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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
gluteal injection of 1 ml of Compound betamethasone and 4 ml of 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.
ultrasound-guided subacromial injection of 5 ml of normal saline at week 0,2,4.
gluteal injection of 5 ml 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.
Guangde County People's Hospital
Xuancheng, Anhui, China
Yangpu District Central Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The First People's Hospital of Linping District, Hangzhou
Hangzhou, Zhejiang, China
Huzhou Central Hospital
Huzhou, Zhejiang, China
Pujiang People's Hospital
Jinhua, Zhejiang, China
First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Xiangshan County Traditional Chinese Medicine Hospital Healthcare Group
Ningbo, Zhejiang, China
Shengzhou People's Hospital
Shanhu, Zhejiang, China
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).
Time frame: Baseline and 12 weeks
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.
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）
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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week8 and week12
work absenteeism
The questionnaire surveys the number of workdays missed since the onset of frozen shoulder is collected at baseline.
Time frame: Week 0
work absenteeism
The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 0 and week 4
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