Traditional Chinese Medicine Clinical Trial
Official title:
Therapeutic Effects of Topical Herbal Medicine on Upper Extremities Fracture
Verified date | October 2020 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | September 21, 2022 |
Est. primary completion date | September 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Keelung Chang Gung Memorial Hospital | Keelung |
Lead Sponsor | Collaborator |
---|---|
YUAN-CHIEH YEH |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | swelling | recording circumference at the swelling site by tape measure | 1 week | |
Primary | 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 | |
Secondary | 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 | |
Secondary | recovery of bone alignment and union at the fracture site | validated with radiographic images | 1 week |
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