Subdeltoid Bursitis of the ShoulderPhase 4NCT07729514
Effect of Different Hyaluronic Acids in the Treatment of Subdeltoid Bursitis
A Phase 4 study testing ultra-high molecular weight hyaluronic acid injection and high molecular weight hyaluronic acid 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 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: ultra-high-molecular-weight hyaluronic acid or high-molecular-weight hyaluronic acid injection. All injections are guided by ultrasound. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subdeltoid Bursitis of the Shoulder
- What is being tested?
- ultra-high molecular weight hyaluronic acid injection and high molecular weight hyaluronic acid injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2027
- 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
- Healthy volunteers accepted
- 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
- 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
- Total 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
Show all 11Show fewer
- 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: Effect of Different Molecular-Weight Hyaluronic Acid in the Treatment of Subdeltoid Bursitis: A Double-Blind Randomized Controlled Trial
The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: ultra-high-molecular-weight hyaluronic acid or high-molecular-weight 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), 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
- ultra-high molecular weight hyaluronic acid injection, high molecular weight hyaluronic acid injection
- Keywords
- hyaluronic acid, pain, subdeltoid bursitis
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-high molecular weight hyaluronic acid injectionDrug
ultra-high molecular weight hyaluronic acid
high molecular weight hyaluronic acid injectionDrug
Ultrasound-guided injection into subdeltoid bursa
| Study group | Role | What they receive |
|---|---|---|
| ultra-high molecular weight hyaluronic acid | Experimental | Not described Receives: Drug: ultra-high molecular weight hyaluronic acid injection |
| high molecular weight hyaluronic acid | Active comparator | Not described Receives: Drug: high molecular weight 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
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 measures 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
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 start1 Aug 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729514
- Sponsor's protocol ID
- 2026SKHADR035
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be available upon request to the investigator
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Molecular-Weight Hyaluronic Acid in the Treatment of Subdeltoid Bursitis: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07729514
- Acronym / sponsor ID
- 2026SKHADR035
- Conditions
- Subdeltoid Bursitis of the Shoulder
- Keywords
- hyaluronic acid, pain, subdeltoid bursitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (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: ultra-high-molecular-weight hyaluronic acid or high-molecular-weight 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), 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 |
|---|---|---|
| ultra-high molecular weight hyaluronic acid | Experimental | Drug: ultra-high molecular weight hyaluronic acid injection |
| high molecular weight hyaluronic acid | Active comparator | Drug: high molecular weight hyaluronic acid injection |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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
Key exclusion criteria (11 listed)
- Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture
- History of malignancy
- Previous shoulder surgery
- Sensory deficits
- Total 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 |
|---|---|---|
| ultra-high molecular weight hyaluronic acid injectionultra-high molecular weight hyaluronic acid | Drug | ultra-high molecular weight hyaluronic acid |
| high molecular weight hyaluronic acid injectionUltrasound-guided injection into subdeltoid bursa | Drug | high molecular weight 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
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
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 30 Jul 2026.
- Individual participant dataSharing planned: No. The data will be available upon request to the investigator
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ultra-high molecular weight hyaluronic acid injection and high molecular weight hyaluronic acid 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 6 inclusion and 11 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 30 Jul 2026. 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, MD (Telephone: 886 + 2-28332211 Ex, rulanhsieh@gmail.com), 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 30 Jul 2026.