Frozen ShoulderPhase 1/2NCT01157221
Prediction Frozen Shoulder Validation
A Phase 1/2 study testing a standardized physical therapy program and EMSMTA in people with Frozen Shoulder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- a standardized physical therapy program and EMSMTA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2006to Jun 2010
- Phase
- Phase 1/2
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50% 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);
- 13-15 and duration of complaints of at least 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy, National Taiwan University
Taipei, 100
About this study
Official title: Determining Shoulder Kinematics in the Prediction of Progress of Frozen Shoulder Syndrome: a Prediction Method, Validation of the Method, and Clinical Application
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
- Being tested
- a standardized physical therapy program, EMSMTA
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a standardized physical therapy programOther
passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises
EMSMTAOther
end-range mobilization/scapular mobilization treatment approach
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | intervention group: end-range mobilization/scapular mobilization treatment approach group Receives: Other: EMSMTA |
| control | Active comparator | Not described Receives: Other: a standardized physical therapy program |
| control-criteria group | Sham comparator | Not described Receives: Other: a standardized physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of motion
Measured: pre 4 weeks 8 weeks
Disability assessment
Measured: pre 4 weeks 8 weeks
Shoulder complex kinematics
Measured: pre 4 weeks 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startAug 2006
- Primary completionJun 2010
- Study completionJun 2010
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 National Taiwan 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- jiu-jenq Lin, PhD, Principal investigator, School and Graduate Institute of Physical Therapy, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157221
- Sponsor's protocol ID
- 200612088R
- Status last verified
- Jun 2010
- First submitted
- 1 Jul 2010
- Last updated
- 5 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Shoulder Kinematics in the Prediction of Progress of Frozen Shoulder Syndrome: a Prediction Method, Validation of the Method, and Clinical Application
- ClinicalTrials.gov ID
- NCT01157221
- Acronym / sponsor ID
- 200612088R
- Conditions
- Frozen Shoulder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 Jul 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: EMSMTAintervention group: end-range mobilization/scapular mobilization treatment approach group |
| control | Active comparator | Other: a standardized physical therapy program |
| control-criteria group | Sham comparator | Other: a standardized physical therapy program |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50% 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);
- 13-15 and duration of complaints of at least 3 months.
Key exclusion criteria (8 listed)
- a history of stroke with residual upper-extremity involvement,
- diabetes mellitus,
- rheumatoid arthritis,
- rotator cuff tear,
- surgical stabilization of the shoulder,
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 |
|---|---|---|
| a standardized physical therapy programpassive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises | Other | control, control-criteria group |
| EMSMTAend-range mobilization/scapular mobilization treatment approach | Other | intervention group |
Primary outcome
Range of motion
Time frame: pre 4 weeks 8 weeks
Disability assessment
Time frame: pre 4 weeks 8 weeks
Shoulder complex kinematics
Time frame: pre 4 weeks 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2010.
Related trials for Frozen Shoulder
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Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
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Ultrasound-Guided Intra-Articular vs Gluteal Intramuscular Corticosteroid Injection for Frozen Shoulder
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OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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Maitland Mobilization With and Without Stroking Release Technique of Rotator Cuff Muscle in Frozen Shoulder
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Not yet recruiting
Spencer's Technique Versus Mulligan's Technique for Stage II Frozen Shoulder
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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.
jiu-jenq Lin, PhD principal investigator
School and Graduate Institute of Physical Therapy, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing a standardized physical therapy program and EMSMTA in people with Frozen Shoulder, run by National Taiwan 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 5 Jul 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of motion (time frame: pre 4 weeks 8 weeks). The study lists 3 primary outcomes in all. 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 5 Jul 2010.