Adhesive CapsulitisNCT03678038
Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder
A study testing Triamcinolone (Shincort) injection to rotator interval and Triamcinolone (Shincort) injection to posterior glenuhumeral recess in people with Adhesive Capsulitis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus rotator interval approach for treating patients with adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Triamcinolone (Shincort) injection to rotator interval and Triamcinolone (Shincort) injection to posterior glenuhumeral recess
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Sep 2018to 15 Mar 2021
- 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
- Healthy volunteers accepted
- 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 or corticosteroid
- pregnancy or lactation;
- received injection into the affected shoulder during the preceding 3 months
- history of surgeries on the affected shoulders
- Secondary frozen shoulder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder
This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus rotator interval approach for treating patients with adhesive capsulitis.
Read the detailed description
Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.
Design: a prospective, single-blinded, randomized, clinical trial
Patient and methods:
Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided rotator interval injection ) and group 2 (ultrasound guided steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, and Shoulder Pain And Disability Index.
- Conditions
- Adhesive Capsulitis
- Being tested
- Triamcinolone (Shincort) injection to rotator interval, Triamcinolone (Shincort) injection to posterior glenuhumeral recess
- 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.
Triamcinolone (Shincort) injection to rotator intervalDrug
via rotator interval.
Triamcinolone (Shincort) injection to posterior glenuhumeral recessDrug
via posterior glenuhumeral recess
| Study group | Role | What they receive |
|---|---|---|
| rotator interval injection | Experimental | patient received ultrasound-guided steroid injection via rotator interval Receives: Drug: Triamcinolone (Shincort) injection to rotator interval |
| posterior recess injection | Active comparator | patient received ultrasound-guided steroid injection via posterior recess Receives: Drug: Triamcinolone (Shincort) injection to posterior glenuhumeral recess |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.function. The score is divided into four sections: pain, activity of daily living, ROM and strength
Measured: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
Secondary outcomes (2)
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: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
glenohumeral joint range of motion
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position
Measured: Change at baseline, 6 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start28 Sep 2018
- Primary completion15 Jan 2021
- Study completion15 Mar 2021
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678038
- Sponsor's protocol ID
- 2018-07-008B
- Status last verified
- Apr 2021
- First submitted
- 9 Sep 2018
- Last updated
- 28 Apr 2021
- 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 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder
- ClinicalTrials.gov ID
- NCT03678038
- Acronym / sponsor ID
- 2018-07-008B
- Conditions
- Adhesive Capsulitis
- Keywords
- adhesive capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 19 Sep 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.
This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus rotator interval approach for treating patients with adhesive capsulitis.
Detailed description
Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.
Design: a prospective, single-blinded, randomized, clinical trial
Patient and methods:
Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided rotator interval injection ) and group 2 (ultrasound guided steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, and Shoulder Pain And Disability Index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rotator interval injection | Experimental | Drug: Triamcinolone (Shincort) injection to rotator intervalpatient received ultrasound-guided steroid injection via rotator interval |
| posterior recess injection | Active comparator | Drug: Triamcinolone (Shincort) injection to posterior glenuhumeral recesspatient received ultrasound-guided steroid injection via posterior recess |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of frozen shoulder by physical examination and ultrasonography
Key exclusion criteria (8 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 or corticosteroid
- 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 |
|---|---|---|
| Triamcinolone (Shincort) injection to rotator intervalvia rotator interval. | Drug | rotator interval injection |
| Triamcinolone (Shincort) injection to posterior glenuhumeral recessvia posterior glenuhumeral recess | Drug | posterior recess injection |
Primary outcome
Shoulder Pain And disability index
Time frame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
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.function. The score is divided into four sections: pain, activity of daily living, ROM and strength
2 secondary outcomes
pain intensity
Time frame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
glenohumeral joint range of motion
Time frame: Change at baseline, 6 weeks, 12 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 28 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone (Shincort) injection to rotator interval and Triamcinolone (Shincort) injection to posterior glenuhumeral recess 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 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 28 Apr 2021. 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?
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?
Shoulder Pain And disability index (time frame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline). 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 28 Apr 2021.