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There is no study evaluating the clinical effect of traditional chinese medicine(TCM) in topical use on musculotendinous injury, nor is that investigating the effectiveness on bone fracture healing. We hypothesize that with aid of topical chinese herbal medicine in addition to oral analgesics can be more beneficial in treating post traumatic injury, launching early mobilization, and enhancing fracture healing process.
Orthopedic fractures are a common acute health issue, which often accompanied with life-long burden, accounts up to 34% total lifetime medical costs in the United States. It may also lead to significant long-term morbidity and, potentially, mortality if treated Improperly. Initial management is particularly crucial in helping the bone fracture healing process and reducing comorbidity. Apart from fracture fixation through nonoperative/conservative or operative methods in aim to restore anatomic alignment, oral analgesics are same important in Orthopedics patients in symptomatic control and for early mobilization. Non-opioid medication such as Acetaminophen or NSAIDs are routinely used for injury or postoperative pain management, despite that inevitable side effects including gastrointestinal bleeding and inconsistent show concerns of NSAIDs impairing bone healing in historical animal-based studies.
In which case, topical agents used in traditional chinese medicine(TCM) usually become a well-placed supplement to relieve inflammatory conditions. In spite of the lack of scientific evidence of efficacy, topical applications such as Ru- Yih-Jin-Huang-Saan (RYJHS) and Wan-Yin-Gao(WYG) have been used on musculoskeletal injuries in oriented countries for centuries, as their transcutaneous transport of the herbal chemicals to deeper tissues show biological activities of anti-inflammation, reducing swelling soft tissue, angiogenesis, fracture healing and cellular proliferation.
To date, there is no study evaluating the clinical effect of traditional chinese medicine in topical use on musculotendinous injury, nor is that investigating the effectiveness on bone fracture healing. We hypothesize that with aid of topical chinese herbal medicine in addition to oral analgesics can be more beneficial in treating post traumatic injury, launching early mobilization, and enhancing fracture healing process.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A (Ru-Yih-Jin- Huang-Saan group) | Active Comparator | Herbal medicine(Ru-Yih-Jin- Huang-Saan) will be applied to injured site and covered with gauze for 6 hours per day. Each subject will receive persistent treatment for 1 week |
|
| group B (Wan-Yin-Gao-Jia-Jean-Wey group) | Experimental | Herbal medicine (Wan-Yin-Gao-Jia-Jean-Wey) will be applied to injured site and covered with gauze for 6 hours per day. Each subject will receive persistent treatment for 1 week |
|
| placebo group( topical agent without therapeutic effects) | Placebo Comparator | topical agent without therapeutic effects will be applied to injured site and covered with gauze for 6 hours per day. Each subject will receive persistent treatment for 1 week |
|
| control group | No Intervention | only oral analgesics will be applied to patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ru-Yih-Jin- Huang-Saan(RYJHS), Wan-Yin-Gao-Jia-Jean-Wey(WYGJJW), placebo ( topical agent without therapeutic effects) | Other | We conduct a clinical trial using topical herbal medicine, including Ru-Yih-Jin- Huang-Saan(RYJHS) and Wan-Yin-Gao-Jia-Jean-Wey (WYGJJW) in treating post fracture pain and tissue swell. 24 eligible participants diagnosed of upper limb fracture with soft tissue injury grading of C1, C0 from Tscherne classification transferred from Orthopedic outpatient clinic and inpatient will be enrolled and randomly allocated to 4 groups, including experimental group A (RYJHS group), group B (WYGJJW group), placebo group( topical agent without therapeutic effects), and control group (only oral analgesics group), with 6 participants in each group. |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of pain | quantified by Visual Analogue Scale scoring system, Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain", providing a range of scores from 0-100 [100-mm scale]. A higher score indicates greater pain intensity. | 1 week |
| swelling | recording circumference at the swelling site by tape measure | 1 week |
| absence of adverse skin reaction to topical medicine | scored with Dyshidrotic Eczema Area and Severity Index (DASI index). The total score of the DASI results from the sum of severity grade score points of each of the four items (V = vesicles, E = erythema, S = desquamation, I = itch) multiplied by the affected area (A) score points: DASI = (pV + pE + pS + pI) × pA. The maximum possible score is 60. By the DASI, the dyshidrotic eczema is graded as: mild (0-15), moderate (16-30) and severe (31-60). | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| improvement of functional performances | calculated by The Disabilities of the Arm, Shoulder and Hand Score (QuickDash), ranging from 0 (no disability) to 100 (most severe disability) | 1 week |
| recovery of bone alignment and union at the fracture site |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keelung Chang Gung Memorial Hospital | Keelung | 20401 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40520457 | Derived | Lin WY, Lu CA, Chang CW, Yeh YC. Therapeutic Effects of Topical Traditional Chinese Medicine on Upper Extremity Fractures. Int J Gen Med. 2025 Jun 9;18:2973-2988. doi: 10.2147/IJGM.S511294. eCollection 2025. |
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validated with radiographic images
| 1 week |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| ID | Term |
|---|---|
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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