Subacromial BursitisNCT03871465
Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis
A study testing Triamcinolone SASD injection, Physiotherapy and Triamcinolone injections & Physiotherapy in people with Subacromial Bursitis and Subacromial Impingement Syndrome, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
Trial summary
This study is to investigate whether combination of ultrasound-guided subdeltoidcorticosteroid injection and physiotherapy is more effective than either treatment alone in treatment of patients with chronic subacromial (or subdeltoid) bursitis (SAB). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Subacromial Bursitis, Subacromial Impingement Syndrome, Physical Therapy
- What is being tested?
- Triamcinolone SASD injection, Physiotherapy and Triamcinolone injections & Physiotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2018to 31 Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- shoulder pain for more than 1 month
- age ≥20 years old
- painful abduction or internal rotation with a visual analog scale (VAS) pain score ≥4
- the presence of a painful arc of motion or pain at the middle to terminal range of shoulder abduction or internal rotation with an empty or soft end feel
- positive shoulder impingement test (Neer test and/or Hawkin test)
- a reduction in pain of ≥40% on active shoulder abduction or internal rotation at the terminal range after injection of 3ml of 1%lidocain into the SASD bursa under US guidance.
Who cannot join
- a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and serious infection
- previous surgery of the affected shoulder
- any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests andsonographic findings
- calcification of the rotator cuff, demonstrated by x-ray or sonographic findings
- the presence of arthritis, such asinflammatory arthritis(e.g., rheumatoid arthritis, seronegativespondyloarthropathy, or crystal-related arthropathy), osteoarthritis, frozen shoulder, subacromial spurs, or deformity of the acromion
- the presence of instability of the affected shoulder
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- a previous fracture near the shoulder region
- the presence of cervical radiculopathy or myelopathy
- having received a corticosteroid or hyaluronic acid subacromial or shoulder joint injection in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
This study is to investigate whether combination of ultrasound-guided subdeltoidcorticosteroid injection and physiotherapy is more effective than either treatment alone in treatment of patients with chronic subacromial (or subdeltoid) bursitis (SAB).
Read the detailed description
Chronic subacromial bursitis (SAB) is a common shoulder disorder characterized by chronic shoulder pain with a painful arc of motion, and/or pain on active or passive motions. The diagnosis of SAB requires confirmation by an infiltration with local anesthetic. Previous study showed that corticosteroid injection is more effective than hyaluronic acid in treatment of chronic SAB, however, some (about 20%) patients were not responsive to corticosteroid injection, and some responsive patients may have recurrence of symptoms. The purpose of this study is to investigate whether combination of corticosteroids SASD injections and physiotherapy is more effective than either treatment alone in chronic SAB.
- Conditions
- Subacromial Bursitis, Subacromial Impingement Syndrome, Physical Therapy, Therapeutic Exercise, Rehabilitation
- Being tested
- Triamcinolone SASD injection, Physiotherapy, Triamcinolone injections & Physiotherapy
- Keywords
- subacromial bursitis, subacromial impingement syndrome, corticosteroid, physical therapy, therapeutic exercise, rehabilitation
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone SASD injectionDrug
2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
PhysiotherapyProcedure or surgery
The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.
Triamcinolone injections & PhysiotherapyDrug
2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.
| Study group | Role | What they receive |
|---|---|---|
| Triamcinolone SASD injection | Experimental | 2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance. Receives: Drug: Triamcinolone SASD injection |
| Physiotherapy | Experimental | The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. Receives: Procedure: Physiotherapy |
| Triamcinolone injections & Physiotherapy | Experimental | 2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. Receives: Drug: Triamcinolone injections & Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pain VAS score
The pain VAS score is obtained using a 100-mm-long horizontal line, with 0 mm on the left indicating no pain and 100 mm on the right indicating very severe pain.
Measured: change between baseline and at 8 weeks after the beginning of the treatment.
The scores of the Shoulder Pain and Disability Index (SPADI)
The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
Measured: change between baseline and at 8 weeks after the beginning of the treatment.
Secondary outcomes (3)
The active ROM
The maximal active ROMs of the affected shoulder will be measured using a goniometer under the guidelines of the American Academy of Orthopedic Surgeons. These measurements included abduction in the frontal plane, forward flexion, internal rotation, and external rotation with the arm at 0 degrees of abduction.
Measured: change between baseline and at 8 weeks after the beginning of the treatment.
Change of the Shoulder Disability Questionnaire (SDQ)
The SDQ is a symptoms-related questionnaire containing 16 items describing common situations that may induce symptoms in patients with shoulder disorders. By responding 'yes', 'no', or 'not applicable', the final score is obtained by dividing the number of positively scored items by the total number of applicable items and then multiplying this number by 100, which results in a final score ranging between 0 (no disability) and 100 (the worst situation).
Measured: change between baseline and at 8 weeks after the beginning of the treatment.
The Western Ontario Rotator Cuff Index (WORC).
It is composed of 5 subscales: physical symptoms, sports/recreation, work, lifestyle, and emotions. Each item has a score range of 0 to 100.Scores can be computed for individual subscales and summated for a total score, which can range from 0-2100, with a higher score representing lower quality of life.
Measured: change between baseline and at 8 weeks after the beginning of the treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Aug 2018
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Lin-Fen Hsieh, Shin Kong Wu Ho-Su Memorial Hospital
- Investigators
- Lin-Fen Hsieh, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871465
- Sponsor's protocol ID
- 20171205R
- Other IDs
- NSTC 107-2314-B-341-002, NSTC 108-2314-B-341-002
- Status last verified
- Nov 2022
- First submitted
- 6 Sep 2018
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Ultrasound-guided Subdeltoid Corticosteroid Injections and Physiotherapy in Treatment of Patients With Chronic Subacromial Bursitis
- ClinicalTrials.gov ID
- NCT03871465
- Acronym / sponsor ID
- 20171205R
- Conditions
- Subacromial Bursitis, Subacromial Impingement Syndrome, Physical Therapy, Therapeutic Exercise, Rehabilitation
- Keywords
- subacromial bursitis, subacromial impingement syndrome, corticosteroid, physical therapy, therapeutic exercise, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 12 Mar 2019 (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.
This study is to investigate whether combination of ultrasound-guided subdeltoidcorticosteroid injection and physiotherapy is more effective than either treatment alone in treatment of patients with chronic subacromial (or subdeltoid) bursitis (SAB).
Detailed description
Chronic subacromial bursitis (SAB) is a common shoulder disorder characterized by chronic shoulder pain with a painful arc of motion, and/or pain on active or passive motions. The diagnosis of SAB requires confirmation by an infiltration with local anesthetic. Previous study showed that corticosteroid injection is more effective than hyaluronic acid in treatment of chronic SAB, however, some (about 20%) patients were not responsive to corticosteroid injection, and some responsive patients may have recurrence of symptoms. The purpose of this study is to investigate whether combination of corticosteroids SASD injections and physiotherapy is more effective than either treatment alone in chronic SAB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Triamcinolone SASD injection | Experimental | Drug: Triamcinolone SASD injection2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance. |
| Physiotherapy | Experimental | Procedure: PhysiotherapyThe physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. |
| Triamcinolone injections & Physiotherapy | Experimental | Drug: Triamcinolone injections & Physiotherapy2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance. The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- shoulder pain for more than 1 month
- age ≥20 years old
- painful abduction or internal rotation with a visual analog scale (VAS) pain score ≥4
- the presence of a painful arc of motion or pain at the middle to terminal range of shoulder abduction or internal rotation with an empty or soft end feel
- positive shoulder impingement test (Neer test and/or Hawkin test)
Key exclusion criteria (9 listed)
- a history of uncontrolled chronic diseases, e.g., malignant neoplasms, blood dyscrasia, and serious infection
- previous surgery of the affected shoulder
- any evidence of a rotator cuff tear or tendinopathy, demonstrated by positive resistive tests andsonographic findings
- calcification of the rotator cuff, demonstrated by x-ray or sonographic findings
- the presence of arthritis, such asinflammatory arthritis(e.g., rheumatoid arthritis, seronegativespondyloarthropathy, or crystal-related arthropathy), osteoarthritis, frozen shoulder, subacromial spurs, or deformity of the acromion
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 |
|---|---|---|
| Triamcinolone SASD injection2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance. | Drug | Triamcinolone SASD injection |
| PhysiotherapyThe physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. | Procedure or surgery | Physiotherapy |
| Triamcinolone injections & Physiotherapy2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance. The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles. | Drug | Triamcinolone injections & Physiotherapy |
Primary outcome
The pain VAS score
Time frame: change between baseline and at 8 weeks after the beginning of the treatment.
The pain VAS score is obtained using a 100-mm-long horizontal line, with 0 mm on the left indicating no pain and 100 mm on the right indicating very severe pain.
The scores of the Shoulder Pain and Disability Index (SPADI)
Time frame: change between baseline and at 8 weeks after the beginning of the treatment.
The total SPADI score, which ranges between 0 and 100, is calculated by averaging the scores from the pain and disabilities subclasses.
3 secondary outcomes
The active ROM
Time frame: change between baseline and at 8 weeks after the beginning of the treatment.
Change of the Shoulder Disability Questionnaire (SDQ)
Time frame: change between baseline and at 8 weeks after the beginning of the treatment.
The Western Ontario Rotator Cuff Index (WORC).
Time frame: change between baseline and at 8 weeks after the beginning of the treatment.
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 17 Nov 2022.
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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.
Lin-Fen Hsieh principal investigator
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 study testing Triamcinolone SASD injection, Physiotherapy and Triamcinolone injections & Physiotherapy in people with Subacromial Bursitis and Subacromial Impingement Syndrome, run by Shin Kong Wu Ho-Su 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 6 inclusion and 9 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 17 Nov 2022. 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?
The pain VAS score (time frame: change between baseline and at 8 weeks after the beginning of the treatment.). 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?
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 17 Nov 2022.