Adhesive CapsulitisNCT04364425
Steroid Injection for Adhesive Capsulitis
A study testing Triamcinolone Acetonide, lidocaine hydrochloride and Normal saline 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 low dose steroid with high dose steroid for treating adhesive capsulitis. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Triamcinolone Acetonide, lidocaine hydrochloride and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2020to Sep 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of adhesive capsulitis
- a duration of complaints more than 3 months
- a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.
Who cannot join
- prior manipulation of the affected shoulder under anesthesia;
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,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 hyaluronic acid;
- 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 veteran general hospital
Taipei
Jia chi Wang, jcwang0726@gmail.com
About this study
Official title: Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis
This study was conducted to compare the efficacy of hydrodilatation with low dose steroid with high dose steroid for treating adhesive capsulitis.
Read the detailed description
Design: a prospective, double-blinded, randomized, clinical trial
Patient and methods:
Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with low dose steroid ) and group 2 (hydrodilatation with high dose steroid). 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, Shoulder Pain And Disability Index
- Conditions
- Adhesive Capsulitis
- Being tested
- Triamcinolone Acetonide, lidocaine hydrochloride, Normal saline
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called triamcinolone acetonide 10mg/ml (Shincort, YSP, Taiwan)
ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide
lidocaine hydrochlorideDrug
Also called lidocaine hydrochloride (Xylocaine)
Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
Normal salineDrug
Ultrasound guided injection using 15ml or 12 ml of normal saline
| Study group | Role | What they receive |
|---|---|---|
| low dose steroid | Experimental | patient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS Receives: Drug: Triamcinolone Acetonide; Drug: lidocaine hydrochloride; Drug: Normal saline |
| high dose steroid | Active comparator | patient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS Receives: Drug: Triamcinolone Acetonide; Drug: lidocaine hydrochloride; Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain intensity
pain intensity was measured by visual analog scale (0-10)
Measured: 0, 6, 12 wks.
Secondary outcomes (2)
change in 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, 6, 12 wks.
change in glenohumeral joint range of motion
Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
Measured: 0, 6, 12 wks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start4 May 2020
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 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
- NCT04364425
- Sponsor's protocol ID
- 2019-07-005C
- Status last verified
- May 2020
- First submitted
- 20 Apr 2020
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang JC, Hsu PC, Wang KA, Wu WT, Chang KV. Comparative Effectiveness of Corticosteroid Dosages for Ultrasound-Guided Glenohumeral Joint Hydrodilatation in Adhesive Capsulitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):745-752. doi: 10.1016/j.apmr.2022.11.007. Epub 2022 Dec 12.
PubMed 36521580
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Low Dose and High Dose Steroid Injection for Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT04364425
- Acronym / sponsor ID
- 2019-07-005C
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 4 May 2020 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 28 Apr 2020 (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 low dose steroid with high dose steroid for treating adhesive capsulitis.
Detailed description
Design: a prospective, double-blinded, randomized, clinical trial
Patient and methods:
Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (hydrodilatation with low dose steroid ) and group 2 (hydrodilatation with high dose steroid). 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, Shoulder Pain And Disability Index
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low dose steroid | Experimental | Drug: Triamcinolone Acetonide, Drug: lidocaine hydrochloride, Drug: Normal salinepatient received ultrasound-guided 40mg triamcinolone + 4cc xylocaine + 12cc NS |
| high dose steroid | Active comparator | Drug: Triamcinolone Acetonide, Drug: lidocaine hydrochloride, Drug: Normal salinepatient received ultrasound-guided 10mg triamcinolone + 4cc xylocaine + 15cc NS |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of adhesive capsulitis
- a duration of complaints more than 3 months
- a reduction in passive range of motion in at least 2 of the following: forward flexion, abduction, or external rotation of the affected shoulder of more than 30 degree compared with the other side.
Key exclusion criteria (7 listed)
- prior manipulation of the affected shoulder under anesthesia;
- other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions, osteoarthritis, damage to the glenohumeral cartilage,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 hyaluronic acid;
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 AcetonideAlso: triamcinolone acetonide 10mg/ml (Shincort, YSP, Taiwan)ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide | Drug | high dose steroid, low dose steroid |
| lidocaine hydrochlorideAlso: lidocaine hydrochloride (Xylocaine)Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine) | Drug | high dose steroid, low dose steroid |
| Normal salineUltrasound guided injection using 15ml or 12 ml of normal saline | Drug | high dose steroid, low dose steroid |
Primary outcome
change in pain intensity
Time frame: 0, 6, 12 wks.
pain intensity was measured by visual analog scale (0-10)
2 secondary outcomes
change in Shoulder Pain And disability index
Time frame: 0, 6, 12 wks.
change in glenohumeral joint range of motion
Time frame: 0, 6, 12 wks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Derived from this study: PubMed 36521580Wang JC, Hsu PC, Wang KA, Wu WT, Chang KV. Comparative Effectiveness of Corticosteroid Dosages for Ultrasound-Guided Glenohumeral Joint Hydrodilatation in Adhesive Capsulitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2023 May;104(5):745-752. doi: 10.1016/j.apmr.2022.11.007. Epub 2022 Dec 12.
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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 Triamcinolone Acetonide, lidocaine hydrochloride and Normal saline 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 3 inclusion and 7 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 14 May 2020. 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 Wang (0919527693, jcwang0726@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in pain intensity (time frame: 0, 6, 12 wks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04364425, which also lists 1 linked publication.
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 14 May 2020.