Adhesive Capsulitis, ShoulderNCT06987929
A Randomised Controlled Trial Comparing the Efficacy of Ultrasound-guided Hydrodilatation With Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis.
A study testing Hydrodilatation injection and Intra-articular steroid injection (IAI) in people with Adhesive Capsulitis, Shoulder, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
This study aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Adhesive Capsulitis, Shoulder
- What is being tested?
- Hydrodilatation injection and Intra-articular steroid injection (IAI)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 12 Dec 2022to 27 Nov 2023
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adhesive capsulitis or frozen shoulder, diagnosed clinically, with or without imaging,
- persistent symptoms of pain and restricted ROM for at least 3 months, despite conservative management with physiotherapy and/or analgesia
Who cannot join
- previous surgery or shoulder implants of the affected shoulder,
- history of recent trauma or fracture involving the affected shoulder,
- age below 21 years,
- pregnant women,
- any evidence of ongoing active systemic inflammatory arthritis,
- allergy to any of the injectates,
- patients on anticoagulation (warfarin or direct oral anticoagulant),
- received any joint injection in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Twenty patients with adhesive capsulitis were recruited and randomised equally to receive HD (n = 10), and IAI (n = 10). The primary outcome measures include Shoulder Pain and Disability Index (SPADI), QuickDASH questionnaire score, pain visual analogue scale (VAS) score, and range of motion (ROM) at 6-weeks post-intervention.
Read the detailed description
Adhesive capsulits is a common shoulder condition that causes significant pain and loss of joint mobility, thus affecting the quality of life. If left untreated, the symptoms can impair the person's function and persist for a longer duration. Both hydrodilatation and standard steroid injection into the glenohumeral joint are well recognised forms of treatment, but there is no consensus on the best treatment approach for adhesive capsulitis. Hydrodilatation involves injecting a larger volume of solution (with steroid and local anaesthetic mixed), into the space within the rotator cuff interval, leading to intra-articular distension of the joint capsule. The local anaesthetic used in the procedure provides immediate pain relief, while the long-term benefit comes from the resolution of the capsular stiffness and inflammation. This process stretches the capsule, resulting in adhesion breakdown and promoting the remodeling of the shoulder capsule, hence improving shoulder range of motion (ROM), especially in those with limited mobility due to the capsular tightening. This study aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Twenty patients with adhesive capsulitis were recruited and randomised equally to receive HD (n = 10), and IAI (n = 10). The primary outcome measures include Shoulder Pain and Disability Index (SPADI), QuickDASH questionnaire score, pain visual analogue scale (VAS) score, and range of motion (ROM) at 6-weeks post-intervention.
- Conditions
- Adhesive Capsulitis, Shoulder
- Being tested
- Hydrodilatation injection, Intra-articular steroid injection (IAI)
- Keywords
- Adhesive capsulitis, corticosteroid, hydrodilatation, interventional studies, intra-articular agents, pain assessment and management, ultrasonography
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrodilatation injectionProcedure or surgery
During the procedure, the patient lie supine on an examination couch, with the affected arm in the modified Crass position. All injections were done under image guidance using a Philips EPIQ ultrasound machine with an L18-12 MHz linear array transducer, performed consecutively by 2 rheumatologists or 1 pain medicine anaesthetist, all trained in MSK US. Aseptic technique was used. The transducer was placed at the short axis of the supraspinatus tendon, and the rotator cuff interval and coracohumeral ligament (CHL) were identified. Local anaesthetic (1% lignocaine) was injected subcutaneously to the skin. The therapeutic medication consisted of a mixture of 40 mg triamcinolone (10 mg/ml concentration) and 5ml 1% lignocaine, which was diluted with sterile normal saline into a total of 20mls suspension. The injection was administered using a 22-G 2-inch needle (Stimuplex A) introduced below the CHL adjacent to the long head of biceps tendon, in the in-plane view under US guidance.
Intra-articular steroid injection (IAI)Procedure or surgery
Intra-articular corticosteroid injection was performed as a control group. The posterior shoulder approach was used. The patient was positioned in the lateral decubitus or semi-prone position with the affected shoulder at the uppermost position, elbow semi-flexed and the ipsilateral arm resting on a pillow for comfort and stability. The ultrasound transducer is positioned over the long axis of the myotendinous junction of the infraspinatous tendon to view the contours of the posterior glenoid labrum and posterior portion of the humeral head. The injectate was administered using a 21-G hypodermic needle. 40 mg triamcinolone (10 mg/ml concentration) mixed with 1ml of 1% lignocaine was injected into the posterior glenohumeral joint, under ultrasound-guidance. Any adverse reaction that occurred during the procedure was recorded. Following the procedure, the patient was advised to avoid overuse of the injected joint for 24 hours as part of post-injection care.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group | Other | Not described Receives: Procedure: Intra-articular steroid injection (IAI) |
| Hydrodilation | Active comparator | Not described Receives: Procedure: Hydrodilatation injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
SPADI: self-reported questionnaire by patient on pain and disability.
Measured: 6 weeks
QuickDASH score
self-reported questionnaire by patient on upper extremity disability
Measured: 6 weeks
Pain score
self-reported by patient using visual analogue scale (VAS).
Measured: 6 weeks
Active and passive range of motions (ROM):
measured by investigators blinded to the treatments.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start12 Dec 2022
- Primary completion27 Nov 2023
- Study completion27 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis, ShoulderStudies of the same condition, open and under way.
- More trials run by Singapore General 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
- Model description
- single-centre, prospective, open-label randomised controlled study (RCT)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Chew Li Ching, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987929
- Sponsor's protocol ID
- 2022/2474
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The authors adhered to the consort recommendations for clinical trials. Study Protocol may be shared with other researchers by authors upon request.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial Comparing the Efficacy of Ultrasound-guided Hydrodilatation With Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis.
- ClinicalTrials.gov ID
- NCT06987929
- Acronym / sponsor ID
- 2022/2474
- Conditions
- Adhesive Capsulitis, Shoulder
- Keywords
- Adhesive capsulitis, corticosteroid, hydrodilatation, interventional studies, intra-articular agents, pain assessment and management, ultrasonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 27 Nov 2023 (actual)
- First posted
- 23 May 2025 (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 aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Twenty patients with adhesive capsulitis were recruited and randomised equally to receive HD (n = 10), and IAI (n = 10). The primary outcome measures include Shoulder Pain and Disability Index (SPADI), QuickDASH questionnaire score, pain visual analogue scale (VAS) score, and range of motion (ROM) at 6-weeks post-intervention.
Detailed description
Adhesive capsulits is a common shoulder condition that causes significant pain and loss of joint mobility, thus affecting the quality of life. If left untreated, the symptoms can impair the person's function and persist for a longer duration. Both hydrodilatation and standard steroid injection into the glenohumeral joint are well recognised forms of treatment, but there is no consensus on the best treatment approach for adhesive capsulitis. Hydrodilatation involves injecting a larger volume of solution (with steroid and local anaesthetic mixed), into the space within the rotator cuff interval, leading to intra-articular distension of the joint capsule. The local anaesthetic used in the procedure provides immediate pain relief, while the long-term benefit comes from the resolution of the capsular stiffness and inflammation. This process stretches the capsule, resulting in adhesion breakdown and promoting the remodeling of the shoulder capsule, hence improving shoulder range of motion (ROM), especially in those with limited mobility due to the capsular tightening. This study aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Twenty patients with adhesive capsulitis were recruited and randomised equally to receive HD (n = 10), and IAI (n = 10). The primary outcome measures include Shoulder Pain and Disability Index (SPADI), QuickDASH questionnaire score, pain visual analogue scale (VAS) score, and range of motion (ROM) at 6-weeks post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- single-centre, prospective, open-label randomised controlled study (RCT)
| Arm | Type | Receives |
|---|---|---|
| Conventional Group | Other | Procedure: Intra-articular steroid injection (IAI) |
| Hydrodilation | Active comparator | Procedure: Hydrodilatation injection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adhesive capsulitis or frozen shoulder, diagnosed clinically, with or without imaging,
- persistent symptoms of pain and restricted ROM for at least 3 months, despite conservative management with physiotherapy and/or analgesia
Key exclusion criteria (8 listed)
- previous surgery or shoulder implants of the affected shoulder,
- history of recent trauma or fracture involving the affected shoulder,
- age below 21 years,
- pregnant women,
- any evidence of ongoing active systemic inflammatory arthritis,
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 |
|---|---|---|
| Hydrodilatation injectionDuring the procedure, the patient lie supine on an examination couch, with the affected arm in the modified Crass position. All injections were done under image guidance using a Philips EPIQ ultrasound machine with an L18-12 MHz linear array transducer, performed consecutively by 2 rheumatologists or 1 pain medicine anaesthetist, all trained in MSK US. Aseptic technique was used. The transducer was placed at the short axis of the supraspinatus tendon, and the rotator cuff interval and coracohumeral ligament (CHL) were identified. Local anaesthetic (1% lignocaine) was injected subcutaneously to the skin. The therapeutic medication consisted of a mixture of 40 mg triamcinolone (10 mg/ml concentration) and 5ml 1% lignocaine, which was diluted with sterile normal saline into a total of 20mls suspension. The injection was administered using a 22-G 2-inch needle (Stimuplex A) introduced below the CHL adjacent to the long head of biceps tendon, in the in-plane view under US guidance. | Procedure or surgery | Hydrodilation |
| Intra-articular steroid injection (IAI)Intra-articular corticosteroid injection was performed as a control group. The posterior shoulder approach was used. The patient was positioned in the lateral decubitus or semi-prone position with the affected shoulder at the uppermost position, elbow semi-flexed and the ipsilateral arm resting on a pillow for comfort and stability. The ultrasound transducer is positioned over the long axis of the myotendinous junction of the infraspinatous tendon to view the contours of the posterior glenoid labrum and posterior portion of the humeral head. The injectate was administered using a 21-G hypodermic needle. 40 mg triamcinolone (10 mg/ml concentration) mixed with 1ml of 1% lignocaine was injected into the posterior glenohumeral joint, under ultrasound-guidance. Any adverse reaction that occurred during the procedure was recorded. Following the procedure, the patient was advised to avoid overuse of the injected joint for 24 hours as part of post-injection care. | Procedure or surgery | Conventional Group |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: 6 weeks
SPADI: self-reported questionnaire by patient on pain and disability.
QuickDASH score
Time frame: 6 weeks
self-reported questionnaire by patient on upper extremity disability
Pain score
Time frame: 6 weeks
self-reported by patient using visual analogue scale (VAS).
Active and passive range of motions (ROM):
Time frame: 6 weeks
measured by investigators blinded to the treatments.
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 23 May 2025.
- Individual participant dataSharing planned: No. The authors adhered to the consort recommendations for clinical trials. Study Protocol may be shared with other researchers by authors upon request.
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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.
Dr Chew Li Ching principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrodilatation injection and Intra-articular steroid injection (IAI) in people with Adhesive Capsulitis, Shoulder, run by Singapore General Hospital at 1 site in Singapore.
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 23 May 2025. 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 Singapore. 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 (SPADI) (time frame: 6 weeks). The study lists 4 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 23 May 2025.