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Not yet recruitingNCT07729514Updated Jul 30, 2026

Effect of Different Hyaluronic Acids in the Treatment of Subdeltoid Bursitis

A Phase 4 interventional study of ultra-high molecular weight hyaluronic acid injection and high molecular weight hyaluronic acid injection in Subdeltoid Bursitis of the Shoulder, sponsored by Shin Kong Wu Ho-Su Memorial Hospital. Not yet recruiting. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Shin Kong Wu Ho-Su Memorial Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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. 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).

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Conditions studied

  • Subdeltoid Bursitis of the Shoulder

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Keywords

  • hyaluronic acid
  • pain
  • subdeltoid bursitis
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In context

Pain

10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.

This study's planned enrollment of 52 is below the median of 66 across 8,493 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital is the lead sponsor of 65 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture

History of

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

Cervical radiculopathy

Diagnosed frozen shoulder (adhesive capsulitis)

Psychiatric disorders

Breastfeeding or pregnant women

Received shoulder injection within the past 3 months, including , hyaluronic acid, -rich plasma, or any prolotherapy solution

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    ultra-high molecular weight hyaluronic acid

    Drug: ultra-high molecular weight hyaluronic acid injection

  • Active comparator
    high molecular weight hyaluronic acid

    Drug: high molecular weight hyaluronic acid injection

Interventions

  • Drugultra-high molecular weight hyaluronic acid injection

    ultra-high molecular weight hyaluronic acid

  • Drughigh molecular weight hyaluronic acid injection

    Ultrasound-guided injection into subdeltoid bursa

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

Secondary outcomes

  1. 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

    Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

  2. Range of motions of shoulder joint

    Range of motion of the shoulder joint

    Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

  3. 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

    Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

  4. 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

    Time frame: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — The data will be available upon request to the investigator

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07729514
Lead sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 30, 2026

Study contacts

Ru-Lan Hsieh, MD
Contact
rulanhsieh@gmail.com
Telephone: 886 + 2-28332211 Ex

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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