Direct Coracohumeral Ligament Steroid InjectionNCT03013205
Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder
A study testing Intraarticular triamcinolone injection, Intraarticular Xylocaine injection and Coracohumeral ligament triamcinolone injection in people with Direct Coracohumeral Ligament Steroid Injection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with the frozen shoulder. In this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Direct Coracohumeral Ligament Steroid Injection
- What is being tested?
- Intraarticular triamcinolone injection, Intraarticular Xylocaine injection and Coracohumeral ligament triamcinolone injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2017to Oct 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
A.Inclusion criteria：
- Age 20-80 years old
- Unilateral shoulder pain more than 3 months
- At least one shoulder ROM limitation in three dimensions which decreased over 50% (Abduction, Flexion, External rotation)
- Visual analog scale more than 30 (total 100)
- No fracture or subluxation or arthritis in shoulder Xray.
B.Exclusion criteria：
- History of shoulder or chest surgery
- History of shoulder trauma in 2 recent years
- Ever receiving shoulder joint injection in recent 3 months
- With cervical radiculopathy or any central CNS disorders
- With osteoarthritis or rheumatic arthritis of shoulder
- Diagnosed as rotator cuff tear, tendon calcification or bursitis
- Systemic diseases including diabetes or thyroid disorder
- Allergy history of steroid
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Test1, Test2, test3
Chueh-Hung Wu, MD, 0972651208, nojred@gmail.com
About this study
Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with the frozen shoulder. In this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.
Read the detailed description
Adhesive capsulitis of the shoulder, also known as the frozen shoulder, often leads to severe pain and shoulder range of motion limitation. Steroid injections are widely utilized to reduce inflammation and fibrosis. The thickening of the coracohumeral ligament was thought to play an important role in the pathogenesis of frozen shoulder, resulting in limited external rotation of the shoulder. While the elastogram of coracohumeral ligament will significantly increase stiffness under the shear-wave ultrasound (shear-wave elastography).
Therefore, in this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.
(the patient will not have additional risk of injection under ultrasound guidance)
- Being tested
- Intraarticular triamcinolone injection, Intraarticular Xylocaine injection, Coracohumeral ligament triamcinolone injection, Physiotherapy
- 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.
Intraarticular triamcinolone injectionProcedure or surgery
triamcinolone 10mg/mL
Intraarticular Xylocaine injectionProcedure or surgery
Xylocaine 1% 4ml
Coracohumeral ligament triamcinolone injectionProcedure or surgery
triamcinolone 10mg/mL
PhysiotherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PT+IA+CHL | Experimental | 1. Intraarticular triamcinolone injection
2. Intraarticular Xylocaine injection
3. Coracohumeral ligament triamcinolone injection
4. Physiotherapy Receives: Procedure: Intraarticular triamcinolone injection; Procedure: Intraarticular Xylocaine injection; Procedure: Coracohumeral ligament triamcinolone injection; Procedure: Physiotherapy |
| PT+IA | Active comparator | 1. Intraarticular triamcinolone injection
2. Intraarticular Xylocaine injection
3. Physiotherapy Receives: Procedure: Intraarticular triamcinolone injection; Procedure: Intraarticular Xylocaine injection; Procedure: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement
shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100
Measured: 2 years
Secondary outcomes (3)
Change of Visual analogue scale
Visual analogue scale: scale 0-10
Measured: 2 years
Shoulder range of motion improvement
Range of motion improvement: flexion, abduction, external rotation (degree)
Measured: 2 years
Stiffness of coracohumeral ligament under elastogram (KPa)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Direct Coracohumeral Ligament Steroid InjectionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chueh-Hung Wu, MD, Principal investigator, NTUH PMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013205
- Sponsor's protocol ID
- 201609026RINB
- Status last verified
- Jan 2017
- First submitted
- 26 Dec 2016
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder
- ClinicalTrials.gov ID
- NCT03013205
- Acronym / sponsor ID
- 201609026RINB
- Keywords
- adhesive capsulitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 6 Jan 2017 (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.
Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with the frozen shoulder. In this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.
Detailed description
Adhesive capsulitis of the shoulder, also known as the frozen shoulder, often leads to severe pain and shoulder range of motion limitation. Steroid injections are widely utilized to reduce inflammation and fibrosis. The thickening of the coracohumeral ligament was thought to play an important role in the pathogenesis of frozen shoulder, resulting in limited external rotation of the shoulder. While the elastogram of coracohumeral ligament will significantly increase stiffness under the shear-wave ultrasound (shear-wave elastography).
Therefore, in this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.
(the patient will not have additional risk of injection under ultrasound guidance)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT+IA+CHL | Experimental | Procedure: Intraarticular triamcinolone injection, Procedure: Intraarticular Xylocaine injection, Procedure: Coracohumeral ligament triamcinolone injection, Procedure: Physiotherapy1. Intraarticular triamcinolone injection 2. Intraarticular Xylocaine injection 3. Coracohumeral ligament triamcinolone injection 4. Physiotherapy |
| PT+IA | Active comparator | Procedure: Intraarticular triamcinolone injection, Procedure: Intraarticular Xylocaine injection, Procedure: Physiotherapy1. Intraarticular triamcinolone injection 2. Intraarticular Xylocaine injection 3. Physiotherapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Intraarticular triamcinolone injectiontriamcinolone 10mg/mL | Procedure or surgery | PT+IA, PT+IA+CHL |
| Intraarticular Xylocaine injectionXylocaine 1% 4ml | Procedure or surgery | PT+IA, PT+IA+CHL |
| Coracohumeral ligament triamcinolone injectiontriamcinolone 10mg/mL | Procedure or surgery | PT+IA+CHL |
| Physiotherapy | Procedure or surgery | PT+IA, PT+IA+CHL |
Primary outcome
Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement
Time frame: 2 years
shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100
3 secondary outcomes
Change of Visual analogue scale
Time frame: 2 years
Shoulder range of motion improvement
Time frame: 2 years
Stiffness of coracohumeral ligament under elastogram (KPa)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2017.
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.
Chueh-Hung Wu, MD principal investigator
NTUH PMR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraarticular triamcinolone injection, Intraarticular Xylocaine injection and Coracohumeral ligament triamcinolone injection in people with Direct Coracohumeral Ligament Steroid Injection, 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?
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 6 Jan 2017. 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 Chueh-Hung Wu (0972651208, nojred@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement (time frame: 2 years). 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 6 Jan 2017.