Frozen ShoulderPhase 2CUSIS-FS-PilotNCT06626568
Comparison of Ultrasound-Guided Subacromial vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study
A Phase 2 study testing Compound betamethasone Injection(Gluteal muscle injection), Compound betamethasone Injection(Subacromial Ultrasound Guided injection) and home exercise in people with Frozen Shoulder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites in China.
Trial summary
The goal of this multicenter pilot study is to validate the effectiveness of extending the injection interval between betamethasone doses from one to two weeks for treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 75. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Compound betamethasone Injection(Gluteal muscle injection), Compound betamethasone Injection(Subacromial Ultrasound Guided injection) and home exercise
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 9 sitesChina
- Study dates
- 15 Oct 2024to 2 Sep 2025
- Phase
- Phase 2
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of ≤9 months, clinically diagnosed with primary frozen shoulder (including frozen shoulder associated with diabetes).
- Aged between 18 and 75 years old
- Pain NRS score ≥4
- Measured passive range of motion of the affected shoulder in at least two of the three directions (forward flexion, external rotation with arm at the side, and internal rotation with arm at the side) is reduced by 25% or more compared to the contralateral normal shoulder.
- Exclusion of osteoarthritis, dislocation, and other shoulder abnormalities through X-ray and MRI of the affected shoulder.
Who cannot join
- Secondary frozen shoulder caused by thyroid disease, cardiovascular disease, cancer, stroke, radiotherapy, neurosurgery, or breast surgery (excluding diabetes); secondary frozen shoulder caused by major shoulder trauma requiring medical care (e.g., fractures, dislocations, rotator cuff tears).
- Full-thickness rotator cuff tear in the affected shoulder confirmed by MRI (excluding rotator cuff tendinopathy and partial-thickness rotator cuff tear in patients with frozen shoulder without a history of major shoulder trauma).
- Patients unable to undergo MRI due to financial reasons, claustrophobia, pacemaker, or other metallic implants in the body.
- Local infection in the affected shoulder or other contraindications to shoulder injections.
- Patients with contraindications to steroid therapy (e.g., poorly controlled blood sugar in diabetes).
- Patients with frozen shoulder who have already undergone shoulder injections, manipulation under anesthesia, arthroscopic capsular release, or open surgery for capsular release.
Show all 13Show fewer
- Received any form of steroid treatment within the past 3 months.
- History of glucocorticoid use for more than 3 months.
- Bilateral frozen shoulder or a history of frozen shoulder in the contralateral shoulder.
- Pregnant or breastfeeding women.
- Patients lacking the cognitive ability to comply with the study protocol.
- Patients not residing in the area where the study is being conducted.
- Patients with compensation claims or legal disputes related to workplace injury or car accidents.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
The First People's Hospital of Linping District, Hangzhou
Hangzhou, Zhejiang, 311199
Huzhou Central Hospital
Huzhou, Zhejiang, 313000
Pujiang People's Hospital
Jinhua, Zhejiang, 322200
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315020
Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group
Ningbo, Zhejiang, 315799
Yangpu District Central Hospital of Shanghai
Shanghai, Shanghai Municipality, 200082
Shengzhou People's Hospital
Shanhu, Zhejiang, 312400
Guangde County People's Hospital
Xuancheng, Anhui, 242299
About this study
Official title: Comparison Between Ultrasound Guided Subacromial and Systemic Injection of Steroid for Frozen Shoulder: a Double Blind Multicenter Pilot Study for Randomized Control Trial
The goal of this multicenter pilot study is to validate the effectiveness of extending the injection interval between betamethasone doses from one to two weeks for treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 75. This study also aims to screen potential study centers and gather data to refine the sample size calculation for a larger, future trial. The main questions it aims to answer are:
- Does extending the interval between injections maintain effectiveness in improving shoulder function and reducing pain for frozen shoulder?
- Which centers in this pilot study are qualified for a larger, future trial?
- What is the appropriate sample size for conducting a multicenter RCT study with the same research design at the selected centers?
Read more
Participants will:
- Receive 3 injections over 4 weeks and will be followed up for another 8 weeks
- Complete shoulder function assessments
- Perform home rehabilitation exercises
- Conditions
- Frozen Shoulder
- Being tested
- Compound betamethasone Injection(Gluteal muscle injection), Compound betamethasone Injection(Subacromial Ultrasound Guided injection), Normal Saline as Placebo (ultrasound-guided subacromial injection), Normal Saline as Placebo (gluteal muscle inection), home exercise
- Keywords
- frozen shoulder, intramuscular injection, subacromial injection, compound betamethasone, ultrasound guidance
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compound betamethasone Injection(Gluteal muscle injection)Drug
gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4
Compound betamethasone Injection(Subacromial Ultrasound Guided injection)Drug
ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.
Normal Saline as Placebo (ultrasound-guided subacromial injection)Other
ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
Normal Saline as Placebo (gluteal muscle inection)Other
gluteal injection of 5 ml normal saline at week 0,2,4.
home exerciseBehavioural
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| gluteal injection | Experimental | gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4, ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session. Receives: Drug: Compound betamethasone Injection(Gluteal muscle injection); Other: Normal Saline as Placebo (ultrasound-guided subacromial injection); Behavioral: home exercise |
| subacromial injection | Active comparator | gluteal injection of 5 ml normal saline at week 0,2,4, ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4.
The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session. Receives: Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection); Other: Normal Saline as Placebo (gluteal muscle inection); Behavioral: home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
The SPADI score ranges from 0 to 100. A score of 0 indicates no pain or disability, while a score of 100 reflects the worst possible pain and maximum functional disability in the shoulder.
Data entry will be performed by blinded research staff. They will present the paper CRF sample form to the participants and ask questions one by one, directly entering the responses of participants into the corresponding electronic CRF form in the EDC system using handheld electronic devices (such as smartphones, tablets, or laptops).
Measured: Baseline and 12 weeks
Secondary outcomes (21)
progression rate of rotator cuff tears
Third-party experts will conduct blinded readings of shoulder MRI scans, classifying rotator cuff status into three grades: Grade I (intact), Grade II (partial tear), and Grade III (complete tear). Patients classified as Grade III at week 0 will be excluded from the study, as baseline grading (determined by each research center) assesses eligibility per exclusion criterion 2. The lead center provided MRI reading training to all centers, using T2-weighted images with a pure white fluid signal occupying full or partial thickness of the rotator cuff across at least two consecutive MRI slices as the diagnostic criterion for full- or partial-thickness tears. Patients with Grade I or II tears at week 0 will receive study treatment and be followed up at week 12. Tear progression is defined as an increase of at least one grade between weeks 0 and 12, assessed by blinded experts. The progression rate is the number of subjects with progression divided by the total number in each group.
Measured: From enrollment to the end of follow-up at 12 weeks
short version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH）
The QuickDASH score ranges from 0 to 100. A score of 0 means no disability, and a score of 100 signifies the highest level of disability related to arm, shoulder, and hand function.
Data entry will be performed by blinded research staff. They will present the paper CRF sample form to the participants and ask questions one by one, directly entering the responses of participants into the corresponding electronic CRF form in the EDC system using handheld electronic devices (such as smartphones, tablets, or laptops).
Measured: Baseline and 12 weeks
Numerical Rating Scale (NRS)
The NRS score ranges from 0 to 10. A score of 0 indicates no pain, while a score of 10 reflects the worst possible pain.
Data entry will be performed by blinded research staff. They will present the paper CRF sample form to the participants and ask questions one by one, directly entering the responses of participants into the corresponding electronic CRF form in the EDC system using handheld electronic devices (such as smartphones, tablets, or laptops).
Measured: Baseline and 12 weeks
five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
The EQ-5D-5L provides an overall health utility score ranging from -0.281 to 1, where 1 represents perfect health, zero represents a state equivalent to death, and negative values indicate health states worse than death.
It also reports on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each rated on five levels from no problems to extreme problems.
Data entry will be performed by blinded research staff. They will present the paper CRF sample form to the participants and ask questions one by one, directly entering the responses of participants into the corresponding electronic CRF form in the EDC system using handheld electronic devices (such as smartphones, tablets, or laptops).
Measured: Baseline and 12 weeks
passive range of motion of shoulder
The passive range of motion for shoulder flexion, abduction, internal rotation (at the side), and external rotation (at the side) on the affected side will be measured using a goniometer by trained researchers following a pre-established standard operating procedure.
Measured: Baseline and 12 weeks
Direct Medical Cost
The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the onset of frozen shoulder.
Measured: Baseline
Direct Medical Cost
The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the last outpatient research follow-up.
Measured: Baseline and week2
Direct Medical Cost
The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the last outpatient research follow-up.
Measured: Week2 and week4
Direct Medical Cost
The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the last outpatient research follow-up.
Measured: Week4 and week8
Direct Medical Cost
The costs of healthcare resources used for the diagnosis and treatment of frozen shoulder of the participant, including medication fees, medical expenses, testing fees, nursing fees and hospitalization costs. The questionnaire surveys the cost by the participant since the last outpatient research follow-up.
Measured: Week8 and week12
work absenteeism
The questionnaire surveys the number of workdays missed since the onset of frozen shoulder is collected at baseline.
Measured: Week 0
work absenteeism
The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.
Measured: Week 0 and Week 2
work absenteeism
The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.
Measured: Week 2 and Week 4
work absenteeism
The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.
Measured: Week 4 and Week 8
work absenteeism
The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.
Measured: Week 8 and Week 12
Unplanned concomitant use of analgesics
This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up.
Measured: Week 2
Unplanned concomitant use of analgesics
This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up.
Measured: Week 4
Unplanned concomitant use of analgesics
This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up.
Measured: Week 8
Unplanned concomitant use of analgesics
This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up.
Measured: Week 12
Glycated Hemoglobin (HbA1c)
Depending on the specific assay methods used by the laboratory departments of different study centers, HbA1c will be measured by high-Performance Liquid Chromatography (HPLC), Immunoturbidimetric Method, Enzymatic Method, Affinity Chromatography, Electrophoresis, Capillary Electrophoresis or Ion-Exchange Chromatography.
Measured: week 0 and week 12
glycated albumin
Depending on the specific assay methods used by the laboratory departments of different study centers, glycated albumin will be measured by Enzymatic Method, Immunoturbidimetric Method, High-Performance Liquid Chromatography (HPLC), Affinity Chromatography, or Immunoelectrophoresis.
Measured: week 0 and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start15 Oct 2024
- Primary completion21 Aug 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Han, Medical Doctor, Principal investigator, The 2nd Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626568
- Sponsor's protocol ID
- 2024-0405
- Acronym
- CUSIS-FS-Pilot
- Status last verified
- Sep 2024
- First submitted
- 29 Sep 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The current registration is for a pilot study for a later larger trial. We will consider sharing the data after the completion of the subsequent full trial.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Subacromial and Systemic Injection of Steroid for Frozen Shoulder: a Double Blind Multicenter Pilot Study for Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06626568
- Acronym / sponsor ID
- CUSIS-FS-Pilot / 2024-0405
- Conditions
- Frozen Shoulder
- Keywords
- frozen shoulder, intramuscular injection, subacromial injection, compound betamethasone, ultrasound guidance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 4 Oct 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.
The goal of this multicenter pilot study is to validate the effectiveness of extending the injection interval between betamethasone doses from one to two weeks for treating frozen shoulder (adhesive capsulitis) in adults aged 18 to 75. This study also aims to screen potential study centers and gather data to refine the sample size calculation for a larger, future trial. The main questions it aims to answer are:
- Does extending the interval between injections maintain effectiveness in improving shoulder function and reducing pain for frozen shoulder?
- Which centers in this pilot study are qualified for a larger, future trial?
- What is the appropriate sample size for conducting a multicenter RCT study with the same research design at the selected centers?
Participants will:
- Receive 3 injections over 4 weeks and will be followed up for another 8 weeks
- Complete shoulder function assessments
- Perform home rehabilitation exercises
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gluteal injection | Experimental | Drug: Compound betamethasone Injection(Gluteal muscle injection), Other: Normal Saline as Placebo (ultrasound-guided subacromial injection), Behavioral: home exercisegluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4, ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4. The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session. |
| subacromial injection | Active comparator | Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection), Other: Normal Saline as Placebo (gluteal muscle inection), Behavioral: home exercisegluteal injection of 5 ml normal saline at week 0,2,4, ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4. The participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of ≤9 months, clinically diagnosed with primary frozen shoulder (including frozen shoulder associated with diabetes).
- Aged between 18 and 75 years old
- Pain NRS score ≥4
- Measured passive range of motion of the affected shoulder in at least two of the three directions (forward flexion, external rotation with arm at the side, and internal rotation with arm at the side) is reduced by 25% or more compared to the contralateral normal shoulder.
- Exclusion of osteoarthritis, dislocation, and other shoulder abnormalities through X-ray and MRI of the affected shoulder.
Key exclusion criteria (13 listed)
- Secondary frozen shoulder caused by thyroid disease, cardiovascular disease, cancer, stroke, radiotherapy, neurosurgery, or breast surgery (excluding diabetes); secondary frozen shoulder caused by major shoulder trauma requiring medical care (e.g., fractures, dislocations, rotator cuff tears).
- Full-thickness rotator cuff tear in the affected shoulder confirmed by MRI (excluding rotator cuff tendinopathy and partial-thickness rotator cuff tear in patients with frozen shoulder without a history of major shoulder trauma).
- Patients unable to undergo MRI due to financial reasons, claustrophobia, pacemaker, or other metallic implants in the body.
- Local infection in the affected shoulder or other contraindications to shoulder injections.
- Patients with contraindications to steroid therapy (e.g., poorly controlled blood sugar in diabetes).
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 |
|---|---|---|
| Compound betamethasone Injection(Gluteal muscle injection)gluteal injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4 | Drug | gluteal injection |
| Compound betamethasone Injection(Subacromial Ultrasound Guided injection)ultrasound-guided subacromial injection of 1 ml of Compound betamethasone and 4 ml of normal saline at week 0,2,4. | Drug | subacromial injection |
| Normal Saline as Placebo (ultrasound-guided subacromial injection)ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4. | Other | gluteal injection |
| Normal Saline as Placebo (gluteal muscle inection)gluteal injection of 5 ml normal saline at week 0,2,4. | Other | subacromial injection |
| home exerciseThe participants were instructed to perform home rehabilitation exercise for 12 weeks. 30 minutes of home-based self-rehabilitation exercises in the morning, afternoon, and evening, with a total of 90 minutes per day. Standard instructional videos and demonstrations by outpatient rehabilitation therapists are provided to participants. Each exercise, including wall-climbing, table-climbing, and back-climbing, should be performed for 10 minutes, with a total of 30 minutes per session. | Behavioural | gluteal injection, subacromial injection |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline and 12 weeks
The SPADI score ranges from 0 to 100. A score of 0 indicates no pain or disability, while a score of 100 reflects the worst possible pain and maximum functional disability in the shoulder. Data entry will be performed by blinded research staff. They will present the paper CRF sample form to the participants and ask questions one by one, directly entering the responses of participants into the corresponding electronic CRF form in the EDC system using handheld electronic devices (such as smartphones, tablets, or laptops).
21 secondary outcomes
progression rate of rotator cuff tears
Time frame: From enrollment to the end of follow-up at 12 weeks
short version of Disabilities of the Arm, Shoulder, and Hand Questionnaire (QuickDASH）
Time frame: Baseline and 12 weeks
Numerical Rating Scale (NRS)
Time frame: Baseline and 12 weeks
five-level EuroQol five-dimensional questionnaire (EQ-5D-5L)
Time frame: Baseline and 12 weeks
passive range of motion of shoulder
Time frame: Baseline and 12 weeks
Direct Medical Cost
Time frame: Baseline
Direct Medical Cost
Time frame: Baseline and week2
Direct Medical Cost
Time frame: Week2 and week4
Direct Medical Cost
Time frame: Week4 and week8
Direct Medical Cost
Time frame: Week8 and week12
work absenteeism
Time frame: Week 0
work absenteeism
Time frame: Week 0 and Week 2
work absenteeism
Time frame: Week 2 and Week 4
work absenteeism
Time frame: Week 4 and Week 8
work absenteeism
Time frame: Week 8 and Week 12
Unplanned concomitant use of analgesics
Time frame: Week 2
Unplanned concomitant use of analgesics
Time frame: Week 4
Unplanned concomitant use of analgesics
Time frame: Week 8
Unplanned concomitant use of analgesics
Time frame: Week 12
Glycated Hemoglobin (HbA1c)
Time frame: week 0 and week 12
glycated albumin
Time frame: week 0 and week 4
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 7 Jul 2026.
- Individual participant dataSharing planned: Yes. The current registration is for a pilot study for a later larger trial. We will consider sharing the data after the completion of the subsequent full trial.
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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.
Bin Han, Medical Doctor principal investigator
The 2nd Affiliated Hospital of Zhejiang University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Compound betamethasone Injection(Gluteal muscle injection), Compound betamethasone Injection(Subacromial Ultrasound Guided injection) and home exercise in people with Frozen Shoulder, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 9 sites in China.
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 5 inclusion and 13 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: Baseline and 12 weeks). 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 7 Jul 2026.