None listed
Conditions
Interventions
None listed
Sponsors
Kyung Hee University Oriental Medicine Hospital at Gangdong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 20 to 65 years Individuals diagnosed with musculoskeletal disorders (ICD-10 M codes, S codes) without congenital diseases Individuals with no pathological symptoms or abnormal findings at the time of interview, as judged by the investigator Individuals who have received sufficient explanation regarding the purpose and contents of the study, have voluntarily decided to participate, and have signed the IRB-approved written informed consent form
Exclusion criteria
Exclusion criteria: 1. Individuals taking immunosuppressants, antihistamines, or steroids 2. Individuals with autoimmune diseases or diabetic complications 3. Individuals currently participating in other clinical trials, or those deemed unsuitable for this clinical study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whole-transcriptome (RNA-seq) data from blood samples collected before and after bee venom pharmacopuncture. Differentially expressed genes (DEGs) will be identified between the excellent responder group (Group 1) and the severe adverse reaction group (Group 4), and genetic markers associated with BV-related adverse reactions will be derived through feature extraction and In-silico cellular metabolism simulation (Ver1.0). | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity assessment using the 100mm Visual Analogue Scale (VAS). Participants will mark their pain level on a scale from 0mm (no pain) to 100mm (worst imaginable pain), and changes in pain before and after each BV pharmacopuncture session will be measured. The degree of VAS reduction is used as a criterion for group allocation.;Adverse reactions following BV pharmacopuncture (itching, redness/swelling) will be assessed using the following criteria: Itching: + (localized to injection site), ++ (extending beyond injection site), +++ (generalized itching); Redness: + (localized swelling), ++ (extending beyond injection site), +++ (generalized swelling). The more severe of the two will be applied to group allocation.;Complete blood count (CBC) and related clinical laboratory test results, used to evaluate the basic hematological safety profile of BV pharmacopuncture.;Assessment of skin hypersensitivity reactions to bee venom. Local and systemic skin reactions, including redness, swelling, and itching at and around the injection site, will be observed and recorded.;Functional assessment of the affected musculoskeletal region. Patient-reported activities of daily living and changes in functional mobility of the affected area will be compared before and after BV pharmacopuncture. | — |
Countries
Korea, Republic of
Contacts
Public ContactYeon-Cheol Park
Kyung Hee University Oriental Medicine Hospital at Gangdong
Outcome results
None listed