Acupuncture for treating acute ankle sprains in adults
Abstract
This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:
To assess the effects (benefits and harms) of acupuncture for the treatment of ankle sprains in adults.
Background
Description of the condition
An acute ankle sprain is an acute injury of one or more of the ankle ligaments, which are tough strands of tissue that connect and stabilise the bones at the ankle. The most common mechanism of injury, which results in damage to the outer or lateral ankle ligaments, is inversion (internal rotation) of a plantar‐flexed foot (toes on ground and heel up) (Wolfe 2001).
Ankle sprain is one of the most common musculoskeletal injuries in the general population as well as in athletes (Junge 2009). Waterman et al reported an incidence of ankle sprain in the US of 2.15 per 1000 person‐years (Waterman 2010). The higher annual incidence in athletes (about 7 sprains per 1,000 person‐years) reflects that ankle sprain is generally related to athletic activities (Beynnon 2001; Holmer 1994).
According to the severity of the injury, sprains can be divided into three grades: Grade 1 is a mild overstretching or slight tearing of a ligament that results in pain but with no major loss of function; grade 2 is incomplete tearing of a ligament with pain and some loss of function; and grade 3 indicates a complete rupture usually accompanied by severe pain and bruising, swelling and loss of function (Litt 1992). Physical and possibly radiological examinations are needed to evaluate the severity of the injury. To detect ruptures of ankle ligaments, delayed physical examination four to five days after ankle trauma may be more accurate than assessment of the acute stage (within 48 hours) (van Dijk 1996;van Dijk 1999). Aiming to avoid unnecessary radiological examination, the Ottawa ankle rules are increasingly used to rule out foot or ankle fractures (Stiell 1994).
The primary goal of the management of an acute ankle sprain is to reduce the swelling and pain. The PRICE technique (Protection, Rest, Ice, Compression and Elevation) is usually recommended for this purpose. Ice may reduce the local tissue temperature, which reduces swelling, inflammation and pain (Knight 1995). Compression and elevation limit the effusion of extracellular fluid and thus reduce swelling. Plaster cast immobilisation of the affected limb is one of the most used conservative treatment options. However, recent systematic reviews have reported that, compared with immobilisation, functional treatment, a program of early mobilisation along with external support generates more favourable results than immobilisation (Kerkhoffs 2002). Surgical intervention, involving ligament repair or reconstruction, is often used to treat more severe ankle injuries. Though surgery is an effective way to reduce joint instability, there is no compelling evidence that surgery is superior to conservative management (Kerkhoffs 2007).
Description of the intervention
Acupuncture is an intervention that stimulates specific points on the body surface, generally using needles. It has been used for over 2000 years in eastern Asian countries such as China and Korea (Veith 2002). Traditional acupuncture is applied according to the various concepts of the balance of Yin and Yang, Qi theory, five element theory, meridian theory and traditional diagnostic methods of oriental medicine. Recently, acupuncture has been reinterpreted and is used increasingly as 'western medical acupuncture'; this revised technique is based on the knowledge of neurophysiology and scientific methodology (White 2009).
Various kinds of acupuncture exist. Acupuncture is a wide‐ranging concept of a specific treatment method that stimulates acupuncture points with or without needling. Acupuncture includes traditional manual acupuncture, western acupuncture, electro‐acupuncture, non‐penetrating acupuncture point stimulation (e.g. acupressure), and moxibustion.
How the intervention might work
For treating ankle sprain, acupuncture is used as a single treatment or a secondary intervention accompanied by standard medical treatment (e.g. PRICE technique or physiotherapy), which depends on the clinical situation (Li 2008; Park 2004). Acupuncture is thought to generate analgesic effects through the local, segmental and central regulation of anti‐pain mechanisms (White 2008). In addition, it has been suggested that acupuncture modulates the anti‐inflammatory response and the recovery of soft tissue injuries (Li 2009; Zhang 2005). In particular, specific manipulation techniques, e.g. winding of acupuncture needles, may be relevant to the cytoskeletal remodelling of connective tissue fibroblasts, which can contribute to the healing of the ligament injury (Langevin 2002; Langevin 2006).
Why it is important to do this review
Ankle sprains are very common and acupuncture is frequently used in their treatment in some countries. For instance, according to the Korean National Health Insurance Statistical Yearbook 2008, sprains ranked as the third most common cause for visits to Oriental Medicine (OM) clinics. In Korea, approximately twice as many patients visit OM clinics for sprains than conventional clinics (National Health Insurance Corporation 2009). However, the efficacy of acupuncture for treating ankle sprains remains uncertain. Thus a critical examination of the evidence for the use of acupuncture for ankle sprains is warranted.
Objectives
To assess the effects (benefits and harms) of acupuncture for the treatment of ankle sprains in adults.
Methods
Criteria for considering studies for this review
Types of studies
Randomised and quasi‐randomised (method of allocating participants to a treatment which is not strictly random, e.g. by date of birth, hospital record number or alternation) controlled trials will be included. All studies of ankle sprains will be considered eligible for inclusion regardless of the reported method of diagnosis. Crossover studies will be excluded.
Types of participants
Adults with acute ankle sprains, irrespective of the method of diagnosis, will be included. Studies including children only will be excluded. Mixed population studies including adults and children or people with acute and chronic injuries will be included, provided the majority of the trial participants are adults with acute ankle sprains. In these circumstances, we will seek separate data for the target population.
Types of interventions
All types of acupuncture practices, including needle acupuncture, electro‐acupuncture, laser acupuncture, pharmaco‐acupuncture, non‐penetrating acupuncture point stimulation (e.g. acupressure and magnets) and moxibustion, will be included.
There will be two main comparisons.
1. Acupuncture versus no treatment or placebo (e.g. sham acupuncture). Acupuncture can be provided as the only treatment or in conjunction with other 'standard' treatment, as long as the same standard treatment is provided to both groups. 'Standard' treatment interventions include the components of the PRICE technique, non‐surgical physical interventions such as cast immobilisation, taping, bracing and other functional treatment, physiotherapy, drugs (e.g. oral and topical non‐steroidal anti‐inflammatory drugs (NSAIDS)).
2. Acupuncture versus another non‐surgical intervention (as described above). Again, acupuncture can be provided as the only treatment or in conjunction with other standard treatment, as long as the same standard treatment is provided to both groups with the exception of the comparator intervention.
Types of outcome measures
Primary outcomes
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Patient‐reported assessment of function, e.g. ankle activity score (Halasi 2004), Tegner activity level (Tegner 1985), Kaikkonen functional scale (Kaikkonen 1994), Karlsson ankle function score (Karlsson 1996), Olerud and Molander ankle score (Rose 2000).
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Cure rate (the ratio of the number of cured patients with acute ankle sprains to the number of included patients: cure means improvement in both of the clinical symptoms such as pain and swelling of the ankle joint and recovery of ankle function to return to the patient's pre‐injury health status)
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Adverse events related to acupuncture treatment (short‐term event), e.g. severe nausea, fainting, dizziness and vomiting, unexpected and prolonged aggravation of existing problems, emotional reactions, prolonged pain and bruising, and infection (MacPherson 2001)
Secondary outcomes
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Recurrence of ankle sprain, subsequent surgery or long‐term treatment
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Pain (both types of data will be analysed: dichotomous data (e.g. yes or no) and continuous data (e.g. visual analogue scale results or analgesic consumption))
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Ankle instability: either subjective (e.g. giving way), or objective (e.g. talar tilt, anterior drawer test, inversion stress test, postural sway analysis)
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Patient‐rated quality of life, e.g. the SF‐36 health survey
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Swelling (both types of data will be analysed: dichotomous data (e.g. yes or no) and continuous data (e.g. visual analogue scale results)
Timing of outcome measurement
We will consider both short‐term (within four weeks from injury) and longer‐term outcomes.
Search methods for identification of studies
Electronic searches
We will search the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (to present), the Cochrane Central Register of Controlled Trials (The Cochrane Library current issue), MEDLINE (1950 to present), EMBASE (1980 to present), China National Knowledge Infrastructure databases (CNKI) (1994 to present), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1937 to present), the Allied and Complementary Medicine Database (AMED) (1985 to present), Science Links Japan (J‐East) (1996 to present) and Korean Medical databases (Korean Studies Information, DBPIA, Korea Institute of Science and Technology Information, Research Information Centre for Health Database, Korean National Assembly Library, and Korean Traditional Knowledge Portal). We will also search the World Health Organization International Clinical Trials Registry for ongoing and recently completed studies. No restrictions will be applied based on language or publication status.
Search strategies for The Cochrane Library and MEDLINE are shown in Appendix 1. These strategies will be modified for use in other databases.
Searching other resources
The bibliographic references of all included trials will be reviewed to identify other relevant studies. Unpublished conference proceedings (e.g. Korean Acupuncture & Moxibustion Society of Korea (1995 to present), the Korean Academy of Oriental Rehabilitation Medicine of Korea (1995 to present)) and internal reports relevant to this subject will be reviewed if possible.
Data collection and analysis
Selection of studies
Two review authors (Kim T‐H and Kang JW) will independently review all identified trials to assess their eligibility for inclusion. Disagreements will be discussed and resolved, if necessary, by the other authors.
Data extraction and management
Two review authors (Kim T‐H and Lee MS) will extract data from the selected reports or studies by independently filling in a common predefined data collection form. Any disagreement will be resolved by discussion or where necessary, by arbitration by a third author (Ernst E). The following characteristics of the reports or studies will be extracted: study design, duration of the study, trial setting, ethical approval, demographic data of participants (age, sex, country and ethnic group), total number of randomised to the acupuncture and control groups, grade of sprain, the number of drop‐out participants, details of acupuncture treatment (type of acupuncture, combination treatments, acupuncture points used, frequency), control interventions and all of the relevant outcomes. The corresponding authors of the included trial reports will be contacted where there are missing data.
Assessment of risk of bias in included studies
According to the recommendations of The Cochrane Collaboration (Higgins 2008), the risk of bias will be assessed for each included study. The following domains will be evaluated for risk of bias: sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, incomplete outcome data, selective outcome reporting and other sources of bias (seeAppendix 2). Because it is difficult to develop a perfect placebo control that can blind both the acupuncturist and the participants, double‐blind clinical trials are rarely realisable in acupuncture studies (MacPherson 2008). Therefore, it is necessary that the key outcome assessment should be conducted by blinded participants and blinded outcome assessors for acupuncture research. So we will judge as low risk in the blinding domain if participants or outcome assessors were blinded properly. We will try to contact the authors of included studies if there are any unclear details for assessment of the risk of bias. The review authors will judge the risk of bias for each domain as follows: 'yes' for low risk, 'no' for high risk or 'unclear' for unclear or unknown risk based on the criteria listed in Table 8.5c in the Cochrane Handbook (Higgins 2008).
Measures of treatment effect
After all of the treatment effects of acupuncture are compared with the matched control interventions in each trial, summary statistics for the treatment effects will be calculated for each study. For dichotomous data, treatment effects will be presented as risk ratios (RRs) with 95% confidence intervals (CIs). For continuous data, mean differences (MDs) will be used for the measurement of the treatment effect with 95% CIs. Where there are different scales of outcome variables, standard mean differences (SMD) will be used with 95% CIs.
Unit of analysis issues
Only data from simple, parallel group designed trials will be included in the meta analyses. If there are any studies which have multiple observations for outcome variables, time frames of included studies will be classified as short‐term (within four weeks) and long‐term (over four weeks) follow‐up and meta analysis will be conducted respectively.
Dealing with missing data
We will request missing data from the original study investigators, whenever possible. If missing data, which cannot be explicitly determined from the original authors, are detected, we will make the assumption that these outcomes are classified as treatment failures and only the available data will be analysed initially. Where possible, a sensitivity analysis will be performed to test this assumption and the potential impact on the findings discussed.
Assessment of heterogeneity
Visual inspection of the forest plot and the chi‐squared test with a level of significance of P < 0.1 will be used for the assessment of heterogeneity between different studies. For quantifying inconsistencies between included studies, the value of I2 will be calculated. If there is substantial heterogeneity in the primary outcomes between studies (provisionally including I2 > 50%), the sensitivity and subgroup analysis described below will be conducted to identify possible factors contributing to heterogeneity (Deeks 2008).
Assessment of reporting biases
To detect reporting biases, funnel plots will be drawn using Egger's method if more than 10 studies are included in an individual analysis (Egger 1997). We will consider whether asymmetry indicates a possible reporting bias.
Data synthesis
Initially, meta‐analysis will be conducted according to the fixed‐effect model and 95% confidence intervals. In case of substantial heterogeneity which cannot be explained readily, we will look at the results using a random‐effects model.
Subgroup analysis and investigation of heterogeneity
If available, subgroup analysis will be conducted according to the severity of the ankle sprain (grade 1, 2 or 3), and the type of acupuncture intervention (including manual acupuncture, moxibustion, and electroacupuncture), and type of control intervention (placebo/sham acupuncture versus no treatment).
Sensitivity analysis
If there is a sufficient number of retrieved trials, sensitivity analysis will be conducted to show that our systematic review is robust with respect to the selection of the statistical method (the random‐effects model and the fixed‐effect model), analysis related issues (e.g. the assumptions about missing outcomes) and to the influence of trials, which have different sample sizes (small studies versus large studies), different methodological qualities, such as sequence generation, allocation concealment and blinding and different diagnostic criteria for ankle sprains, on the estimates of the overall effects on key outcomes.
Summarising and interpreting results
We will use the GRADEpro 3.5 tool for creating 'Summary of Findings' tables. This table will contain key information about the quality of evidence, the magnitude of effect of the interventions examined and the sum of available data on the primary outcomes of patient‐reported assessment of function, 'cure rate' and adverse events related to acupuncture treatment and on the secondary outcomes of recurrence of ankle sprain, pain and ankle instability from the included studies in the comparison (Schünemann 2009).
