To review the effectiveness of treatments for soft tissue injuries of the ankle.

MEDLINE and Excerpta Medica were searched from 1966 to 1993 for English language literature on treatment modalities for soft tissue injuries of the ankle.

Study designs of evaluations included in the review

The review included prospective and retrospective comparative and non-comparative studies. Excluded from the review were studies with small numbers of ankle injuries in treatment groups or where data could not be extracted, as well as individual case reports.

Specific interventions included in the review

Treatments were classified into pharmacological treatments (diflunisal, ibuprofen, diclofenac, proteolytic enzymes, gels/creams flurbiprofen and clonixin), surgical interventions and active mobilization (surgical repair, strapping, tenoplast, elastic, coumans, ace and dauer bandages, cast, malleotrain support, early functional treatment, compression, physiotherapy and mobilization), cryotherapy (cold, heat, contrast bath and cryotherapy), diathermy (low power short-wave, high-voltage pulsed stimulation, Diapulse, Curapuls, and pulsed electron microscopy, EM) and other treatment modalities (intermittent pneumatic compression, injection of hydrocortisone, joint aspiration, injection of lidocaine and hyaluronidase, injection of xylocaine, ultrasound, neuroprobe, ice/compression/elevation, injection of hydrchoride, sarmiento brace and casts).

Participants included in the review

The participants included patients with soft tissue injuries of the ankle. No other patient characteristics were stated.

Outcomes assessed in the review

The outcomes assessed in the review included symptoms of soft tissue injury such as tenderness, inflammation, swelling, edema, pain, stability, weight bearing and range of movement, as well as pain relief, recovery period, period of disability and patient confidence. Outcomes assessed varied between the different studies.

How were decisions on the relevance of primary studies made?

The authors do not state how the papers were selected for the review, or how many of the authors performed the selection.

The validity of the primary studies were assessed using 10 characteristics from an ideal study of treatment modalities for soft tissue injuries in sport. The characteristics assessed were: double-blinding; randomisation of patients; placebo-controlled; rigorously controlled interval between injury and beginning of treatment; stratification of injury severity; exclusion of severe injuries; assessment of benefit and harm of treatment; control for age, race, size and sex of patient; definition of objective criteria for comparison prior to treatment; and defined specific end points of treatment. The authors do not state how the papers were assessed for validity, or how many of the authors performed the validity assessment.

The authors do not state how the data were extracted for the review, or how many of the authors performed the data extraction.

How were the studies combined?

A narrative synthesis by treatment modality, using the quality criteria for assessing the validity of the studies, was undertaken. Particular attention was given to prospective, double-blind, randomised and placebo-controlled studies. No statistical comparison could be undertaken due to the lack of information on severity of condition or outcome of treatment.

How were differences between studies investigated?

Although no test for heterogeneity was presented, the variations in the quality criteria for the studies were discussed.

Of the 84 studies (7,819 patients) reviewed, 19 (1,683 patients) assessed pharmacological agents, 41 examined (4,093 patients) surgical and active mobilization, and 24 (2,043 patients) analysed physical modalities.

Pharmacological treatment, in the form of non-steroidal anti-inflammatory drugs (NSAIDs), generally offer significant improvement in recovery time and symptomatic relief over the placebo, although the studies did not highlight one particular drug as being superior. There was no evidence that proteolytic enzyme treatments resulted in improved outcomes compared to a placebo. Topical gels provided temporary relief of acute symptoms but no significant improvement in final treatment outcome.

Comparison of surgical repair, plastering, casting and active mobilization indicated a more rapid recovery through active mobilization. In general, conservative treatments produced satisfactory results in outcome.

Cryotherapy reduced pain, edema and shortened recovery period, if applied within the first 2 days following injury. Diathermy reduced pain, edema and disability following acute sprains, although to a lesser extent.

Other therapies, such as joint aspiration, injections of steroids and hyaluronidase, all proteolytic enzymes, ultrasound and intermittent pneumatic compression, had limited evidence to support their use.

Ankle injuries have a good prognosis, which is altered little by treatment. However, acute symptoms, pain and disability could be reduced by early treatment. Early mobilisation, aided by the use of bandages or strapping, provides the best results through faster recovery rates. The use of NSAIDs early on and for short periods allows early recovery, but with limited change in outcome. Cryotherapy provides similar effects as NSAIDs. Diapulse diathermy improves recovery time and symptom relief. Surgery did not significantly improve outcome.

The review sets out to provide an evaluation of treatments of soft tissue injuries of the ankle. Unfortunately, certain weaknesses in the review indicate, as the authors state, that 'one must be cautious not to prepare widespread, generalising conclusions on the basis of these results'. Problems associated with the rigour of the methodology and other specific weaknesses of the review are outlined below.

The review provided limited criteria for inclusion of patients, other than those having suffered from a soft tissue injury to the ankle. Characteristics about the patient were not provided for the studies included in the review.

No specific list of outcomes is stated within the review, other than those contained within the tables summarising the included studies. This may reflect the diversity in the underlying nature of the included studies, a problem outlined by the authors, which affects their comparability.

While the review outlines the study designs included, it provides no information on differences in length of treatment or follow-up. The study notes the problems of publication bias and the importance of including negative as well as positive results, yet does not extend its search outside published literature from MEDLINE and Excerpta Medica databases. The literature search should include knowledge of experts, drug company data and other sources of unpublished research.

The validity of primary studies included within the review were judged through a 10 characteristic quality score of an ideal study. Whilst the quality score provided a good measure for comparison, limited information was provided on the method of application of the criteria and the subsequent role it played in the authors' conclusions. Similar problems exist over the application of inclusion criteria and data extraction processes, with no information provided on the methodology used (such as independent assessment, blinding, intention to treat and drop-out rates).

Although the review provides a tabular analysis of the included studies by modality of treatment and study design, it lacks some important information such as treatment effects, confidence intervals and drop-out rates. These would have aided interpretation of the authors' results and conclusions.

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.