Subacromial BursitisNCT03447158
Effects of Hyperosmolar Dextrose in Rotator Cuff Disorder With Bursitis
A study testing 15% Dextrose and Normal saline in people with Subacromial Bursitis, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis . Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subacromial Bursitis
- What is being tested?
- 15% Dextrose and Normal saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Jul 2018to 23 Jan 2020
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 20-65 years-old
- pain lasting >3 months
- Painful arc between 40° to 120° in abduction
- positive Neer and Hawkins-Kennedy tests
- positive Empty can test
- pain in daily living activities
- Bursa thickness more than 2mm in ultrasound
- Rotator cuff tendinopathy
Who cannot join
- history of significant shoulder trauma
- history of surgery, fracture, or dislocation
- adhesive capsulitis
- full thickness rotator cuff tear
- a long head of bicep tendon tear
- Contra-indications to local dextrose injection (known blood coagulation disorders, warfarin therapy, allergy to dextrose)
Show all 11Show fewer
- previous shoulder steroid injection in one month
- had any rheumatologic, systemic, or neurologic disorders
- patients taking regular systemic NSAIDs or steroids
- pregnant or breastfeeding mothers
- malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial
The main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis .
Read the detailed description
Rotator cuff disorder with bursitis is one of the most frequent pathologies of the shoulder, which may cause serious restriction of daily activities and reduce quality of life. There are many ways in treating rotator cuff disorder with bursitis, including medication, physical therapy, kinesiological taping, acupuncture and local injection. Protholotherapy, which inject hyperosmolar dextrose to soft tissue, is a novel management in musculoskeletal disorders. However, only few trials exist in studying hyperosmolar dextrose injection for rotator cuff disorder with bursitis and most of them have small sample size and not randomized. The aim of this study was to figure out the effects of sonographically guided subacromial bursa injection with hyperosmolar dextrose in rotator cuff disorder with bursitis by a randomized controlled trial.
- Conditions
- Subacromial Bursitis
- Being tested
- 15% Dextrose, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% DextroseProcedure or surgery
inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance
Normal salineProcedure or surgery
inject normal saline and xylocaine into subacrominal bursa under sonographically guidance
| Study group | Role | What they receive |
|---|---|---|
| 15% Dextrose group | Experimental | 4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance Receives: Procedure: 15% Dextrose |
| control group | Placebo comparator | 4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance Receives: Procedure: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
maximal visual analog scale (VAS) in the past week during shoulder activity. Visual analog scale is range from 0-10. The higher score indicated more severe pain.
Measured: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Secondary outcomes (4)
Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy
abduction and flexion
Measured: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy
Shoulder pain and disability questionnaire with two subscales, pain scale and function scale. Pain scale is range from 0-50. The higher scale indicates worse pain outcome. Function scale is range from 0-80. The higher scale indicates poor shoulder function. The total scale is summation of pain scale and function scale.
Measured: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy
Thickness of bursa and elastogram
Measured: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy
maximal visual analog scale (VAS) in the past week during resting. Visual analog scale is range from 0-10. The higher score indicated more severe pain.
Measured: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start18 Jul 2018
- Primary completion25 Sep 2019
- Study completion23 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subacromial BursitisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447158
- Sponsor's protocol ID
- 18MMHIS001
- Status last verified
- Jan 2020
- First submitted
- 14 Feb 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang YJ, Chang FH, Hou PH, Tseng KH, Lin YN. Effects of Hyperosmolar Dextrose Injection in Patients With Rotator Cuff Disease and Bursitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):245-250. doi: 10.1016/j.apmr.2020.08.010. Epub 2020 Sep 11.
PubMed 32926850
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hyperosmolar Dextrose Injection in Rotator Cuff Disorder With Bursitis : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03447158
- Acronym / sponsor ID
- 18MMHIS001
- Conditions
- Subacromial Bursitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 23 Jan 2020 (actual)
- First posted
- 27 Feb 2018 (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 main purpose of this study is to compare treatment efficacy of different concentration dextrose injection in chronic subacromial bursitis .
Detailed description
Rotator cuff disorder with bursitis is one of the most frequent pathologies of the shoulder, which may cause serious restriction of daily activities and reduce quality of life. There are many ways in treating rotator cuff disorder with bursitis, including medication, physical therapy, kinesiological taping, acupuncture and local injection. Protholotherapy, which inject hyperosmolar dextrose to soft tissue, is a novel management in musculoskeletal disorders. However, only few trials exist in studying hyperosmolar dextrose injection for rotator cuff disorder with bursitis and most of them have small sample size and not randomized. The aim of this study was to figure out the effects of sonographically guided subacromial bursa injection with hyperosmolar dextrose in rotator cuff disorder with bursitis by a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 15% Dextrose group | Experimental | Procedure: 15% Dextrose4.5cc 15% dextrose and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance |
| control group | Placebo comparator | Procedure: Normal saline4.5cc normal saline and 0.5cc 1% xylocaine was injected into inflamed subacromial bursa under sonographically guidance |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 20-65 years-old
- pain lasting >3 months
- Painful arc between 40° to 120° in abduction
- positive Neer and Hawkins-Kennedy tests
- positive Empty can test
Key exclusion criteria (11 listed)
- history of significant shoulder trauma
- history of surgery, fracture, or dislocation
- adhesive capsulitis
- full thickness rotator cuff tear
- a long head of bicep tendon tear
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 |
|---|---|---|
| 15% Dextroseinject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance | Procedure or surgery | 15% Dextrose group |
| Normal salineinject normal saline and xylocaine into subacrominal bursa under sonographically guidance | Procedure or surgery | control group |
Primary outcome
Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
maximal visual analog scale (VAS) in the past week during shoulder activity. Visual analog scale is range from 0-10. The higher score indicated more severe pain.
4 secondary outcomes
Change from Baseline shoulder joint active range of motion (PROM) at 1 week, 1 month, and 3 months after 3rd section of therapy
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline Shoulder Pain and Disability Index (SPADI) score at 1 week, 1 month, and 3 months after 3rd section of therapy
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline Ultrasound property at 1 week, 1 month, and 3 months after 3rd section of therapy
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Change from Baseline pain on resting at 1 week, 1 month, and 3 months after 3rd section of therapy
Time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 32926850Chang YJ, Chang FH, Hou PH, Tseng KH, Lin YN. Effects of Hyperosmolar Dextrose Injection in Patients With Rotator Cuff Disease and Bursitis: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2021 Feb;102(2):245-250. doi: 10.1016/j.apmr.2020.08.010. Epub 2020 Sep 11.
Related trials for Subacromial Bursitis
Enrolling by invitation
AI-Assisted Ultrasound Therapy for Adhesive Capsulitis
Adhesive Capsulitis
Recruiting
The Effect of an Exercise Program Based on Attentional Focus Shifting on Clinical Outcomes in Rotator Cuff Related Shoulder Pain
Rotator Cuff Related Shoulder Pain, Subacromial Pain Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15% Dextrose and Normal saline in people with Subacromial Bursitis, run by Mackay 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 8 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: finished, as of the sponsor's last update on 27 Jan 2020. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline pain on activity at 1 week, 1 month, and 3 months after 3rd section of therapy (time frame: before therapy sections, 1 week, 1 month, and 3 months after 3rd section of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03447158, which also lists 1 linked publication.
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 Jan 2020.