Shoulder BursitisNCT06220643
Steroid Injection with Exercise for Subacromial Bursitis
A study testing resistance exercise and triamcinolone acetonide plus lidocaine in people with Shoulder Bursitis, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
Shoulder issues in middle-aged and elderly folks often stem from muscle and tendon degeneration, causing pain and limited movement. Current treatments like corticosteroid injections provide short-term relief for synovial bursitis, prompting repetitive injections. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Shoulder Bursitis
- What is being tested?
- resistance exercise and triamcinolone acetonide plus lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 31 Dec 2024
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of subacromial bursitis of shoulder
Who cannot join
- history of shoulder shoulder and operation history
- comorbid with adhesive capsulitis or rotator cuff tear
- received local injection of shoulder with steroid, hypertonic dextrose, hyaluronic acid or platelet-rich plasma in recent 6 months
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, Zhonghe Dist, 235
About this study
Official title: Prognosis and Effects of Ultrasound Guide Corticosteroid Injection with Progressive Resistance Exercise for Subacromial Bursitis: a Randomized Clinical Trial
Shoulder issues in middle-aged and elderly folks often stem from muscle and tendon degeneration, causing pain and limited movement. Current treatments like corticosteroid injections provide short-term relief for synovial bursitis, prompting repetitive injections. Combining these injections with resistance exercises, especially elastic bands, might extend relief. A study aims to test this by giving injections and a 12-week elastic band exercise program to one group, compared to injections alone in another. Assessments at 4, and 12 weeks post-injection will measure pain, motion, and functionality. Successful results could redefine treatment, reducing repetitive injections and enhancing life quality for those with shoulder problems.
Read the detailed description
Shoulder activities are common among middle-aged and elderly individuals, often leading to degeneration of shoulder muscles and tendons. This degeneration causes instability, resulting in shoulder impingement syndrome and subsequent inflammation of the synovial bursa. Acute synovial bursitis leads to severe shoulder pain, limited movement, affecting daily life and work. Initial treatments like physical therapy and oral medication often fall short, necessitating corticosteroid injections into the subacromial bursa guided by ultrasound for effective relief. However, these injections often provide only short-term relief, leading to a need for repeated injections, causing concerns about side effects.
Previous research indicates that resistance-based exercises improve muscle strength and reduce shoulder tissue damage. Among these exercises, elastic band workouts are deemed safest for the elderly. Despite advancements in ultrasound-guided injections for subacromial bursitis, there's a scarcity of studies combining corticosteroid injections with progressive shoulder resistance exercises to prolong therapeutic effects.
This study aims to explore if progressive resistance exercises enhance and sustain the clinical benefits of ultrasound-guided corticosteroid injections in subacromial bursitis. It's a randomized double-single-blind study wherein the experimental group receives ultrasound-guided injections of 40mg triamcinolone acetonide and 2cc lidocaine into the inflamed bursa and undergoes a 12-week course of elastic band progressive resistance exercises. The control group only receives ultrasound-guided injections. Evaluators remain unaware of the group assignments. Parameters like VAS , ROM, and SPADI are assessed at 4, and 12 weeks post-injection.
This research seeks to ascertain whether combining corticosteroid injections with progressive resistance exercises prolongs the efficacy of treatment for subacromial bursitis. If successful, it could offer a novel approach to managing this condition, potentially reducing the need for repeated injections and improving the overall quality of life for middle-aged and elderly individuals affected by shoulder issues.
- Conditions
- Shoulder Bursitis
- Being tested
- resistance exercise, triamcinolone acetonide plus lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance exerciseOther
Progressive resistance exercise for 12 weeks
triamcinolone acetonide plus lidocaineDrug
Also called exercise education
40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%)
| Study group | Role | What they receive |
|---|---|---|
| Echoguide steroid injection without exercise (only education) | Active comparator | received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance Receives: Drug: triamcinolone acetonide plus lidocaine |
| Echoguide steroid injection with exercise | Experimental | experimental group received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance, and a 12-week elastic band progressive resistance exercise Receives: Other: resistance exercise; Drug: triamcinolone acetonide plus lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.
Measured: Day 0, Month 1, Month 3
Visual Analogue Scale (VAS)
pain score from 0~10, 0 means no pain, and 10 means extreme pain
Measured: Day 0, Month 1, Month 3
Secondary outcomes (1)
pain free range of motion
Shoulder range of motion of flexion, extension, abduction, internal rotation, external rotation
Measured: Day 0, Month 1, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
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 Shoulder 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
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ShihWei Huang, Taipei Medical University Shuang Ho Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220643
- Sponsor's protocol ID
- N202306022
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang YC, Yang MT, Cheng YH, Liao CD, Chang KH, Wong PC, Huang SW. Efficacy of a Mobile Health-Supported Home-Based Resistance Exercise After Ultrasound-Guided Corticosteroid Injection in Chronic Subacromial Bursitis: A Randomized Controlled Trial. J Clin Med. 2026 Mar 27;15(7):2567. doi: 10.3390/jcm15072567.
PubMed 41976862
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis and Effects of Ultrasound Guide Corticosteroid Injection with Progressive Resistance Exercise for Subacromial Bursitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06220643
- Acronym / sponsor ID
- N202306022
- Conditions
- Shoulder Bursitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Jan 2024 (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.
Shoulder issues in middle-aged and elderly folks often stem from muscle and tendon degeneration, causing pain and limited movement. Current treatments like corticosteroid injections provide short-term relief for synovial bursitis, prompting repetitive injections. Combining these injections with resistance exercises, especially elastic bands, might extend relief. A study aims to test this by giving injections and a 12-week elastic band exercise program to one group, compared to injections alone in another. Assessments at 4, and 12 weeks post-injection will measure pain, motion, and functionality. Successful results could redefine treatment, reducing repetitive injections and enhancing life quality for those with shoulder problems.
Detailed description
Shoulder activities are common among middle-aged and elderly individuals, often leading to degeneration of shoulder muscles and tendons. This degeneration causes instability, resulting in shoulder impingement syndrome and subsequent inflammation of the synovial bursa. Acute synovial bursitis leads to severe shoulder pain, limited movement, affecting daily life and work. Initial treatments like physical therapy and oral medication often fall short, necessitating corticosteroid injections into the subacromial bursa guided by ultrasound for effective relief. However, these injections often provide only short-term relief, leading to a need for repeated injections, causing concerns about side effects.
Previous research indicates that resistance-based exercises improve muscle strength and reduce shoulder tissue damage. Among these exercises, elastic band workouts are deemed safest for the elderly. Despite advancements in ultrasound-guided injections for subacromial bursitis, there's a scarcity of studies combining corticosteroid injections with progressive shoulder resistance exercises to prolong therapeutic effects.
This study aims to explore if progressive resistance exercises enhance and sustain the clinical benefits of ultrasound-guided corticosteroid injections in subacromial bursitis. It's a randomized double-single-blind study wherein the experimental group receives ultrasound-guided injections of 40mg triamcinolone acetonide and 2cc lidocaine into the inflamed bursa and undergoes a 12-week course of elastic band progressive resistance exercises. The control group only receives ultrasound-guided injections. Evaluators remain unaware of the group assignments. Parameters like VAS , ROM, and SPADI are assessed at 4, and 12 weeks post-injection.
This research seeks to ascertain whether combining corticosteroid injections with progressive resistance exercises prolongs the efficacy of treatment for subacromial bursitis. If successful, it could offer a novel approach to managing this condition, potentially reducing the need for repeated injections and improving the overall quality of life for middle-aged and elderly individuals affected by shoulder issues.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echoguide steroid injection without exercise (only education) | Active comparator | Drug: triamcinolone acetonide plus lidocainereceived 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance |
| Echoguide steroid injection with exercise | Experimental | Other: resistance exercise, Drug: triamcinolone acetonide plus lidocaineexperimental group received 40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) injected into the inflamed subacromial bursa with ultrasound guidance, and a 12-week elastic band progressive resistance exercise |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of subacromial bursitis of shoulder
Key exclusion criteria (3 listed)
- history of shoulder shoulder and operation history
- comorbid with adhesive capsulitis or rotator cuff tear
- received local injection of shoulder with steroid, hypertonic dextrose, hyaluronic acid or platelet-rich plasma in recent 6 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 |
|---|---|---|
| resistance exerciseProgressive resistance exercise for 12 weeks | Other | Echoguide steroid injection with exercise |
| triamcinolone acetonide plus lidocaineAlso: exercise education40mg triamcinolone acetonide 1cc plus 2cc lidocaine (1%) | Drug | Echoguide steroid injection with exercise, Echoguide steroid injection without exercise (only education) |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Day 0, Month 1, Month 3
The Shoulder Pain and Disability Index (SPADI) is a patient completed questionnaire with 13 items assessing pain level and extent of difficulty with ADLs requiring the use of the upper extremities. The pain subscale has 5-items and the Disability subscale has 8-items.
Visual Analogue Scale (VAS)
Time frame: Day 0, Month 1, Month 3
pain score from 0~10, 0 means no pain, and 10 means extreme pain
1 secondary outcome
pain free range of motion
Time frame: Day 0, Month 1, Month 3
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 20 Jan 2025.
- Derived from this study: PubMed 41976862Chang YC, Yang MT, Cheng YH, Liao CD, Chang KH, Wong PC, Huang SW. Efficacy of a Mobile Health-Supported Home-Based Resistance Exercise After Ultrasound-Guided Corticosteroid Injection in Chronic Subacromial Bursitis: A Randomized Controlled Trial. J Clin Med. 2026 Mar 27;15(7):2567. doi: 10.3390/jcm15072567.
- Individual participant dataSharing planned: No
Related trials for Shoulder Bursitis
Active, not recruiting
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OMT for Adhesive Capsulitis
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Spencer's Technique Versus Mulligan's Technique for Stage II Frozen Shoulder
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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.
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 resistance exercise and triamcinolone acetonide plus lidocaine in people with Shoulder Bursitis, run by Taipei Medical University Shuang Ho 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 1 inclusion and 3 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 20 Jan 2025. 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?
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?
Shoulder Pain and Disability Index (SPADI) (time frame: Day 0, Month 1, Month 3). The study lists 2 primary outcomes in all. 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 NCT06220643, 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 20 Jan 2025; AzTrials last refreshed its copy on 28 Oct 2026.