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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
- 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
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.
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.
- First posted29 Nov 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sui-Foon Lo, MD, Principal investigator, Department of Physical Medicine and Rehabilitation, China Medical University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Different Treatment Programs for Patients With Frozen Shoulder
- ClinicalTrials.gov ID
- NCT01249040
- Acronym / sponsor ID
- CMU93-CM-13
- Conditions
- Frozen Shoulder
- Keywords
- Frozen shoulder, pain scale, range of motion(ROM), muscle strength, shoulder arthrography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- First posted
- 29 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with shoulder pain and range of motion limitaiton
Key exclusion criteria (1 listed)
- Rotator tear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapy | Procedure or surgery | – |
| steroid intraarticular injection | Procedure or surgery | – |
Primary outcome
assess the pain scale and range of motion within 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sui-Foon Lo, MD principal investigator
Department of Physical Medicine and Rehabilitation, China Medical University Hospital
1 site in 1 country: see every site and its status.
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.