Adhesive CapsulitisNCT03622853
What Factors Area Associated With Prognosis After Steroid Hydrodilatation for Adhesive Capsulitis
A study testing Steroid (shincort) in people with Adhesive Capsulitis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Steroid (shincort)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 1 Mar 2019
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of frozen shoulder by physical examination and ultrasonography
Who cannot join
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
- neurologic deficits affecting shoulder function in normal daily activities;
- shoulder pain caused by cervical radiculopathy
- a history of drug allergy to xylocaine
- pregnancy or lactation;
- received injection into the affected shoulder during the preceding 3 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 241
Jia c Wang, 919527693, jcwang0726@gmail.com
About this study
To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
Read the detailed description
Objective: To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
Design: Prospective study.
Participants: Patients with Frozen shoulder were recorded the demographic data, associated disease, ultrasound findings at baselines.
Intervention: One shot intraarticular steroid hydrodilatation
Main Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active and passive shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 8
- Conditions
- Adhesive Capsulitis
- Being tested
- Steroid (shincort)
- Keywords
- adhesive capsulitis
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid (shincort)Drug
Also called shincort
intraarticular shincort 40mg / 4ml mixed with 2% xylocaine and Normal saline
| Study group | Role | What they receive |
|---|---|---|
| intraarticular steroid injection | Experimental | intraarticular steroid hydrodilatation (shincort 40mg ) Receives: Drug: Steroid (shincort) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of constant shoulder score between week 0 and week 8
the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength
Measured: 0 and 8 wks
Secondary outcomes (3)
pain intensity
pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.
Measured: 0 and 8 wks
Shoulder Pain And disability index
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.
Measured: 0 and 8 wks
glenohumeral joint range of motion
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position
Measured: 0 and 8 wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start1 Jan 2018
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622853
- Sponsor's protocol ID
- 2017-02-005c
- Status last verified
- Aug 2018
- First submitted
- 29 Mar 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Factors Area Associated With Prognosis After Steroid Hydrodilatation for Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT03622853
- Acronym / sponsor ID
- 2017-02-005c
- Conditions
- Adhesive Capsulitis
- Keywords
- adhesive capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 9 Aug 2018 (actual)
- 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.
To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
Detailed description
Objective: To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
Design: Prospective study.
Participants: Patients with Frozen shoulder were recorded the demographic data, associated disease, ultrasound findings at baselines.
Intervention: One shot intraarticular steroid hydrodilatation
Main Outcome Measures: Visual analog scale (VAS) of the shoulder pain, Constant score, SPADI score, and angles of active and passive shoulder range of motion (flexion, abduction, external rotation, and internal rotation) at pre-treatment, post-treatment at week 8
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To investigate the factors associated with improvement after intraarticular steroid injection for patients with Frozen shoulder
| Arm | Type | Receives |
|---|---|---|
| intraarticular steroid injection | Experimental | Drug: Steroid (shincort)intraarticular steroid hydrodilatation (shincort 40mg ) |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of frozen shoulder by physical examination and ultrasonography
Key exclusion criteria (6 listed)
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
- neurologic deficits affecting shoulder function in normal daily activities;
- shoulder pain caused by cervical radiculopathy
- a history of drug allergy to xylocaine
- pregnancy or lactation;
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 |
|---|---|---|
| Steroid (shincort)Also: shincortintraarticular shincort 40mg / 4ml mixed with 2% xylocaine and Normal saline | Drug | intraarticular steroid injection |
Primary outcome
The change of constant shoulder score between week 0 and week 8
Time frame: 0 and 8 wks
the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength
3 secondary outcomes
pain intensity
Time frame: 0 and 8 wks
Shoulder Pain And disability index
Time frame: 0 and 8 wks
glenohumeral joint range of motion
Time frame: 0 and 8 wks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid (shincort) in people with Adhesive Capsulitis, run by Taipei Veterans General Hospital, Taiwan 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 6 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 9 Aug 2018. 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 Jia chi c Wang, MD (919527693, jcwang0726@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of constant shoulder score between week 0 and week 8 (time frame: 0 and 8 wks). 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 9 Aug 2018.