Dataset Information

Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial.

ABSTRACT:

Background

Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. However, there is insufficient evidence regarding the effects of DS on ankle sprains. Accordingly, we assessed the efficacy and safety of DS for the treatment of acute lateral ankle sprain (ALAS).

Methods

This study was a multicenter (two Korean hospitals), randomized, double-blind, placebo-controlled, parallel-arm clinical trial with a 1:1 allocation ratio that included a per-protocol analysis and sub-analysis based on symptom severity. Forty-eight participants (n?=?28 at Semyung University Korean Medicine Hospital in Chungju; n?=?20 at DongShin University Gwangju Korean Medicine Hospital) with grade I or II ALAS that occurred within 72?h before enrollment were randomized to a DS (n?=?24) or placebo (n?=?24) group. Both groups received acupuncture treatment once daily for 5 consecutive days and the trial medication (DS/placebo capsule) three times a day for 7 consecutive days. Primary (visual analog scale [VAS] scores for pain) and secondary (Foot and Ankle Outcome Scores [FAOS], edema, and European Quality of Life Five-Dimension-Five-Level Scale [EQ-5D-5L] scores) outcome measures were recorded at baseline (week 0), the end of the intervention (week 1), and 4?weeks after treatment completion (week 5).

Results

Forty-six participants completed the trial (n?=?23 each). Changes in VAS scores, FAOS Symptom/Rigidity, and FAOS Ache from week 1 to week 5 showed significant differences between the two groups. Sub-analyses showed significant differences in changes of FAOS Ache (week 0 to week 5) and VAS scores, total FAOS, and EQ-5D-5L scores (week 1 to week 5) between the two subgroups (grade II). There were no adverse events and significant negative changes in clinical laboratory parameters in both groups.

Conclusions

Overall, the results of this study are in favor of DS combined with acupuncture and suggest that DS combined with acupuncture is a safe treatment with positive long-term effects in terms of pain reduction and symptom alleviation in patients with grade I or II ALAS.

Trial registration

Clinical Research Information Service KCT0002374 . Registered on July 11, 2017; retrospectively registered.

SUBMITTER: Kim JH

PROVIDER: S-EPMC7934479 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial.

Kim Jae-Hong JH Lee Cham-Kyul CK Lee Eun-Yong EY Cho Myoung-Rae MR Lee Young-Su YS Lee Jeong-Soon JS

Trials 20210304 1

<h4>Background</h4>Dangguixu-san (DS), a herbal extract, is widely used in Korean medicine to treat pain and swelling caused by ankle sprain. However, there is insufficient evidence regarding the effects of DS on ankle sprains. Accordingly, we assessed the efficacy and safety of DS for the treatment of acute lateral ankle sprain (ALAS).<h4>Methods</h4>This study was a multicenter (two Korean hospitals), randomized, double-blind, placebo-controlled, parallel-arm clinical trial with a 1:1 allocati ...[more]

PMID: 33663582

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Project description:BackgroundAnkle 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/designIn 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.DiscussionThis study is expected to provide evidence regarding the efficacy, safety, and usefulness of DS for the treatment of ALAS.Trial registrationcris.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).

Project description:BACKGROUND:Ankle sprains are some of the most frequent injuries of the musculoskeletal system. However, there is no substantive evidence supporting which treatment strategy is superior. Taping with Kinesiotape (KT) is a new method that is used as an alternative to the more established taping and bracing techniques used for the prophylaxis and treatment of ankle sprains. The aim of this study is to examine the efficacy of KT on ankle sprain by comparing acupuncture combined with KT (AcuKT) with acupuncture alone in patients with acute lateral ankle sprains. METHODS/DESIGN:This study is a prospective, multi-center (DongShin University Gwangju Oriental Hospital, DongShin University Mokpo Oriental Hospital, and KyungHee Korean Medicine Hospital), outcome assessor-blinded, randomized controlled clinical trial with a 1:1 allocation ratio. Participants (n = 60) with a lateral ankle sprain occurring within 1 week of the study will be randomly assigned to either an acupuncture group (n = 10 at each center (total n = 30)) or an AcuKT group (n = 10 at each center (total n = 30)). The acupuncture group will receive acupuncture treatment at ST36, ST41, BL60, BL62, KI3, KI6, GB39, and GB40 once per day, 5 days per week (excluding Saturday and Sunday) for 1 week. The AcuKT group will receive acupuncture treatment at ST36, ST41, BL60, BL62, KI3, KI6, GB39, and GB40 and the ankle meridian tendino-musculature and a figure-of-eight shape form of KT treatment once per day, 5 days per week (excluding Saturday and Sunday) for 1 week. The primary outcome will be pain evaluation assessed according to a Visual Analogue Scale (VAS), while Foot and Ankle Outcome Score (FAOS), edema, European Quality of Life Five Dimension-Five Level Scale (EQ-5D-5 L) score, and number of recurrent ankle sprains will be considered as secondary outcome measures. VAS, FAOS, and edema measurements will be performed at baseline (before intervention), 5 days after the first intervention (i.e., at the end of the intervention), and 4 weeks after the completion of intervention. EQ-5D-5 L measurements will be conducted at baseline, 5 days after the first intervention, 4 weeks after the completion of intervention, and 26 weeks after the completion of intervention. The number of recurrent ankle sprains will be determined at 4, 8, 12, and 26 weeks after the completion of the intervention. DISCUSSION:This study will provide data regarding the efficacy of KT for the treatment of acute lateral ankle sprain. The results may lead to insights into the usefulness of KT in the treatment of acute lateral ankle sprain. TRIAL REGISTRATION:cris.nih.go.kr, ID: KCT0002257. Registered on 27 February 2017, and approved by the Ministry of Food and Drug Safety (Medical Device Clinical Trial Plan Approval #737).

Project description:BackgroundEvidence for the add-on effect of kinesiotape (KT) with acupuncture for treating ankle sprains remains insufficient. We assessed the add-on effect of KT on ankle sprains by comparing acupuncture combined with KT (AcuKT) with acupuncture alone in patients with acute lateral ankle sprain (ALAS).MethodsThis study was a multicenter, randomized controlled clinical trial that included a per-protocol analysis of the add-on effect of KT on ALAS. The randomization was software based and only the assessors were blinded. Sixty participants (20 each from three centers) with grade I or II ALAS were randomly assigned to acupuncture (n?=?30) or AcuKT (n?=?30) groups. Both groups received acupuncture treatment once daily, 5?days per week for 1?week. The AcuKT group received additional KT treatment. Visual analog scale (VAS) scores for pain and the Foot and Ankle Outcome Score (FAOS) were obtained, and edema measurements were performed at baseline (week 0), at the end of the intervention (week 1), and at 4?weeks after intervention (week 5). The European Quality of Life Five Dimension-Five Level Scale (EQ-5D-5?L) measurements were conducted at week 0, week 1, week 5, and week 26 after the intervention. The number of recurrent ankle sprains was determined at 4, 8, 12 and 26?weeks after the intervention.ResultsFifty-six patients with ALAS completed the trial (AcuKT group, n?=?27; acupuncture group, n?=?29). There were significant changes in visual analog scale score (AcuKT, P <?0.001; acupuncture, P <?0.001), the FAOS (AcuKT, P <?0.001; acupuncture, P <?0.001), and EQ-5D-5?L measurements (AcuKT, P <?0.001; acupuncture, P <?0.001) within both groups. There were no significant differences between groups in terms of any outcome or in a subanalysis based on symptom severity.ConclusionsThese results indicate that AcuKT did not show a positive add-on effect of KT with acupuncture in terms of pain reduction, edema, recovery of function, activities of daily living, quality of life or relapse of ALAS.Trial registrationClinical Research Information Service (cris.nih.go.kr), KCT0002257. Registered on 27 February 2017.

Project description:BackgroundAnkle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV) is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains.Methods/design60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D.DiscussionThis is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various neuromuscular parameters, WBV is a promising treatment method for patients with acute unstable inversion ankle sprains.Trial registrationNCT01702597.

Project description:BackgroundOne-third of individuals who sustain an acute lateral ankle ligament sprain suffer significant disability due to pain, functional instability, mechanical instability or recurrent sprain after recovery plateaus at 1 to 5 years post injury. The identification of early prognostic factors associated with poor recovery may provide an opportunity for early-targeted intervention and improve outcome.MethodsWe performed a comprehensive search of AMED, EMBASE, Psych Info, CINAHL, SportDiscus, PubMed, CENTRAL, PEDro, OpenGrey, abstracts and conference proceedings from inception to September 2016. Prospective studies investigating the association between baseline prognostic factors and recovery over time were included. Two independent assessors performed the study selection, data extraction and quality assessment of the studies. A narrative synthesis is presented due to inability to meta-analyse results due to clinical and statistical heterogeneity.ResultsThe search strategy yielded 3396 titles/abstracts after duplicates were removed. Thirty-six full text articles were then assessed, nine of which met the study inclusion criteria. Six were prospective cohorts, and three were secondary analyses of randomised controlled trials. Results are presented for nine studies that presented baseline prognostic factors for recovery after an acute ankle sprain. Age, female gender, swelling, restricted range of motion, limited weight bearing ability, pain (at the medial joint line and on weight-bearing dorsi-flexion at 4 weeks, and pain at rest at 3 months), higher injury severity rating, palpation/stress score, non-inversion mechanism injury, lower self-reported recovery, re-sprain within 3 months, MRI determined number of sprained ligaments, severity and bone bruise were found to be independent predictors of poor recovery. Age was one prognostic factor that demonstrated a consistent association with outcome in three studies, however cautious interpretation is advised.ConclusionsThe associations between prognostic factors and poor recovery after an acute lateral ankle sprain are largely inconclusive. At present, there is insufficient evidence to recommend any factor as an independent predictor of outcome. There is a need for well-conducted prospective cohort studies with adequate sample size and long-term follow-up to provide robust evidence on prognostic factors of recovery following an acute lateral ankle sprain.Trial registrationProspero registration: CRD42014014471.

Project description:BackgroundThe efficacy of acupuncture for acute ankle sprain (AAS) is controversial. This study aimed to critically assess the efficacy and safety of acupuncture for AAS.MethodsParallel-group randomized controlled trials (RCTs) were included regardless of language or publication date. Participants with AAS were included regardless of age, sex, race, nationality, or diagnostic criteria for AAS. Experimental interventions included acupuncture alone or in combination with traditional therapies. Control interventions included no treatment, placebo, or traditional therapies. The primary outcome was the Kofoed ankle score. The secondary outcomes included visual analogue scale, duration of pain, use of painkiller, ankle circumference, effective rate, cure rate, and adverse events. PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang Digital Periodicals, and Chinese Science and Technology Periodicals database were searched to identify potentially eligible studies from inception to September 10, 2020. World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), ClinicalTrials.gov, Chinese Clinical Trial Registry (ChiCTR), and the reference list of eligible RCTs were checked to identify ongoing or unpublished studies. Risk of bias was assessed by the Cochrane Collaboration's tool. Statistical analyses were performed by RevMan 5.3 software. P < 0.05 indicated statistical significance.ResultsSeventeen eligible studies were included for the statistical analysis. There was no statistically significant difference of Kofoed ankle score between acupuncture and Rest, Ice, Compression, and Elevation (RICE) group (P=0.75). However, acupuncture could significantly relieve pain (P=0.02) and increase cure rate (P=0.004) compared with RICE. Moreover, acupuncture plus RICE could also significantly relieve pain (P < 0.00001) and increase cure rate (P=0.01) compared with RICE alone. Acupuncture combined with massage could significantly relieve pain (P=0.04) compared with massage alone. Acupuncture plus Chinese medicine might be more effective for relieving pain (P < 0.00001), reducing the duration of pain (P < 0.00001), and increasing cure rate (P=0.0002) compared with Chinese medicine alone. Two studies reported no adverse reactions. One study reported that a participant suffered from mild drug-related allergic reaction and was healed without treatment.ConclusionsThe findings of the present study suggest that acupuncture may be beneficial for AAS. However, more large-scale and well-designed RCTs are warranted.

Dataset Information

Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial.

Background

Methods

Results

Conclusions

Trial registration

Publications

Effects of Dangguixu-san in patients with acute lateral ankle sprain: a randomized controlled trial.

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