Adhesive Capsulitis of ShoulderPhase 4NCT05977985
The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis.
A Phase 4 study testing Rotator interval hydro-dissection with dextrose 5% and Rotator interval hydro-dissection with corticosteroid solution in people with Adhesive Capsulitis of Shoulder, run by University of Malaya.
Trial summary
Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability. Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with structured physiotherapy (PT) is the current standard of care. 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 of Shoulder
- What is being tested?
- Rotator interval hydro-dissection with dextrose 5% and Rotator interval hydro-dissection with corticosteroid solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 1 Jul 2025
- Phase
- Phase 4
- 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
- patients with primary adhesive capsulitis
- aged 35 to 65 years of age
- duration of symptoms in between 3 to 18 months
- limitation in flexion, abduction, and external rotation greater than 30 degrees compared to normal
- limitation in internal rotation with hand to back shoulder test below L4
Who cannot join
- diagnosis of connective tissue disease or inflammatory arthritis
- history of surgery to the affected shoulder
- history of shoulder dislocation/ fracture
- neurological weakness of the affected upper limb
- ultrasound findings of rotator cuff or LHBT tendinopathy
- plain radiographs showing significant glenohumeral joint osteoarthritis (Kallgren-Lawrence grade 3 or 4)
Show all 10Show fewer
- other sources of chronic pain
- bilateral adhesive capsulitis
- history of pain intervention to the shoulder joint in the past 3 months
- allergic reaction to local anesthetic agent
Trial locations and contacts
No sites are listed yet.
Richard Teo contact
About this study
Official title: The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial
Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability. Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with structured physiotherapy (PT) is the current standard of care. More recent randomized controlled trials have found that rotator interval (RI) hydro-dissection approach leads to better improvement in pain as compared to IA approach. Despite being non-inferior to surgical management, long-term outcome studies of patients treated with IA CS injection and PT have shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean symptom duration of 41.8 months. Furthermore, CS injections are associated with significant systemic and local adverse effects such as Cushing syndrome, osteopenia/ osteoporosis, infection, and hyperglycemia. In recent years, dextrose injection has emerged as an effective alternative to CS-based injections to treat chronic painful musculoskeletal conditions such as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis.
The investigators aim to study the effects of RI hydro-dissection with dextrose 5% (D5%) on pain relief, shoulder ROM and shoulder function in patients with primary AC.
- Conditions
- Adhesive Capsulitis of Shoulder
- Being tested
- Rotator interval hydro-dissection with dextrose 5%, Rotator interval hydro-dissection with corticosteroid solution
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotator interval hydro-dissection with dextrose 5%Drug
Single injection of 20ml dextrose 5% into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe
Rotator interval hydro-dissection with corticosteroid solutionDrug
Single injection of 20ml corticosteroid solution (1 ml triamcinolone 40 mg/ml + 19 ml saline 0.9%) into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe
| Study group | Role | What they receive |
|---|---|---|
| Dextrose 5% | Experimental | Rotator interval hydro-dissection with dextrose 5% solution Receives: Drug: Rotator interval hydro-dissection with dextrose 5% |
| Corticosteroid | Active comparator | Rotator interval hydro-dissection with corticosteroid solution Receives: Drug: Rotator interval hydro-dissection with corticosteroid solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain
Shoulder pain based on Shoulder Pain and Disability Index (SPADI) pain scale. The SPADI pain scale ranges from 0 to 50, with higher score indicating greater level of pain.
Measured: 1 week, 4 weeks and 12 weeks post injection
Secondary outcomes (2)
Shoulder range of motion
Shoulder range of motion in flexion, abduction, external rotation, internal rotation
Measured: 4 weeks and 12 weeks post injection
Shoulder function
Shoulder function based on Shoulder Pain and Disability Index (SPADI) disability scale. The SPADI disability scale ranges from 0 to 80, with higher score indicating greater level of disability.
Measured: 4 weeks and 12 weeks post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of ShoulderStudies of the same condition, open and under way.
- More trials run by University of MalayaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977985
- Sponsor's protocol ID
- 2023630-12612
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Rotator Interval Hydro-dissection in Primary Adhesive Capsulitis. A Two-arm Double-blind Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05977985
- Acronym / sponsor ID
- 2023630-12612
- Conditions
- Adhesive Capsulitis of Shoulder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 7 Aug 2023 (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.
Adhesive capsulitis (AC) is a significant cause of chronic shoulder pain and disability. Non-surgical option consisting of intraarticular corticosteroid (IA CS) injection with structured physiotherapy (PT) is the current standard of care. More recent randomized controlled trials have found that rotator interval (RI) hydro-dissection approach leads to better improvement in pain as compared to IA approach. Despite being non-inferior to surgical management, long-term outcome studies of patients treated with IA CS injection and PT have shown that patients only achieve satisfactory outcomes in 72.3% of patients after a mean symptom duration of 41.8 months. Furthermore, CS injections are associated with significant systemic and local adverse effects such as Cushing syndrome, osteopenia/ osteoporosis, infection, and hyperglycemia. In recent years, dextrose injection has emerged as an effective alternative to CS-based injections to treat chronic painful musculoskeletal conditions such as chronic low back pain, peripheral nerve entrapment and lateral epicondylitis.
The investigators aim to study the effects of RI hydro-dissection with dextrose 5% (D5%) on pain relief, shoulder ROM and shoulder function in patients with primary AC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose 5% | Experimental | Drug: Rotator interval hydro-dissection with dextrose 5%Rotator interval hydro-dissection with dextrose 5% solution |
| Corticosteroid | Active comparator | Drug: Rotator interval hydro-dissection with corticosteroid solutionRotator interval hydro-dissection with corticosteroid solution |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with primary adhesive capsulitis
- aged 35 to 65 years of age
- duration of symptoms in between 3 to 18 months
- limitation in flexion, abduction, and external rotation greater than 30 degrees compared to normal
- limitation in internal rotation with hand to back shoulder test below L4
Key exclusion criteria (10 listed)
- diagnosis of connective tissue disease or inflammatory arthritis
- history of surgery to the affected shoulder
- history of shoulder dislocation/ fracture
- neurological weakness of the affected upper limb
- ultrasound findings of rotator cuff or LHBT tendinopathy
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 |
|---|---|---|
| Rotator interval hydro-dissection with dextrose 5%Single injection of 20ml dextrose 5% into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe | Drug | Dextrose 5% |
| Rotator interval hydro-dissection with corticosteroid solutionSingle injection of 20ml corticosteroid solution (1 ml triamcinolone 40 mg/ml + 19 ml saline 0.9%) into the rotator interval around the long head biceps tendon under ultrasound guidance using a 11-14 Hz frequency linear probe | Drug | Corticosteroid |
Primary outcome
Shoulder pain
Time frame: 1 week, 4 weeks and 12 weeks post injection
Shoulder pain based on Shoulder Pain and Disability Index (SPADI) pain scale. The SPADI pain scale ranges from 0 to 50, with higher score indicating greater level of pain.
2 secondary outcomes
Shoulder range of motion
Time frame: 4 weeks and 12 weeks post injection
Shoulder function
Time frame: 4 weeks and 12 weeks post injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
Related trials for Adhesive Capsulitis of Shoulder
Not yet recruiting
Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
Adhesive Capsulitis
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
Frozen Shoulder, Adhesive Capsulitis
Not yet recruiting
Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
Active, not recruiting
Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
Idiopathic Adhesive Capsulitis
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.
Richard Teo contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rotator interval hydro-dissection with dextrose 5% and Rotator interval hydro-dissection with corticosteroid solution in people with Adhesive Capsulitis of Shoulder, run by University of Malaya.
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 5 inclusion and 10 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 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Richard Teo (richardskteo@ummc.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder pain (time frame: 1 week, 4 weeks and 12 weeks post injection). 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 7 Aug 2023.