Subdeltoid Bursitis of the ShoulderPhase 4NCT06935877
Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis
A Phase 4 study testing Hyaluronic acid injection and Triamcinolone Acetonide injection in people with Subdeltoid Bursitis of the Shoulder, run by Shin Kong Wu Ho-Su Memorial Hospital.
Trial summary
The study employs a double-blind, randomized clinical trial design with 60 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: the experimental group receives combined hyaluronic acid and Triamcinolone Acetonide injections, while the control group receives hyaluronic acid alone… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Subdeltoid Bursitis of the Shoulder
- What is being tested?
- Hyaluronic acid injection and Triamcinolone Acetonide injection
- 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
- 25 Apr 2025to 30 Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Unilateral shoulder pain within the past 3 months
- Pain during joint movements such as abduction or internal rotation
- At least one positive result from the following tests: Painful arc, Neer test, or Hawkins test
- No shoulder injections received in the past 3 months
- Willingness to receive injection treatment and undergo follow-up assessments at the following time points:
- Immediate (1 week after injection)
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- Short-term (1 month after injection)
- Mid-term (3 months after injection)
- Avoid use of anti-inflammatory painkillers during the study period as much as possible; if intolerable pain occurs, acetaminophen (provided by the researcher) will be used to relieve symptoms
Who cannot join
- Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture
- History of malignancy
- Previous shoulder surgery
- Sensory deficits
- Tendon rupture of the rotator cuff or biceps tendon
- Neurological disorders causing hand weakness or affecting shoulder mobility (e.g., stroke, Parkinson's disease, brachial plexus injury, peripheral neuropathy)
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- Cognitive impairment preventing completion of questionnaires
- Cervical radiculopathy
- Diagnosed frozen shoulder (adhesive capsulitis)
- Psychiatric disorders
- Breastfeeding or pregnant women
- Received shoulder injection within the past 3 months, including corticosteroids, hyaluronic acid, Platelet-rich plasma, or any prolotherapy solution
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of the Efficacy of Combined Hyaluronic Acid and Triamcinolone Acetonide Injection and Hyaluronic Acid Alone Injection in Patients With Subdeltoid Bursitis
The study employs a double-blind, randomized clinical trial design with 60 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: the experimental group receives combined hyaluronic acid and Triamcinolone Acetonide injections, while the control group receives hyaluronic acid alone injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.
Read the detailed description
Evaluation indicators include pain (measured by Visual Analog Scale for rest, activity, and sleep, and pain threshold via pressure algometer), function (assessed by Disabilities of the Arm, Shoulder, and Hand score and Shoulder Pain and Disability Index), quality of life (using the World Health Organization Quality of Life-BREF).
- Conditions
- Subdeltoid Bursitis of the Shoulder
- Being tested
- Hyaluronic acid injection, Triamcinolone Acetonide injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acid injectionDrug
Also called Hyaluronic acid
traditional rehabilitation programs
Triamcinolone Acetonide injectionDrug
Also called Triamcinolone Acetonide
traditional rehabilitation programs
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | traditional rehabilitation programs Receives: Drug: Hyaluronic acid injection; Drug: Triamcinolone Acetonide injection |
| Control | Active comparator | Hyaluronic acid injection Receives: Drug: Hyaluronic acid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index
A questionnaire to evaluate the severity of shoulder pain and disability in patients with shoulder problems; higher scores indicated more significant pain and disability.The score ranges from 0 to 100: 0 = no disability; 100 = most severe disability
Measured: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Secondary outcomes (4)
Disabilities of the Arm, Shoulder, and Hand
The questionnaire to measure physical function and symptoms in people with upper-limb disorders, including conditions affecting the shoulder, elbow, wrist, or hand. The score ranges from 0 to 100: 0 = no disability; 100 = most severe disability
Measured: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Range of motions of shoulder joint
Measured: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
World Health Organization Quality of Life
Assesses 4 key domains: Physical Health, Psychological , Social Relationships and Environment, score ranges 0-100, higher score indicates greater health
Measured: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
visual analog scale
Measuring subjective pain intensity, score ranges from 0 to 10 (or 0 to 100 mm, depending on format), the higher score indicates more severe symptom
Measured: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subdeltoid Bursitis of the ShoulderStudies of the same condition, open and under way.
- 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
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Ru-Lan Hsieh, Study director, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935877
- Sponsor's protocol ID
- 2025SKHADR040
- Status last verified
- Apr 2025
- First submitted
- 10 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- 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 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Combined Hyaluronic Acid and Triamcinolone Acetonide Injection and Hyaluronic Acid Alone Injection in Patients With Subdeltoid Bursitis
- ClinicalTrials.gov ID
- NCT06935877
- Acronym / sponsor ID
- 2025SKHADR040
- Conditions
- Subdeltoid Bursitis of the Shoulder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 20 Apr 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.
The study employs a double-blind, randomized clinical trial design with 60 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: the experimental group receives combined hyaluronic acid and Triamcinolone Acetonide injections, while the control group receives hyaluronic acid alone injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.
Detailed description
Evaluation indicators include pain (measured by Visual Analog Scale for rest, activity, and sleep, and pain threshold via pressure algometer), function (assessed by Disabilities of the Arm, Shoulder, and Hand score and Shoulder Pain and Disability Index), quality of life (using the World Health Organization Quality of Life-BREF).
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 |
|---|---|---|
| Intervention group | Experimental | Drug: Hyaluronic acid injection, Drug: Triamcinolone Acetonide injectiontraditional rehabilitation programs |
| Control | Active comparator | Drug: Hyaluronic acid injectionHyaluronic acid injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- - Unilateral shoulder pain within the past 3 months
- Pain during joint movements such as abduction or internal rotation
- At least one positive result from the following tests: Painful arc, Neer test, or Hawkins test
- No shoulder injections received in the past 3 months
- Willingness to receive injection treatment and undergo follow-up assessments at the following time points:
Key exclusion criteria (12 listed)
- Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture
- History of malignancy
- Previous shoulder surgery
- Sensory deficits
- Tendon rupture of the rotator cuff or biceps tendon
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 |
|---|---|---|
| Hyaluronic acid injectionAlso: Hyaluronic acidtraditional rehabilitation programs | Drug | Control, Intervention group |
| Triamcinolone Acetonide injectionAlso: Triamcinolone Acetonidetraditional rehabilitation programs | Drug | Intervention group |
Primary outcome
Shoulder Pain and Disability Index
Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
A questionnaire to evaluate the severity of shoulder pain and disability in patients with shoulder problems; higher scores indicated more significant pain and disability.The score ranges from 0 to 100: 0 = no disability; 100 = most severe disability
4 secondary outcomes
Disabilities of the Arm, Shoulder, and Hand
Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
World Health Organization Quality of Life
Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
visual analog scale
Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Subdeltoid Bursitis of the Shoulder
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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.
Ru-Lan Hsieh study director
Shin Kong Wu Ho-Su Memorial Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyaluronic acid injection and Triamcinolone Acetonide injection in people with Subdeltoid Bursitis of the Shoulder, run by Shin Kong Wu Ho-Su Memorial Hospital.
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 9 inclusion and 12 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: opening soon, as of the sponsor's last update on 24 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ru-Lan Hsieh, Dr, MD (886 + 2-28332211, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome). 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 24 Apr 2025.