Effects of Dangguixu-san on acute lateral ankle sprain: study protocol for a randomized controlled trial

Autor: Cham-Kyul Lee, Eun-Yong Lee, Myung-Rae Cho, Jae-Hong Kim, Ji-Hyun Cho
Jazyk: angličtina
Rok vydání: 2018
Předmět:
medicine.medical_specialty
Time Factors
Visual analogue scale
Ecchymosis
Acupuncture Therapy
Medicine (miscellaneous)
Placebo
law.invention
03 medical and health sciences
0302 clinical medicine
Quality of life
Randomized controlled trial
Double-Blind Method
law
Recurrence
Republic of Korea
Dangguixu-san
Study protocol
medicine
Humans
Pharmacology (medical)
030212 general & internal medicine
Ankle Injuries
Pain Measurement
Randomized Controlled Trials as Topic
lcsh:R5-920
business.industry
Plant Extracts
Double-blind
030229 sport sciences
Recovery of Function
medicine.disease
Combined Modality Therapy
Clinical trial
medicine.anatomical_structure
Treatment Outcome
Musculoskeletal injury
Physical therapy
medicine.symptom
Ankle
business
lcsh:Medicine (General)
Ankle sprain
Ankle Joint
Drugs
Chinese Herbal
Zdroj: Trials, Vol 19, Iss 1, Pp 1-10 (2018)
Trials
ISSN: 1745-6215
Popis: Background Ankle sprain is a common musculoskeletal injury. In Korean medicine, blood stasis is thought to be the main cause of pain and swelling in patients with ankle sprain. Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine for the treatment of traumatic ecchymosis and pain by promoting blood circulation and relieving blood stasis. However, the effects of DS on ankle sprain have not been evaluated in a randomized clinical trial. Here, we describe the protocol for a randomized controlled trial that will evaluate the efficacy and safety of DS for the treatment of ankle sprain. Methods/design In this randomized, double-blinded, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio, participants (n = 48) with acute lateral ankle sprain (ALAS) that occurred within 72 h before enrollment will be randomly assigned to a DS (n = 24) or a placebo (n = 24) group. Both groups will receive acupuncture treatment once a day for 5 days a week (excluding Saturday and Sunday) and the trial medication (DS/placebo capsule) three times a day for seven consecutive days. The primary outcome measure will be pain relief evaluated using a Visual Analog Scale (VAS). Secondary outcome measures will include Foot and Ankle Outcome Scores (FAOS), edema, European Quality of Life Five-Dimension-Five-Level Scale (EQ-5D-5 L) scores, and the number of recurrent ankle sprains. VAS, FAOS, edema, and EQ-5D-5 L scores will be recorded before, at the end of, and at 4 weeks after treatment completion. EQ-5D-5 L scores will be additionally recorded at 26 weeks after treatment completion. The number of recurrent ankle sprains will be recorded at 4, 8, 12, and 26 weeks after treatment completion. Discussion This study is expected to provide evidence regarding the efficacy, safety, and usefulness of DS for the treatment of ALAS. Trial registration cris.nih.go.kr, registration number: KCT 0002374. Registered on 11 July, 2017 and approved by the Ministry of Food and Drug Safety (registration number, 31244). Electronic supplementary material The online version of this article (10.1186/s13063-018-2571-1) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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