Comparison of Ultrasound-Guided Subacromial vs. Systemic Steroid Injections for Frozen Shoulder: a Multicenter Pilot Study

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).

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.

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).

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).

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).

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.

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.

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.

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.

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.

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.

The questionnaire surveys the number of workdays missed since the onset of frozen shoulder is collected at baseline.

The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.

The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.

The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.

The questionnaire surveys the number of workdays missed by the subject since the last outpatient research follow-up.

This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up.

This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up.

This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up.

This questionnaire surveys the usage of unplanned concomitant analgesic medications by the subject since the last outpatient research follow-up.

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.

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.

The incidence of serious adverse events (SAE) at 12 weeks

The incidence of adverse events (AE) at 12 weeks