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Frozen ShoulderNCT01249040

The Study of Different Treatment Programs for Patients With Frozen Shoulder

A study testing Physical therapy and steroid intraarticular injection in people with Frozen Shoulder, run by China Medical University Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Frozen Shoulder
What is being tested?
Physical therapy and steroid intraarticular injection
How many people
30 participants
Where
1 siteTaiwan
Study dates
Start not givento not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with shoulder pain and range of motion limitaiton

Who cannot join

  • Rotator tear

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Department of Physical Medicine and Rehabilitation, China Medical University Hospital

    Taichung, 404

    Sui-Foon Lo, MD, +886-4-22062121 ext. 7390, d4659@www.cmuh.org.tw

    Recruiting

Other trials in Taiwan

About this study

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.

Read more

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.

Read the 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.

Conditions
Frozen Shoulder
Being tested
Physical therapy, steroid intraarticular injection
Keywords
Frozen shoulder, pain scale, range of motion(ROM), muscle strength, shoulder arthrography
Medical subject headings
Bursitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical therapyProcedure or surgery

  • steroid intraarticular injectionProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assess the pain scale and range of motion within 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01249040
Sponsor's protocol ID
CMU93-CM-13
Status last verified
Sep 2004
First submitted
24 Nov 2010
Last updated
29 Nov 2010
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Physical therapy and steroid intraarticular injection in people with Frozen Shoulder, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sui-Foon Lo, MD (+886-4-22052121 ext. 7390, d4659@www.cmuh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assess the pain scale and range of motion within 6 weeks. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2010.

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