Ankle Sprain Types and Impact

Introduction

One of the most common types of injuries, especially among physically active individuals is ankle sprain (Martin et al 2013). According to Wolfe et al (2001), the most common type of ankle sprain is plantar flexion and inversion, which can lead to the damage of ankle ligaments such as posterior talofibular ligaments, calcaneofibular ligament, and anterior talofibular ligaments that are responsible for lateral stability. Depending on how severe the pain is, these ligaments may be partially or completely raptured or stretched (Wolfe et al, 2001). Besides according to Martin et al (2013) Incidences of severe pain may be characterised by the injury of additional structures such as muscles, nerves and tendons, and these injuries may lead to further pain loss of function, reduced range of motion and swelling.

Upon diagnosing for ankle sprains, some of the standard care procedures that may be prescribed by physicians include compression, ice, rest and elevation, a treatment procedure popularly known as the RICE protocol. Other standard care procedures include functional rehabilitation, manual therapy, as well as weight-bearing support (Wolfe et al 2001, Martin et al, 2013). Alternatively, physicians can use oral or topical nonsteroidal anti-inflammatory drugs (NSAIDs) as supportive therapy to reduce disability, pain and swelling as well as to improve patient function.

Topical NSAIDs are often used locally to reduce pain in the short-term while reducing potential side effects such as gastrointestinal effects that may be experienced by the patient with oral NSAIDs (Niethard et al 2005; Argoff 2013). Similarly, according to (Niethard et al, 2005), topical diclofenac gel is applicable in treating pain that emanates from osteoarthritis as well as other musculoskeletal disorders including tendon, muscles, ligament and joint conditions that manifest in inflammations and pains.

Topical menthol is used to stimulate thermoreceptors leading to either warmth or cooling sensations, thereby creating an anaesthetic effect (Eccles, 1994). According to research evidence by Fang et al (2002), lipophilic menthol causes local vasodilation and can enhance skin penetration when added to analgesics such as diclofenac and tetracaine. It also enhances the analgesic effect of both agents.

Other researchers have also attempted to evaluate the economic benefits of NSAIDs as treatments of ankle sprains and found positive results. For instance, (Linde et a; (1985) conducted a study to identify the cost-effectiveness of NSAIDs for the treatment of ankle sprinkles and found it to be more cost-effective compared to the placebo. Contrastingly, research evidence also shows an increased instability in patients taking piroxicam, indicating that they might have issues with early mobilising. Nonetheless, the findings on cost-effectiveness must be compared with the drawbacks such as atrial fibrillation, impediment tissue healing and bleeding as found by 42 and 46.

There are only a few studies on the use of NSAIDs as a treatment to ankle sprinkle. The main aim of the proposed study is to determine the effectiveness of oral or topical ibuprofen in pain management for an ankle sprain.

Research objectives

To identify the effectiveness of oral or topical ibuprofen in pain management for ankle sprains.

To identify the benefits of oral or topical ibuprofen in pain management for ankle sprains.

To identify the efficacy and safety of oral or topical ibuprofen in pain management for ankle sprains.

Research Question

In clinical research, the development of a research question is an important aspect of every study because it determines the research focus and how the objectives will be achieved. Without a properly developed research question, it may be challenging to identify the resources needed to complete gather the relevant evidence (Reichardt, 2006). Therefore, in the spirit of evidence-based practice, practitioners use a framework called PICO, specifically meant to develop the research question. According to Jo (2002), PICO stands for patient, intervention, comparison, and outcome. It entails developing a research question that takes into account the particular intervention being evaluated, the target population for which the intervention is developed, a comparison of the intervention and the possible treatment outcome of the intervention. In the proposed study, the researcher will rely on the PICO framework as illustrated below:

Therefore, the main research question for the study is: What is the effectiveness of oral or topical ibuprofen in pain management for ankle sprains?

Research Methodology

The proposed study will be a randomized double-blind, placebo-controlled trial. When interested in identifying the effectiveness of an intervention, researchers are interested in determining whether the intervention is directly related to the outcome. In doing so, randomized control trials (RCT) are the most popularly. They are interventional or experimental studies used to experiment with the effectiveness of an intervention and to accurately establish whether the intervention is directly responsible for the outcomes (Tukey, 1962). Bonnell et al (2006) consider RCTs as the most convincing research designs whereby researchers randomly assign the intervention to eliminate the influence of immeasurable or unknown confounding factors that can otherwise contribute to a biased or inaccurate conclusion of treatment effects. Furthermore, according to Reichardt (2006), randomization provides an opportunity for the researcher to eliminate any confounding factors that might result from baseline variables while blinding assists in eliminating the confounding factors that might emanate from co-interventions Ultimately, the researcher is able to eliminate the possibility that observed treatment effects might be as a result of the use of other treatments differently. As part of the proposed study, the placebo control will be useful in blinding the investigators, study staff and the participants (Fisher, 1935). All in all, the reason why the proposed study selected an RCT over an observational research methodology is that the latter, as opposed to the former, can effectively demonstrate causality.

Research Method Eligible participants will randomly receive 4g of topical 3% menthol gel/1% diclofenac, 0.09% menthol gel/1%diclofenac, or 0.09% placebo menthol gel 4 times daily in an interval of four to six hours until the pain is completely resolved or for ten days, whichever occurs first. The active control in the study will be the diclofenac in the 1% diclofenac/0.09% menthol gel. Moreover, the researcher will add a subtherapeutic amount of menthol to maintain some fragrance so that the patient and investigators remain blinded to the treatment assignments.

The researcher also plans to offer some training to all the patients on the correct gel usage and to supply each patient with an applicator strip for the correct dosage. Meanwhile, the researcher will supervise the first application dose. To ensure a correct dosage, the applicator strip will contain two circles with a mark at the centre of each strip; based on which each patient will be asked to dispense the gel by squeezing the gel into the centre of each mark until the marked area is filled. This will be an equivalent of the 4g dose.

The researcher will also assign randomization numbers too each participant in ascending order while blinding both the key staff and patients to the treatment allocation. It is also important to note that the researcher intends to use the randomization criteria provided by GlaxoSmithKline Consumer Healthcare, which is often used internally and enables code identifier concealment. Meanwhile, the researcher will use a block randomization technique will be used to randomize the participants within 4 treatment categories based on the ratio of 3:3:2:2. Furthermore, the participants will be randomized following an age group and site stratification design with the fist stratum consisting of patients between 16 and 17 years old, while the second stratum will consist of patients within 18 to 65 years old.

The researcher will include a study population of age 16 to 65 years with grade one or two acute sprains of the medial or lateral ankle sprain. All the participants must have presented at the hospital within 24 hours of the injury particularly because ankle sprain has develops a PI that reduces after 24 to 48 hours. Therefore, the treatment effect is likely to be experienced within the first 24 hours after injury.

More importantly, the researcher intends to recruit participants by putting up an advertisement in medical dispensaries and pharmacies close to the anticipated centre of study as well as in sports clubs and physical activity arena within the vicinity. The researcher will also visit the nearest football game to directly recruit players who have had ankle sprain injuries.

The study will only include participants in good mental and physical health. Furthermore, the study will only include those who are willing and able to comply with the study procedures, while any female participant with a potential to bear children will be required to use a reliable contraception method. Also, the researcher will use the Ottawa ankle rules to rule out fractures (Stiell & McKnight).

Patient with grade three fractures, breast-feeding or those with acute pain disorders will be excluded. Moreover, the study will exclude patients with injury in both ankles, or those with injuries at the medial and lateral ligaments of the same ankle. The researcher will also screen the participants and exclude them if they have had surgery in the past thirty days pain emanating from recent trauma, connective tissue disease or those already in pain medications. Particularly, patients under medication were excluded to prevent interference with the validity of study outcomes.

Data Analysis

The researcher will assess the intervention’s effectiveness among the intent-to-treat participants that consisted of randomized patients who received treatment. The researcher will also conduct a sensitivity assessment for both the secondary and primary outcomes among per-protocol participants who will fully comply with the study procedures without violating the study protocol. Meanwhile, the researcher will use SPID1-3 to estimate the sample size particularly because the AUC and SPID of PI are measured similarly.

Research Paradigm

RCTs are valued research methods that enhance the concept of evidence-based practice in healthcare. In the proposed study, the researcher intends to associate the study process with an epistemological and ontological perspective situated within a positivist research philosophy (Holland, 1986). In doing so, the researcher will hold the belief that variables and environments are controllable to understand particular outcomes or to comprehend a cause-effect relationship.

Ethical considerations

With the increasing popularity of RCTs in health research, the fact that RCTs involve human subjects raises various ethical issues ranging from risk minimization to obtaining informed consent as well as protecting the participant confidentiality. Therefore, one of the ethical issues likely to be raised in the proposed study is informed consent (Angrist, 1996). In response, the researcher will develop a consent form and pass it to each participant for signing. Participants will be required to issue an informed consent after reading all the relevant information regarding the study. To protect participant privacy and confidentiality, no personal data including participant name, email address or place of residence. To ensure that participants are not exposed to any risk, the researcher will seek ethical approval from the university’s ethical committee, besides keeping close monitoring at the study process to mitigate any possible risks.

Research Strengths

The researcher will strongly rely on Critical Skills Appraisal Program (CASP) framework to ensure that it comes out with the most valid and highest quality results. For instance, to ensure that the study results are valid, the researcher has already developed a focused research question using the PICO framework. According to Jo (2002), the PICO framework enhances the focus of the study by examining whether the study has a clear identification of study population, the type of intervention given, as well as the considered outcomes. Therefore, one f the strengths of the current study are the clear development of a focused issue that will ensure that the study outcomes are valid.

According to Little & Yau (1998), the validity of RCT results also depends on whether the patients are randomly assigned to the treatment. Therefore, as earlier mentioned, the randomization process will be carried out comprehensively, based on stratification manner that conceals the whole process from researchers and participants.

Little & Rubin (2002) insists that researchers must account for all the study participants at its conclusion, or in case of an early adjournment. In the proposed study, the researcher will account for all the participants by analyzing them in the groups they were assigned to. If the study stops early, the researcher will take an account of all the participants to evaluate any confounding factor that might affect the results, as well as the reasons for the early adjournment of the study.

Study Limitations

While RCT research method is considered the most appropriate for testing the effectiveness of medical interventions West & Sagarin (2000), it may not provide all the information needed for the study. For instance, in the context of the proposed study, the RCT research design might provide adequate information on the effectiveness of oral or topical Ibuprofen in the treatment of ankle sprinkle; it might not provide critical information about the particular type of patients who might benefit most from the intervention (Rubin, 1974).

Another possible limitation of the study is the heterogeneity of the participants, which might be difficult to account for with just over 200 participants. According to Reichardt (2006), achieving statistical significant of RCT trials require large populations and therefore considering the proposed study’s sample population, the results might end up just being central tendencies and not exact measures and not a representative of anybody if looked from an individual perspective. Therefore, moving beyond the study results and applying the study results to individual patients may be a challenge. Ideally, the study will have a kind of ‘rarefied’ participants who may not be a perfect representation of the entire population in real-world situations (West & Sagarin, 2000).

Alternative Approaches to Future Research

Based on the Rubin Causal Model on potential outcomes framework, there might be a need for future research to consider alternative research designs that can enable researchers to make similarly strong inferences on interventions’ causal effects. For as opposed to the proposed study whereby participants are invited to randomly take part in treatment conditions but allowed to make a choice in whether they are interested in receiving the treatment (i.e., randomized encouragement design), future studies may adopt a qualitative assignment design whereby the treatment intervention is assigned to participants using a quantitative measure of maybe risk, merit or need. Alternatively, future studies may be purely observational, whereby the treatment procedure is presumed random.

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