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Cochrane Database of Systematic Reviews Protocol - Intervention

Interventions for the prevention and treatment of pes cavus

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To assess the effects of interventions for the prevention and treatment of pes cavus.

Background

While much attention has been given to the plight of the pathological pes planus, or 'flat foot', little is known about the other extreme in foot type, the high‐arched foot, or pes cavus. People with pes cavus frequently suffer foot pain, which can lead to significant disability. Despite anecdotal reports, rigorous scientific investigation of this condition and how best to manage it is lacking. This review examines the effectiveness of established interventions for the prevention and treatment of pes cavus.

Epidemiology of pes cavus
There are few good estimates of the prevalence of pes cavus. There has been only one community‐based study of its prevalence in the general population. An Indian study of 1,846 healthy people aged 16 to 65 years found that 10% had high‐arched feet, as assessed on static footprint (Sachithanandam 1995).

Aetiology of pes cavus
The aetiology and mechanisms underlying pes cavus are complex and not well understood. Factors considered influential in the development of pes cavus include muscle weakness and imbalance in neuromuscular disease (Burns 2005b), residua of congenital clubfoot (Pandey 2002), post‐traumatic bone malformations (Horne 1984), peroneus longus tendon laceration (Carroll 1999), contracture of the plantar fascia and shortening of the Achilles tendon (Dickson 1939).

Foot and ankle pain in pes cavus
Individuals with pes cavus frequently report foot pain, which can lead to significant disability (Badlissi 2005). The range of complaints reported in the literature include forefoot metatarsal pain and plantar heel pain (Burns 2005a), pain under the sesamoid region (Helliwell 1995), painful callosities (Aktas 2000), ankle arthritis (Fortin 2002) and Achilles tendonitis (Giannini 2002). Other symptoms believed to be related to pes cavus include shoe‐fitting problems (Aktas 2000), lateral ankle instability (Barrie 2001), lower limb stress fractures (Korpelainen 2001), knee pain (Dahle 1991), iliotibial band friction syndrome (Williams 2001) and osteoarthritis of the hip (Reilly 2006).

Interventions for the prevention and treatment of pes cavus
Successful prevention and treatment of pes cavus foot pain and associated disability is clinically challenging. While conservative and surgical approaches have been described in the literature, no firm evidence exists for any approach. Conservative management of patients with pes cavus typically involves strategies to reduce and redistribute plantar pressure loading through the use of foot orthoses and specialised cushioned footwear (Statler 2005). Other non‐surgical rehabilitation approaches include stretching and strengthening of tight and weak muscles, debridement of plantar callosities and strategies to improve balance (Manoli 2005).

There are also numerous surgical approaches described in the literature aimed at correcting and preventing the progression of the deformity by rebalancing and reconstructing the foot. Surgical procedures fall into three main groups: (1) soft‐tissue procedures (e.g. plantar fascia release, Achilles tendon lengthening, tendon transfer); (2) osteotomies or removing a wedge‐shaped portion of the bone (e.g. metatarsal, midfoot or calcaneal); and (3) bone‐stabilising procedures (e.g. triple arthrodesis, which consists of fusion of the three joints in the ankle, the talocalcaneal, talonavicular and calcaneocuboid) (Wines 2005). There are few reports of long‐term follow‐up of patients undergoing surgery for cavus foot deformities.

The evidence base of interventions for the prevention and treatment of pes cavus is currently weak. This review will be undertaken because of the complex nature of pes cavus, the apparently high incidence of pain and chronic morbidity in patients with this condition, and the limited scientific data on all aspects of its prevention and treatment.

Objectives

To assess the effects of interventions for the prevention and treatment of pes cavus.

Methods

Criteria for considering studies for this review

Types of studies

We will include all randomised and quasi‐randomised controlled trials of interventions for the treatment of pes cavus. We will also include trials aimed at preventing or correcting the cavus foot deformity.

Types of participants

We will include studies on participants of all ages who are described as having pes cavus foot deformities of any aetiology and type.

Types of interventions

Any intervention aimed at preventing or treating pes cavus. These may include but are not limited to:

  • Appliances: for example, foot orthoses, footwear.

  • Physical therapies: for example, joint range of motion exercises, muscle stretching and strengthening, electrotherapeutic modalities, debridement of plantar callosities.

  • Medications: for example, non‐steroidal, anti‐inflammatory drugs (NSAIDs), corticosteroid injections.

  • Surgery: for example, soft‐tissue and bony procedures.

Types of outcome measures

The primary outcome is the level of a quantifiable measure of foot pain, or the change in the level of pain three months after intervention. Any similarly defined outcome measure used to evaluate foot pain will also be considered. Studies with different follow‐up periods will be combined with appropriate adjustments if the assumption of steady rates of change can be justified.

The data will also be assessed three months after the intervention for:

  • Functional improvement: for example activities of daily living, disability measures.

  • Biomechanical improvement: for example kinetic, kinematic, electromyography, radiographic.

  • Health‐related quality‐of‐life.

  • Patient satisfaction.

  • Adverse effects of any treatment regime.

Again studies with different follow‐up periods will be combined with appropriate adjustments if the assumption of steady rates of change can be justified.

Search methods for identification of studies

We will search the Cochrane Neuromuscular Disease Group Register for randomised trials using the following search terms:
#1. (cavus or cavoid or cavovarus or supinated or high arch$).tw
#2. (foot deformit$ or foot malformation).tw
#3. 1 or 2

We will adapt this strategy using an appropriate combination of MeSH and text word terms, combined with the strategy to identify randomised controlled trials (Cochrane Handbook for Systematic Reviews of Interventions and the Cochrane Neuromuscular Disease Group information for authors) to search the following databases up to the current date:

  • MEDLINE from 1966;

  • EMBASE from 1980;

  • CINAHL from 1982;

  • Allied and Complimentary Medicine (AMED) from 1985;

  • Evidence Based Medicine (EBM) Reviews: ACP Journal Club (ACP) from 1991, the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews (CDSR), and the Database of Abstracts of Reviews of Effects (DARE) in The Cochrane Library, Issue 2, 2006.

  • SPORTdiscuss from 1830;

Non‐English reports will be included and we will review the bibliographies of the trials identified, contact the authors and known experts in the field and approach pharmaceutical companies to identify additional published or unpublished data.

Data collection and analysis

Study selection
Two authors (JB and KL) will independently check the titles and abstracts of the articles identified by the search. Two authors (JB and KL) will assess the methodological quality of the selected articles using a standardised grading system, and independently decide upon inclusion. Disagreements about whether a study should be included will be resolved by discussion until consensus is reached.

Assessment of methodological quality
A standardised grading system will be used to assess the methodological quality of the trials. This will take into account: secure method of randomisation, concealment of allocation, explicit inclusion/exclusion criteria, blinding (including blinding of participants, blinding of investigators, blinding of outcome assessors), how studies deal with baseline differences of the experimental groups, and completeness of follow‐up. These will be graded using the Cochrane approach: A, Adequate; B, Unclear; C, Inadequate; D, Not done.

Data extraction
Two authors (JB and KL) will extract data from the trials and write to trial authors for further information as necessary. Data will be entered into Review Manager by one author (JB) and checked by a second author (KL) using the double data entry facility.

Analysis of data
If there is more than one trial with a specific treatment or prevention approach we will calculate a pooled estimate of the treatment effect across the trials using the Cochrane statistical package Review Manager. Where possible, weighted mean differences and 95% confidence intervals (CIs) will be calculated for all continuous outcomes, and relative risks and 95% CIs will be calculated for dichotomous outcomes, using a fixed‐effect model. We will test for heterogeneity across trials, and if found, we will perform sensitivity analyses by repeating the calculation after omitting trials with low scores on individual quality items and repeat the analysis using a random‐effects model.

Subgroup analysis
If the data are available we will compare the effect of interventions in the following subgroups:

  • Age: <16 years, >16 years

  • Pes cavus aetiology: neuromuscular disease (Charcot‐Marie‐Tooth disease, myopathies such as Duchenne muscular dystrophy, neurologic conditions affecting the spinal cord such as congenitally tethered cord, conditions affecting the brain such as cerebral palsy), residua of congenital clubfoot, post‐traumatic, idiopathic.

Studies with different follow‐up periods will be presented separately to assess the effect of follow‐up period and also combined with appropriate adjustments if the assumption of steady rates of change can be justified.