevant MeSH terms:
Bursitis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014