Frozen shoulder
Conditions
Interventions
Experimental Group:Jian Bi Fang + 3D Dynamic Stretching and Rotation Technique + Suspension Squat Shoulder Expansion Rehabilitation Device
Control Group:Celecoxib Capsules + routine joint manipulation + self-functional exercises
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 who meet the diagnostic criteria for "periarthritis of the shoulder" in Western medicine and are in the frozen stage, with unilateral involvement as the primary focus. (2) Patients who meet the diagnostic criteria for "cold-damp obstruction syndrome" in Traditional Chinese Medicine. (3) Patients aged between 40 and 65 years old (inclusive), with no restriction on gender. (4) Patients who are already enrolled participants in the "Disease Cohort of Syndrome Differentiation and Integration for Periarthritis of the Shoulder (Phase I)". (5) Patients who have given informed consent and signed the informed consent form.
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. 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 took nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days prior to randomization. 7. Patients who received acupuncture, scalpel therapy, acupoint injection, or massage, cupping, and infrared therapy within 1 week or 3 days prior to randomization, respectively. 8. Patients with referred shoulder pain caused by hepatobiliary, cardiopulmonary, or breast diseases, or those with severe systemic diseases (e.g., heart, brain, liver, kidney, endocrine, or hematologic disorders). 9. Patients with skin lesions, rashes, or scars at the target shoulder joint. 10. Patients with bilateral shoulder periarthritis. 11. Patients with diabetes mellitus. 12. Patients with bradycardia detected on screening electrocardiogram. 13. Patients with a history of drug allergy, other hypersensitivity disorders (e.g., asthma, urticaria, eczematous dermatitis), or contact dermatitis, or those allergic to the investigational drug or temporary analgesics. 14. Pregnant, potentially pregnant, or planning to become pregnant (within 3 months after the trial), breastfeeding women, or patients refusing contraception during the study (both male and female). 15. Patients who participated in or are currently participating in other clinical trials within the past month. 16. Patients with suspected or confirmed history of alcohol or substance abuse, or mental disorders. 17. Patients with poor compliance, unable to adhere to medication or follow-up visits. 18. Patients deemed unsuitable for clinical trial participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant-Murley Rating Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale;TCM Syndrome Score;Quality of Life Assessment Scale (SF-36);Shoulder MRI;Efficacy Assessment; | — |
Countries
China
Contacts
Public ContactLiu Aifeng
First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed