Subdeltoid BursitisPhase 4NCT05918146
Dextrose Therapy on Physical Therapy in Subdeltoid Bursitis
A Phase 4 study testing Dextrose and Normal saline in people with Subdeltoid Bursitis and Injection, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Subdeltoid Bursitis, Injection, Effect of Drug
- What is being tested?
- Dextrose and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Jun 2023to 30 Jun 2024
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up
Who cannot join
- history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study
Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.
Read the detailed description
A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.
- Conditions
- Subdeltoid Bursitis, Injection, Effect of Drug
- Being tested
- Dextrose, Normal saline
- Keywords
- subdeltoid bursitis, dextrose, physical therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextroseDrug
Also called physical therapy
Dextrose injection plus physical therapy
Normal salineDrug
Also called physical therapy
Normal saline injection plus physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Dextrose injection, one time Receives: Drug: Dextrose |
| Control group | Placebo comparator | Normal saline injection, one time Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain and disability index
measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability
Measured: score change from baseline to 1 week, 1 month and 3 months after treatment
Secondary outcomes (3)
Disabilities of the arm, shoulder, and hand
measure sports/music and work related to shoulder pain, ranges from 0-100, higher scores indicate more pain or disability
Measured: score change from baseline to 1 week, 1 month and 3 months after treatment
Visual analog scale
measure shoulder pain, ranges from 0-10, higher score indicate more pain
Measured: score change from baseline to 1 week, 1 month and 3 months after treatment
range of motion
measure shoulder range of motion, higher score indicate higher range of motion
Measured: score change from baseline to 1 week, 1 month and 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start20 Jun 2023 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subdeltoid BursitisStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Hsieh, MD, Study chair, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918146
- Sponsor's protocol ID
- 2023SKHADR033
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 27 Jun 2023
- 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 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hypertonic Dextrose Prolotherapy on Conventional Physical Therapy in Patients With Subdeltoid Bursitis: a Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05918146
- Acronym / sponsor ID
- 2023SKHADR033
- Conditions
- Subdeltoid Bursitis, Injection, Effect of Drug
- Keywords
- subdeltoid bursitis, dextrose, physical therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Jun 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.
Physical therapy and hypertonic dextrose prolotherapy are often used to treat subdeltoid bursitis. This study aims to investigate the effects of hypertonic dextrose injection on physical therapy through a double-blind, randomized study.
Detailed description
A double-blind, randomized, placebo-controlled clinical trial will be conducted to collect 44 patients with subdeltoid bursitis. In the first week and the third week, a total of 20% hypertonic dextrose 10 mL (experimental group) and normal saline 10 mL (placebo group) will be injected under sonographic guidance, and physical therapy (hot shoulder pack, interference wave, and exercise for 20 minutes each) 3 times per week for one month will be arranged. Shoulder pain by visual analog scale, function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) and high-resolution ultrasound examination will be arranged at before treatment, one week after treatment (i.e., one week after injection), one month, and three months after injection.
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: DextroseDextrose injection, one time |
| Control group | Placebo comparator | Drug: Normal salineNormal saline injection, one time |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinical diagnosis of subdeltoid bursitis age 20 or older 20 at least one positive in the painful arc, neer test, or Hawkins test can attend 3 months of intervention and follow up
Key exclusion criteria (1 listed)
- history of malignancy previous shoulder operation or injury previous shoulder injections in the past 3 months
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 |
|---|---|---|
| DextroseAlso: physical therapyDextrose injection plus physical therapy | Drug | Intervention group |
| Normal salineAlso: physical therapyNormal saline injection plus physical therapy | Drug | Control group |
Primary outcome
Shoulder pain and disability index
Time frame: score change from baseline to 1 week, 1 month and 3 months after treatment
measure shoulder pain and disability, ranges from 0-100, higher scores indicate more pain or disability
3 secondary outcomes
Disabilities of the arm, shoulder, and hand
Time frame: score change from baseline to 1 week, 1 month and 3 months after treatment
Visual analog scale
Time frame: score change from baseline to 1 week, 1 month and 3 months after treatment
range of motion
Time frame: score change from baseline to 1 week, 1 month and 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ru-Lan Hsieh, MD 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 Phase 4 study testing Dextrose and Normal saline in people with Subdeltoid Bursitis and Injection, run by Taipei Medical University 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 1 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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. Some participants in this study may receive a placebo. 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 Ru-Lan Hsieh, MD (886-2-28332211 ext. 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 month and 3 months after treatment). 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 27 Jun 2023.