Frozen shoulder
Conditions
Interventions
Experimental group:Swelling and pain aerosol
Control group:Swelling and Pain Aerosol Placebo
Sponsors
The First People's Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 75 years, any gender; (2) Meets the diagnosis of 'Periarthritis of the Shoulder' according to the 'Guidelines for Traditional Chinese Medicine Diagnosis and Treatment of Periarthritis of the Shoulder' (2022); (3) Disease course = 4, with one shoulder selected as the target study site (if there is a difference in pain severity between the two shoulders, the more severely affected shoulder is chosen; if both shoulders have equal pain severity, the right shoulder is chosen); (5) Participants voluntarily join this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) There are open wounds, skin lesions (such as exudative dermatitis) or active infection (herpes, shingles, impetigo) in the medication area; (2) Those who are judged by the investigator to have active or likely exacerbate skin diseases with topical treatment, such as systemic lupus erythematosus skin lesions, acute attack of psoriasis, active eczema; (3) Combined with serious primary diseases of the heart, cerebrovascular, lung, liver, kidney, hematopoietic, immunological, neuropsychiatric system, malignant tumors, and severe malnutrition; (4) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 times the upper limit of reference value (ULN), serum creatinine (Cr) > 1.5 times ULN; (5) Have a clear history of shoulder trauma or sprain within 1 month; (6) Accompanied by shoulder fracture, dislocation, osteoarthritis or shoulder tumor, rotator cuff injury Ellman classification is rotator cuff partial tear grade 2 or above (tear depth>=3mm) or rotator cuff full-thickness tear, subacromial impingement syndrome, or cervical spondylosis; (7) Target shoulder joint pain caused by non-frozen shoulder diseases such as rheumatoid arthritis and ankylosing spondylitis; (8) Within 1 week before enrollment or during the planned study period, other treatment methods for the treatment of frozen shoulder or potentially affecting the efficacy of frozen shoulder, including Western medicines (such as NSAIDs, central analgesics, skeletal muscle relaxants), traditional Chinese medicines and non-drug treatments (such as manual therapy, acupuncture therapy, physical therapy, injection therapy, and surgical treatment) during the planned study period; (9) Those who are allergic to alcohol or allergic to the known ingredients of the test drug and emergency drug in this study; (10) Pregnant, lactating women, or those who have a birth plan during the study and within 6 months of the last drug (including female partners of male participants); (11) Those who have poor compliance or difficulty in completing the trial process as assessed by the investigator: if they have a history of alcohol/drug abuse or drug abuse, or live far away and are difficult to cooperate with follow-up, or are difficult to cooperate with the relevant examinations and tests due to mental illness, visual impairment, or hearing impairment; (12) Participation in clinical trials of other drugs or medical devices within 3 months prior to randomization; (13) Participants who are assessed by the investigator to be unsuitable for participating in this trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the Numeric Rating Scale (NRS) score for shoulder joint pain after 14 days of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in shoulder joint pain NRS score from baseline after 3 and 7 days of medication;Area under the curve of shoulder joint pain NRS scores;Efficacy of pain treatment after 3, 7, and 14 days of medication;Onset time of pain treatment;Change from baseline in Constant-Murley Shoulder Score (CMS) at 7 and 14 days of medication;Changes from baseline in each item of the CMS shoulder joint range of motion score (elevation, abduction, external rotation, internal rotation) at 7 and 14 days of medication use;Changes in pain biomarkers from baseline after 14 days of medication;Changes in the 7- and 14-day medication health survey scale (EQ-5D) from baseline;Emergency medication usage (number of medication cases, number of patients, average medication dosage, average days of medication); | — |
Countries
China
Contacts
Public ContactHou Jianhong; Li Yanhua; Xie Xuhua; Pan Xukun
The First People's Hospital of Yunnan Province
Outcome results
None listed