The trAPP-study: cost-effectiveness of an unsupervised e-health supported neuromuscular training program for the treatment of acute ankle sprains in general practice: design of a randomized controlled trial

Abstract

BackgroundAnkle sprains are one of the most frequent injuries of the musculoskeletal system, with yearly around 680.000 new sprains in the Netherlands. Of these, about 130.000 people will visit the general practitioner (GP) each year. In addition, patients have an increased risk of a recurrent ankle sprain and about a third report at least one re-sprain. No optimal treatment strategy has proven to be effective in general practice, however promising results were achieved in a preventive trial among athletes. Therefore, the objective is to examine the (cost)-effectiveness of an unsupervised e-health supported neuromuscular training program in combination with usual care in general practice compared to usual care alone in patients with acute ankle sprains in general practice.Method/DesignThis study is a multi-center, open-label randomized controlled trial, with a one-year follow-up. Patients with an acute lateral ankle sprain, aged between 14 and 65 years and visiting the GP within three weeks of injury are eligible for inclusion. Patients will be randomized in two study groups. The intervention group will receive, in addition to usual care, a standardized eight-week neuromuscular training program guided by an App. The control group will receive usual care in general practice alone. The primary outcome of this study is the total number of ankle sprain recurrences reported during one year follow-up. Secondary outcomes are subjective recovery after one year follow-up, pain at rest and during activity, function, return to sport, cost-effectiveness and compliance of the intervention. Measurements will take place monthly for the study period of 12 months after baseline measurement.DiscussionFor general practitioners the treatment of acute ankle sprains is a challenge. A neuromuscular training program that has proven to be effective for athletes might be a direct treatment tool for acute ankle sprains in general practice. Positive results of this randomized controlled trial can lead to changes in practice guidelines for general practitioners. In addition, since this training program is e-health supported, positive results can also lead to a novel way of injury prevention.Trial registrationDutch Trial Registration: NTR4765.

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

“…Second, because preliminary data for determining the sample size is inadequate, we designed this trial as a single-center pilot study. Third, in previous studies [ 41 – 44 ], recurrences were followed up for 52 weeks; however, because of the short study duration, we have scheduled a follow-up period of only 26 weeks.…”

Incidence and risk factors for poor ankle functional recovery, and the development and progression of posttraumatic ankle osteoarthritis after significant ankle ligament injury (SALI): the SALI cohort study protocol

“…Approximately, one third of patients report residual complaints after treatment, such as pain, re-sprain, swelling, muscular weakness, plus loss of function or feelings of instability [ 2 , 6 , 9 , 16 , 19 , 22 , 23 , 40 – 42 ]. In studies where patients visited their GP after lateral ankle sprain, 47.5% of the patients experienced persistent complaints and only 17.5% regarded themselves as completely recovered [ 9 , 11 , 43 ]. Around 33% of patients experience pain 1 year after spraining an ankle [ 22 , 42 ], and 50% of patients who suffer an ankle sprain experience pain 4 years after suffering the sprain [ 44 ].…”

“…Similarly, studies with a long-term follow-up, ranging from 5 to 7 years, reported chronic complaints in 20–39% of the patients [ 22 , 45 , 46 ]. In addition to persistent complaints, individuals also have an increased risk of recurrent ankle sprain [ 9 , 41 , 47 ], for example Kreitner, et al [ 48 ] found that up to 34% of patients report at least one re-sprain within 3 years of the initial sprain.…”

“…Ankle sprains are one of the most common musculoskeletal injuries [1][2][3][4][5][6][7]. This is emphasised by research, worldwide, stating the high prevalence of ankle sprains [8][9][10][11][12]. Ankle sprains account for up to 5% of all Emergency Department visits in the UK annually, which is approximately 5600 injuries per day [4,8,[13][14][15][16].…”

“…Ankle sprains are also the most common type of ankle injury in many sports [14,[17][18][19][20][21], with about half of all reported ankle sprain injuries occurring during sports [12,22,23]. This has been stated to be about 15% of the total number of sporting injuries [9] and emphasises that ankle sprains are one of the most common injuries to occur during sport and physical activity, both recreationally and competitively [20,[24][25][26][27]. This is particularly evident in sports where participants frequently jump and land on 1 foot, make sharp cutting manoeuvres, or make contact with either a teammate or opponent, such as basketball [28,29], volleyball [30], field hockey [31], handball [32], football [33], and figure skating [34] where ankle sprains have been reported as a predominant injury.…”