Subdeltoid Bursitis of the ShoulderNCT07729527
Effects of Hyaluronic Acid for Subdeltoid Bursitis
A study testing Hyaluronic Acid (HA), 2 ml, single injection in people with Subdeltoid Bursitis of the Shoulder, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: with either cross-linked hyaluronic acid or non-crossed-linked hyaluronic acid injection. All injections are guided by ultrasound. 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 (HA), 2 ml, single injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Jul 2026to 31 Dec 2026
- Phase
- Interventional
- 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 2 weeks 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) 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) 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, 111-20
Ru-Lan Hsieh, MD, 886-2-28332211 ext. 2538, 2531, M001052@ms.skh.org.tw
About this study
Official title: Therapeutic Effects of Hyaluronic Acid in the Treatment of Subdeltoid Bursitis
The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: with either cross-linked hyaluronic acid or non-crossed-linked hyaluronic acid 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, 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 (HA), 2 ml, single injection
- Keywords
- subdeltoid bursitis, hyaluronic acid, pain, function, quality of life
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA), 2 ml, single injectionDevice
hyaluronic acid, 2ml, single injection
| Study group | Role | What they receive |
|---|---|---|
| cross-linked hyaluronic acid | Experimental | cross-linked acid injection Receives: Device: Hyaluronic Acid (HA), 2 ml, single injection |
| Non-crossed linked hyaluronic acid | Active comparator | non-cross-linked hyaluronic acid injection Receives: Device: Hyaluronic Acid (HA), 2 ml, single 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)
Disability 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
Range of motions of shoulder joint
Range of motion of the shoulder joint, from 0 to 160, the higher range of motion, the greater function
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 posted27 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 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 chair, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729527
- Sponsor's protocol ID
- NSTC 114-2314-B-341-005
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not decided.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Hyaluronic Acid in the Treatment of Subdeltoid Bursitis
- ClinicalTrials.gov ID
- NCT07729527
- Acronym / sponsor ID
- NSTC 114-2314-B-341-005
- Conditions
- Subdeltoid Bursitis of the Shoulder
- Keywords
- subdeltoid bursitis, hyaluronic acid, pain, function, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Jul 2026 (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 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: with either cross-linked hyaluronic acid or non-crossed-linked hyaluronic acid 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, 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cross-linked hyaluronic acid | Experimental | Device: Hyaluronic Acid (HA), 2 ml, single injectioncross-linked acid injection |
| Non-crossed linked hyaluronic acid | Active comparator | Device: Hyaluronic Acid (HA), 2 ml, single injectionnon-cross-linked hyaluronic acid injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Unilateral shoulder pain within the past 2 weeks 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) 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
Key exclusion criteria (1 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 Neurological disorders causing hand weakness or affecting shoulder mobility (e.g., stroke, Parkinson's disease, brachial plexus injury, peripheral neuropathy) 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
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 (HA), 2 ml, single injectionhyaluronic acid, 2ml, single injection | Device | Non-crossed linked hyaluronic acid, cross-linked hyaluronic acid |
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
Disability 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
Range of motions of shoulder joint
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 29 Jul 2026.
- Individual participant dataSharing planned: No. Not decided.
Related trials for Subdeltoid Bursitis of the Shoulder
Not yet recruitingPhase 4
Effect of Different Hyaluronic Acids in the Treatment of Subdeltoid Bursitis
Subdeltoid Bursitis of the Shoulder
Not yet recruitingPhase 4
Additional Effect of Steroid on Hyaluronic Acid in Subdeltoid Bursitis
Subdeltoid Bursitis of the Shoulder
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 chair
Shin Kong Wu Ho-Su Memorial 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 Hyaluronic Acid (HA), 2 ml, single injection in people with Subdeltoid Bursitis of the Shoulder, run by Shin Kong Wu Ho-Su Memorial 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?
The sponsor lists 4 inclusion and 1 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 29 Jul 2026. 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?
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 ext. 2538, 2531, 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 29 Jul 2026.