Most ankle sprain research is either false or clinically unimportant: A 30-year audit of randomized controlled trials.
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ABSTRACT: Background
Lateral ankle sprain is the most common musculoskeletal injury. Although clinical research in this field is growing, there is a broader concern that clinical trial outcomes are often false and fail to translate into patient benefits.Methods
We audited 30 years of experimental research related to lateral ankle sprain management (n = 74 randomized controlled trials) to determine if reports of treatment effectiveness could be validated beyond statistical certainty.Results
A total of 77% of trials reported positive treatment effects, but there was a high risk of false discovery. Most trials were unregistered and relied solely on statistical significance, or lack of statistical significance, rather than on interpreting key measures of minimum clinical importance (e.g., minimal detectable change, minimal clinically important difference).Conclusion
Future clinical trials must adopt higher standards of reporting and data interpretation. This includes consideration of the ethical responsibility to preregister their research and interpretation of clinical outcomes beyond statistical significance.
SUBMITTER: Bleakley CM
PROVIDER: S-EPMC8500808 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:A select 10-30% of patients with recurrent lateral ankle sprains develop chronic ankle instability (CAI). Patients with chronic ankle instability describe a history of the ankle "giving way" with or without pathological laxity on examination. Evaluation includes history, identification of predisposing risk factors for recurrent sprains, and the combination of clinical tests (eg, laxity tests) with imaging to establish the diagnosis. There are a variety of nonoperative strategies to address chronic ankle instability, which include rehabilitation and taping or bracing to prevent future sprains. Patients who fail conservative treatment are candidates for surgery. The anatomic approaches (eg, modified Broström) are preferred to nonanatomic procedures since they recreate the ankle's biomechanics and natural course of the attenuated ligaments. There is a growing interest in minimally invasive procedures via ankle arthroscopy that also address the associated intra-articular disorders. This article provides a review of chronic lateral ankle instability consisting of relevant anatomy, associated disorders, evaluation, treatment methods, and complications.Level of evidenceLevel V, expert opinion.
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Project description:BackgroundDuring the recovery period after acute ankle sprain, it is unclear whether conventional treatment should be supported by supervised exercise.AimTo evaluate the short- and long-term effectiveness of conventional treatment combined with supervised exercises compared with conventional treatment alone in patients with an acute ankle sprain.DesignRandomised controlled clinical trial.SettingA total of 32 Dutch general practices and the hospital emergency department.MethodAdults with an acute lateral ankle sprain consulting general practices or the hospital emergency department were allocated to either conventional treatment combined with supervised exercises or conventional treatment alone. Primary outcomes were subjective recovery (0-10 point scale) and the occurrence of a resprain. Measurements were carried out at intake, 4 weeks, 8 weeks, 3 months, and 1 year after injury. Data were analysed using intention-to-treat analyses.ResultsA total of 102 patients were enrolled and randomised to either conventional treatment alone or conventional treatment combined with supervised exercise. There was no significant difference between treatment groups concerning subjective recovery or occurrence of resprains after 3 months and 1-year of follow-up.ConclusionConventional treatment combined with supervised exercises compared to conventional treatment alone during the first year after an acute lateral ankle sprain does not lead to differences in the occurrence of resprains or in subjective recovery.
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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.
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Project description:Ankle sprains are one of the most prevalent athletic injuries. Prior work has investigated lateral ankle sprains, but research on generally more severe medial sprains is lacking. This case report performs a kinematic analysis using novel motion analysis methods on a non-contact medial ankle sprain. Peak eversion (50°) occurred 0.2 seconds following ground contact, maximum velocity of 426°/s, while peak dorsiflexion (64°) occurred with a greater maximum velocity (573°/s). The combination of dorsiflexion at ground contact and rapid eversion is associated with a non-contact eversion sprain. This study provides a quantitative analysis of the eversion ankle sprain injury mechanism.
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Project description:BackgroundDangguixu-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).MethodsThis 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).ResultsForty-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.ConclusionsOverall, 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 registrationClinical Research Information Service KCT0002374 . Registered on July 11, 2017; retrospectively registered.
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Project description:AimFollowing soft tissue ankle injury, patients are often referred for out-patient physiotherapy and present symptoms including pain, reduced range of movement and function, and oedema. In this study, we assess the use of a neuromuscular electrical stimulation (NMES) device as an adjunctive therapy to reduce oedema in patients recovering from grade I and II ankle sprains.MethodsThis was a single-centre, pilot randomised controlled study, recruiting patients referred to physiotherapy following an ankle sprain. Participants presenting with oedema were randomised to one of two treatment groups: (1) the current standard of care and (2) the current standard of care plus NMES use. Participants were identified in an emergency department and referred to a physiotherapy department for treatment 1 to 5 days following the injury and returned to clinic 7 days later.ResultsTwenty-two participants completed the study and had full data sets for analysis (11 in each group). Mean volumetric displacement was reduced in the intervention group in comparison to the standard care group (P = .011); however, there were no between-group differences in figure of eight measurements, function or pain scores. The device was well tolerated, with no device-related adverse events recorded.ConclusionsIn this pilot, randomised controlled trial, NMES was well tolerated by patients following ankle sprain and demonstrated statistically significant improvements in oedema reduction as measured by fluid displacement. No other changes were observed. Further work will need to confirm the clinical significance and effect on longer term recovery post-ankle sprain.
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Project description:BACKGROUND: Ankle sprain is one of the most frequently encountered musculoskeletal injuries; however, the efficacy of acupuncture in treating ankle sprains remains uncertain. We therefore performed a systematic review to evaluate the evidence regarding acupuncture for ankle sprains. METHODS: We searched 15 data sources and two trial registries up to February 2012. Randomized controlled trials of acupuncture were included if they involved patients with ankle sprains and reported outcomes of symptom improvement, including pain. A Cochrane risk of bias assessment tool was used. Risk ratio (RR) or mean difference (MD) was calculated with 95% confidence intervals (CIs) in a random effects model. Subgroup analyses were performed based on acupuncture type, grade of sprain, and control type. Sensitivity analyses were also performed with respect to risk of bias, sample size, and outcomes reported. RESULTS: Seventeen trials involving 1820 participants were included. Trial quality was generally poor, with just three reporting adequate methods of randomization and only one a method of allocation concealment. Significantly more participants in acupuncture groups reported global symptom improvement compared with no acupuncture groups (RR of symptoms persisting with acupuncture?=?0.56, 95% CI 0.42-0.77). However, this is probably an overestimate due to the heterogeneity (I2?=?51%) and high risk of bias of the included studies. Acupuncture as an add-on treatment also improved global symptoms compared with other treatments only, without significant variability (RR 0.61, 95% CI 0.51-0.73, I2?=?1%). The benefit of acupuncture remained significant when the analysis was limited to two studies with a low risk of bias. Acupuncture was more effective than various controls in relieving pain, facilitating return to normal activity, and promoting quality of life, but these analyses were based on only a small number of studies. Acupuncture did not appear to be associated with adverse events. CONCLUSIONS: Given methodological shortcomings and the small number of high-quality primary studies, the available evidence is insufficient to recommend acupuncture as an evidence-based treatment option. This calls for further rigorous investigations.
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Project description:Introduction and importance Sprained ankles in children and adolescents are rare. Certain diagnostic pitfalls must arise in the mind of the clinician because many differential diagnoses must be confirmed or refuted urgently. Among them, the infectious osteoarticular pathology including acute hematogenous osteomyelitis of the tibia or distal fibula and septic arthritis of the subtalar joint. The main purpose of this work, through four clinical cases, we will discuss diagnostic pitfalls in the course of ankle trauma in children and adolescents. Case presentation clinical In this work, we have demonstrated through four cases some diagnostic errors in the context of ankle trauma in children and adolescents. Infectious and malignant tumor pathologies are real diagnostic and therapeutic emergencies. For all these cases, the initial diagnosis was a sprained ankle following a gambling or sports accident. Discussion Ankle trauma in children and adolescents is a frequent reason for consultation in emergencies. The fear of the orthopedic surgeon is to miss a serious pathology and wrongly make the simple diagnosis of a sprained ankle. Temperature measurement must be systematic. The clinical examination must be meticulous. The interpretation of the radiograph must be cautious. Acute hematogenous osteomyelitis and malignant tumor pathology should be on the surgeon's mind. Conclusion We have shown through these four examples that a serious pathology can simulate a sprain. Hence, a careful analysis of clinical, biological and radiological elements is the only guarantee of adequate care. Highlights • Ankle trauma in children is a frequent reason for consultation in trauma emergencies.• Real lesions of the lateral ankle ligament in children are rare.• The measurement of the temperature in a child who consults in traumatology should be systematic.• Interpretation of radiographs should be careful.
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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).
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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.
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