Clinical trial NCT04593849: Therapeutic Effects of Traditional Chinese Medicine in Topical Use on Upper Extremities Fracture
Official title: Therapeutic Effects of Topical Herbal Medicine on Upper Extremities Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bone Fractures
Traditional Chinese Medicine
Chinese Herbal Medicine
Keywords: Wan Yin Gao
Chinese herbal patch
Upper Extremity fracture
Ru Yih Jin Huang Saan
Chinese herbal ointment
Wan Yin Gao Jia Jean Wey
Upper Extremities Fracture
Traditional Chinese Medicine
Chinese herbal medicine
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-10-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Aged above 18 years with upper extremity fractures, including clavicle fractures, humerus fractures, forearm fractures, carpal bone fractures, finger fractures, etc.
* simple fractures with non-displacement or mild displacement, including transverse fracture, oblique fracture, linear fracture, impacted fracture, etc
* no need for surgery according to the orthopedist's evaluation
* willing to sign the informed consent of study and can cooperate with the doctor
* According to the orthopedist's evaluation, the soft tissue injury was grade C0 or C1 by Tscherne classification and without a high risk of infection

Exclusion Criteria:

* Compound fractures
* Simple fractures with moderate displacement or severe displacement
* The fracture pattern was a simple fracture but unstable, such as communicated fracture, etc.
* need for surgery according to the orthopedist's evaluation
* there were open wounds or at a high risk of infection
* According to the orthopedist's evaluation, the soft tissue was grade C2 or above by Tscherne classification and at a high risk of infection
* Unable to complete the questionnaire or cooperate with the doctor
* Allergy to Chinese herbal medicine patch or ointment
* Pregnancy
* heavy smoker
* Systemic diseases such as severe anemia, thyroid disease, uncontrolled diabetes mellitus, etc.
* Patients already on other treatment for upper extremity fractures, such as acupuncture therapy or transcutaneous electrical nerve stimulation
* Using other Chinese herbal medicine patch or ointment for treating upper extremity fractures

Primary outcomes:
measure: reduction of pain
timeFrame: 1 week
measure: swelling
timeFrame: 1 week
measure: absence of adverse skin reaction to topical medicine
timeFrame: 1 week
Secondary outcomes:
measure: improvement of functional performances
timeFrame: 1 week
measure: recovery of bone alignment and union at the fracture site
timeFrame: 1 week
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Keelung Chang Gung Memorial Hospital
Study officials:
References: