Frozen ShoulderPhase 4NCT04931511
Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder
A Phase 4 study testing Compound betamethasone Injection(Gluteal muscle injection), Compound betamethasone Injection(Subacromial Ultrasound Guided injection) and Physical therapy in people with Frozen Shoulder and Shoulder Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aim to compare the efficacy of guteal muscle injection and subacromial ultrasound guided injection to treat frozen shoulder. Firstly, in order to calculate the sample size correctly, we start the preliminary study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Frozen Shoulder, Shoulder Pain, Bursitis
- What is being tested?
- Compound betamethasone Injection(Gluteal muscle injection), Compound betamethasone Injection(Subacromial Ultrasound Guided injection) and Physical therapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2021to 1 Sep 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Primary frozen shoulder
- 2. Older than 18 years of age and less than 75 years of age
- 3. The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS
- 4. The passive activity of the side shoulder joint in at least 2 directions in the three directions of front, internal and outer rotation decreased by more than 30 degrees compared to the side shoulder joint or the normal reference value
- 5. corticosteroid injections were not given within 3 months of visit
Who cannot join
- 1. A history of trauma, osteoarthritis, tumors, etc.
- 2. Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed
- 3. There is a history of corticosteroid injections within 3 months of visit
- 4. Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection
- 5. Both side shoulder joints become ill at the same time
- 6. The patient has not signed an informed consent form
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hanzhou, Zhejiang, 310000
About this study
Official title: Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study
This study aim to compare the efficacy of guteal muscle injection and subacromial ultrasound guided injection to treat frozen shoulder. Firstly, in order to calculate the sample size correctly, we start the preliminary study. Besides, in order to propose clinical new technology which combines the advantages of the two therapies, improve the efficacy ratio of frozen shoulder therapy, and provide a frozen shoulder treatment plan according to health economics.
Read the detailed description
In recent years, there have been studies suggesting that small doses of corticosteroid systemic medication and joint local injection to treat shoulder sleeve disease is equivalent, frozen shoulder is clinically in addition to shoulder sleeve disease another common cause of shoulder pain disease, local injection of small dose of corticosteroid is a clinically commonly used treatment of frozen shoulder mature therapy, however, because of the risk of joint infection and other serious complications, and it's personnel experience depended and high qualification requirements, resulting in higher treatment costs. However, it has not been widely used in clinical applications and is generally used as a second-line therapy for the treatment of frozen shoulders. There are studies suggesting that joint cavity hormone injection may be mainly effective through its systemic effect, however, there is currently no random blind control study comparing small doses of hormone systemic injection with local injection of shoulder joints to freeze shoulder, if the equivalence of the two can be confirmed through such studies will greatly change the clinical treatment of frozen shoulders, with hip injection and other systemic medication will provide great health economic advantages, and can avoid the inherent risk of joint cavity injection, reduce the social cost of frozen shoulder treatment.
- Conditions
- Frozen Shoulder, Shoulder Pain, Bursitis
- Being tested
- Compound betamethasone Injection(Gluteal muscle injection), Compound betamethasone Injection(Subacromial Ultrasound Guided injection), Physical therapy
- Medical subject headings
- Bursitis, Shoulder Pain
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
Also called corticosteroid
Gluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml)
Compound betamethasone Injection(Subacromial Ultrasound Guided injection)Drug
Also called corticosteroid
Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)
Physical therapyBehavioural
paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home
| Study group | Role | What they receive |
|---|---|---|
| Gluteal muscle injection plus physical therapy group | Experimental | Gluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy Receives: Drug: Compound betamethasone Injection(Gluteal muscle injection); Behavioral: Physical therapy |
| Subacromial Ultrasound Guided injection plus physical therapy group | Experimental | Gluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy Receives: Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection); Behavioral: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change of Shoulder Pain and Disability Index (SPADI)
The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
Measured: 0,1,2,4,8,12 weeks
Secondary outcomes (5)
The Change of Numeric Rating Scale for Pain (NRS) (Score: 0-10)
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line. Similar to the pain VAS, the NRS is anchored by terms describing pain severity extremes
Measured: 0,1,2,4,8,12 weeks
Anterior flexion of shoulder joint (0-180°)
Passive activity of the shoulder joint
Measured: 0,1,2,4,8,12 weeks
shoulder joint abduction (0-180°)
Passive activity of the shoulder joint
Measured: 0,1,2,4,8,12 weeks
shoulder internal rotator (1-18 score)
The thumb tip reaches the highest point of the back cone:Score1-12: T1-T12; Score13-17:L1-L5;18: below the sacrum;
Measured: 0,1,2,4,8,12 weeks
shoulder external rotator (0-180°)
Passive activity of the shoulder joint
Measured: 0,1,2,4,8,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Why it stopped: Since the COVID-19 pendemic, the regular follow-up of participant became very hard. The participant were not willing to go back to the hospital for repeat measurement. So we stop the study and plan to redesign the protocol.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, huang pintong, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Pintong Huang, Principal investigator, Department of Ultrasound in Medicine, The Second Affiliated AHospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931511
- Sponsor's protocol ID
- Study 2020-1064
- Status last verified
- Dec 2023
- First submitted
- 8 Apr 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I'd like to share the IPD with the other researchers after the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder: a Randomized Double Blind Study
- ClinicalTrials.gov ID
- NCT04931511
- Acronym / sponsor ID
- Study 2020-1064
- Conditions
- Frozen Shoulder, Shoulder Pain, Bursitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Since the COVID-19 pendemic, the regular follow-up of participant became very hard. The participant were not willing to go back to the hospital for repeat measurement. So we stop the study and plan to redesign the protocol.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 18 Jun 2021 (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 aim to compare the efficacy of guteal muscle injection and subacromial ultrasound guided injection to treat frozen shoulder. Firstly, in order to calculate the sample size correctly, we start the preliminary study. Besides, in order to propose clinical new technology which combines the advantages of the two therapies, improve the efficacy ratio of frozen shoulder therapy, and provide a frozen shoulder treatment plan according to health economics.
Detailed description
In recent years, there have been studies suggesting that small doses of corticosteroid systemic medication and joint local injection to treat shoulder sleeve disease is equivalent, frozen shoulder is clinically in addition to shoulder sleeve disease another common cause of shoulder pain disease, local injection of small dose of corticosteroid is a clinically commonly used treatment of frozen shoulder mature therapy, however, because of the risk of joint infection and other serious complications, and it's personnel experience depended and high qualification requirements, resulting in higher treatment costs. However, it has not been widely used in clinical applications and is generally used as a second-line therapy for the treatment of frozen shoulders. There are studies suggesting that joint cavity hormone injection may be mainly effective through its systemic effect, however, there is currently no random blind control study comparing small doses of hormone systemic injection with local injection of shoulder joints to freeze shoulder, if the equivalence of the two can be confirmed through such studies will greatly change the clinical treatment of frozen shoulders, with hip injection and other systemic medication will provide great health economic advantages, and can avoid the inherent risk of joint cavity injection, reduce the social cost of frozen shoulder treatment.
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 muscle injection plus physical therapy group | Experimental | Drug: Compound betamethasone Injection(Gluteal muscle injection), Behavioral: Physical therapyGluteal muscle injection (corticosteroid 1ml+normal saline 4ml) + Subacromial Ultrasound Guided injection (sodium chloride 5ml) + Physical therapy |
| Subacromial Ultrasound Guided injection plus physical therapy group | Experimental | Drug: Compound betamethasone Injection(Subacromial Ultrasound Guided injection), Behavioral: Physical therapyGluteal muscle injection(sodium chloride 5ml)) + Subacromial Ultrasound Guided injection(corticosteroid 1ml+normal saline 4ml) + Physical therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. Primary frozen shoulder
- 2. Older than 18 years of age and less than 75 years of age
- 3. The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS
- 4. The passive activity of the side shoulder joint in at least 2 directions in the three directions of front, internal and outer rotation decreased by more than 30 degrees compared to the side shoulder joint or the normal reference value
- 5. corticosteroid injections were not given within 3 months of visit
Key exclusion criteria (6 listed)
- 1. A history of trauma, osteoarthritis, tumors, etc.
- 2. Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed
- 3. There is a history of corticosteroid injections within 3 months of visit
- 4. Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection
- 5. Both side shoulder joints become ill at the same time
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)Also: corticosteroidGluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml) | Drug | Gluteal muscle injection plus physical therapy group |
| Compound betamethasone Injection(Subacromial Ultrasound Guided injection)Also: corticosteroidGluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml) | Drug | Subacromial Ultrasound Guided injection plus physical therapy group |
| Physical therapypaticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home | Behavioural | Gluteal muscle injection plus physical therapy group, Subacromial Ultrasound Guided injection plus physical therapy group |
Primary outcome
The Change of Shoulder Pain and Disability Index (SPADI)
Time frame: 0,1,2,4,8,12 weeks
The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
5 secondary outcomes
The Change of Numeric Rating Scale for Pain (NRS) (Score: 0-10)
Time frame: 0,1,2,4,8,12 weeks
Anterior flexion of shoulder joint (0-180°)
Time frame: 0,1,2,4,8,12 weeks
shoulder joint abduction (0-180°)
Time frame: 0,1,2,4,8,12 weeks
shoulder internal rotator (1-18 score)
Time frame: 0,1,2,4,8,12 weeks
shoulder external rotator (0-180°)
Time frame: 0,1,2,4,8,12 weeks
Results and safety
The study was stopped early (reason given: Since the COVID-19 pendemic, the regular follow-up of participant became very hard. The participant were not willing to go back to the hospital for repeat measurement. So we stop the study and plan to redesign the protocol.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Individual participant dataSharing planned: Yes. I'd like to share the IPD with the other researchers after the paper is published.
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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.
Pintong Huang principal investigator
Department of Ultrasound in Medicine, The Second Affiliated AHospital of Zhejiang University
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 Compound betamethasone Injection(Gluteal muscle injection), Compound betamethasone Injection(Subacromial Ultrasound Guided injection) and Physical therapy in people with Frozen Shoulder and Shoulder Pain, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site 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 6 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: stopped early, as of the sponsor's last update on 29 Dec 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 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 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?
The study was stopped early (reason given: Since the COVID-19 pendemic, the regular follow-up of participant became very hard. The participant were not willing to go back to the hospital for repeat measurement. So we stop the study and plan to redesign the protocol.). Results are not available in the source record.
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 Change of Shoulder Pain and Disability Index (SPADI) (time frame: 0,1,2,4,8,12 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 29 Dec 2023.