Chronic soft tissue injury
Conditions
Interventions
Yunnan Baiyao Ointment Combined with Conventional Treatment Group:Apply Yunnan Baiyao ointment to the painful area in conjunction with standard treatment
Conventional treatment group:Standard diagnostic and treatment methods
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 years or older; gender is not restricted. (2) The investigator determines that the subject has chronic soft tissue injury requiring treatment. Diagnosis may refer to the criteria in the *Guidelines for Clinical Research on Traditional Chinese Medicine (2002 Edition) – Trial Version*: (1) History of chronic injury and typical age of onset; (2) Pain, swelling, and tenderness at the site of strain; (3) Limited mobility at the joint or adjacent to the joint. (3) Pain score (NRS) = 4. (4) Diagnosed by the investigator as having localized pain lasting more than 3 months, including the face, back, buttocks, neck, abdomen, chest, groin, or extremities. (5) Individuals who voluntarily agree to participate in this study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with concomitant fractures or joint dislocations; patients with complete ruptures of soft tissues such as muscles, tendons, or ligaments; patients with concomitant rheumatic diseases, infections, or open wounds. (2) Patients with a history of neurological or psychiatric disorders, such as schizophrenia, depression, epilepsy, or acute epileptic seizures, or those who have been taking psychiatric medications long-term; Those with a known history of alcohol dependence or substance abuse. (3) Patients with concurrent malignant tumors, severe primary cardiovascular disease (cardiovascular disease with significant clinical symptoms and potential for serious complications), severe liver or kidney disease, or severe conditions affecting their survival. (4) Patients with life-threatening soft tissue injuries (e.g., injuries resulting in disability) where the investigator assesses that the efficacy and safety of the study cannot be accurately evaluated. (5) Patients with skin lesions or abnormalities at the application site (e.g., rash, eczema, post-surgical conditions), those with allergic skin conditions; those with a history of allergy to the patch matrix or the investigational drug, or those with a history of multiple allergies (allergic to two or more substances). (6) Individuals with allergies to the study drug or its components (e.g., processed Aconitum carmichaeli, processed Artemisia argyi). (7) Individuals who require frequent exposure to excessively hot environments (e.g., hot baths, saunas) or who perform vigorous scrubbing of the intended application site, which may affect the patch's adhesion or drug absorption. (8) Individuals whose work, exercise, or lifestyle habits make it impossible to ensure stable adhesion of the patch at the intended site. (9) Pregnant or lactating women (as confirmed by the investigator through a medical interview), as well as women of childbearing potential who plan to become pregnant within the next 2 months. (10) Individuals who have participated in other interventional clinical trials within the past 3 months. (11) Individuals with conditions deemed unsuitable for study participation by the investigator, such as physical activity or work conditions that may exacerbate an injury.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain score (Numerical Rating Scale [NRS]) 28 days after the start of treatment compared to baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain relief rates at 14, 21, and 28 days after the start of treatment;Change in pain score (NRS) from baseline at 7, 14, and 21 days after the start of treatment;Change in pain score (NRS) from baseline, assessed daily within 7 days of treatment initiation. Rate of pain improvement, assessed daily within 7 days of treatment initiation. Time to and proportion of patients achieving a 50% reduction in pain score (NRS) compared to baseline within 7 days of treatment initiation. Time to onset of pain improvement.;Change in the Hospital Anxiety and Depression Scale (HADS) score from baseline at 7, 14, 21, and 28 days after the start of treatment;To compare the differences in efficacy between conventional treatment alone and conventional treatment combined with Yunnan Baiyao ointment. Among participants using Yunnan Baiyao ointment, to compare the differences in efficacy between Yunnan Baiyao ointment combined with different conventional treatment regimens and to identify the optimal combination therapy.;In accordance with the *Guidelines for Clinical Research on New Traditional Chinese Medicines (Interim)*, symptoms of soft tissue injury-such as local pain, tenderness, swelling, and functional impairment-should be observed using a quantitative scoring method (see Appendix 1). Scoring should be conducted 7 and 28 days after the start of treatment, and the therapeutic efficacy and response rate should be evaluated.; | — |
Countries
China
Contacts
Public ContactFan Bifa
China-Japan Friendship Hospital
Outcome results
None listed