Frozen shoulder
Conditions
Interventions
high-risk group:Not applicable
Frozen Shoulder Pain Stage Group:Not applicable
Frozen shoulder freezing phase group:Not applicable
Frozen shoulder relief phase group:Not applicable
Sponsors
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy population: No complaints of shoulder pain or limited range of motion, normal active and passive range of motion of the shoulder joint, no history of shoulder trauma or surgery, and no history of shoulder joint diseases. High-risk population: Individuals with a history of long-term repetitive shoulder activities, poor sitting posture, overexertion or improper training, insufficient exercise, prolonged shoulder exposure to cold, previous shoulder trauma or surgery, history of periarthritis of the shoulder on the opposite side, rotator cuff injury, tendonitis, hypertension, diabetes, thyroid disease, cervical spondylosis, thoracic spine disease, autoimmune diseases, or cardiovascular and cerebrovascular diseases. Painful stage: Characterized by gradually worsening pain around the shoulder joint, muscle spasms, increased pain at night, restricted active shoulder movement due to pain, and widespread tenderness, including the coracoid process, coracobrachialis ligament, subacromial area, supraspinatus, infraspinatus, long head of the biceps tendon, and quadrangular space. X-ray examination generally shows no significant abnormalities. Frozen stage: Shoulder pain decreases, but tenderness remains widespread, with progressive restriction of shoulder joint movement as the main feature, including reduced active and passive external rotation, internal rotation, and abduction of the shoulder joint, and the surrounding soft tissues of the shoulder joint are in a "frozen" state. Relief stage: Pain gradually disappears, and shoulder joint mobility gradually improves. (1) Patients whose clinical diagnosis meets the criteria of Western medicine and traditional Chinese medicine (TCM) differential diagnosis (meeting any one of the main syndrome types: cold-dampness obstruction, qi stagnation and blood stasis, or deficiency of qi and blood); (2) Patients who meet the definition of any of the above populations; (3) Patients aged 40-65 years, regardless of gender; (4) Patients willing and able to participate in the survey and sign the informed consent form; (5) Patients with unilateral lesions.
Exclusion criteria
Exclusion criteria: (1) Patients with completely ruptured rotator cuff injuries, cervicobrachial syndrome, bone tumors, or tuberculous arthritis of the shoulder joint. (2) Other painful shoulder conditions, such as cervical disc herniation, rheumatic arthritis, and rheumatoid arthritis. (3) Periarticular shoulder pain caused by trauma, fractures, dislocations, infections, or neuropathies, among other conditions. (4) Patients who have undergone previous surgical treatment on the target shoulder joint (including arthroscopic surgery, orthopedic surgery, and cartilage cell transplantation). (5) Patients who received intra-articular injections in the target shoulder joint within 30 days prior to randomization. (6) Patients who have taken nonsteroidal anti-inflammatory drugs (NSAIDs) within the past 3 days prior to randomization. (7) Patients with referred shoulder pain caused by hepatobiliary, cardiopulmonary, or breast diseases, or those with severe comorbidities such as heart, brain, liver, kidney, endocrine, or hematologic disorders. (8) Pregnant women, those with suspected pregnancy, those planning to become pregnant within 3 months after the trial, breastfeeding women, or patients (male or female) who refuse to use contraceptive measures during the study period. (9) Patients who have participated in or are currently participating in other clinical trials within the past month. (10) Patients with a history of suspected or confirmed alcohol or substance abuse, or those with mental illness. (11) Patients deemed unsuitable for participation in the clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive Effectiveness of a Multimodal Dynamic Intelligent Diagnostic and Early Warning System for Periarthritis of the Shoulder; | — |
Secondary
| Measure | Time frame |
|---|---|
| Shoulder Pain and Functional Disability Index Score;Constant-Murley Shoulder Joint Functional Assessment Score;Visual Analog Scale (VAS);Shoulder joint range of motion;Quantitative Measurement Characteristics of Shoulder Joint MRI;Traditional Chinese Medicine (TCM) syndrome quantitative scoring;TCM Four Diagnostic Methods Data;Blood Metabolism and Inflammation Biomarkers; | — |
Countries
China
Contacts
Public ContactLiu Aifeng
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed