Frozen shoulder
Conditions
Interventions
Intervention Group:Wantong Jinbu Plaster
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: 1. Patients diagnosed with "periarthritis of the shoulder" according to Western medicine criteria, in the painful stage, primarily unilateral cases. 2. Patients diagnosed with "cold-damp obstruction syndrome" according to Traditional Chinese Medicine criteria. 3. Patients aged between 40 and 65 years (inclusive of both 40 and 65), with no gender restrictions. 4. Must be enrolled participants in the "Disease- Integration Cohort for Periarthritis of the Shoulder (Phase I)". 5. Patients who have provided informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with complete rotator cuff tear, cervicobrachial syndrome, bone tumor, or shoulder joint tuberculosis. (2) Patients with other painful shoulder conditions, such as cervical disc herniation, rheumatic arthritis, rheumatoid arthritis, etc. (3) Patients with shoulder pain caused by trauma, fracture, dislocation, infection, neuropathy, or other disorders. (4) Patients who have undergone surgical treatment on the target shoulder joint (including arthroscopic surgery, orthopedic surgery, chondrocyte transplantation, etc.). (5) Patients who have received intra-articular injection therapy in the target shoulder joint within 30 days prior to randomization. (6) Patients who have taken nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days prior to randomization. (7) Patients who have received acupuncture, acupotomy, or acupoint injection within 1 week prior to randomization, or who have received massage therapy, cupping, or infrared therapy within 3 days prior to randomization. (8) Patients with referred shoulder pain due to hepatobiliary, cardiopulmonary, breast, or other diseases, or those with severe diseases involving the heart, brain, liver, kidney, endocrine, or hematopoietic systems. (9) Patients with skin lesions (e.g., ulcers, rash) or scarred skin at the target shoulder site. (10) Patients with bilateral periarthritis of the shoulder. (11) Patients with diabetes mellitus. (12) Patients with bradycardia indicated by electrocardiogram during the screening period. (13) Patients with a history of drug allergies or other allergic diseases (e.g., asthma, urticaria, eczematous dermatitis), or those allergic to the trial medication or rescue analgesics, or with a history of contact dermatitis. (14) Pregnant women, women with suspected or planned pregnancy (within 3 months after trial completion), breastfeeding women, or patients (including both males and females) unwilling to use contraception during the study period. (15) Patients who have participated in or are currently participating in other clinical trials within the past month. (16) Patients with suspected or confirmed history of alcohol or drug abuse, or mental illness. (17) Patients with poor compliance, unable to adhere to medication or attend follow-up visits as required. (18) Patients deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant-Murley; | — |
Secondary
| Measure | Time frame |
|---|---|
| VisualAnalogueScale,VAS;The Short-From-36 Health Survey,SF-36;TCM Symptom Score;Pain Disappearance Rate;Onset Time of Pain Relief;Time to Recovery of Joint Motion;Shoulder MRI; | — |
Countries
China
Contacts
Public ContactLiu Aifeng
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed