A systematic review of early rehabilitation methods following a rupture of the Achilles tendon

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1 Physiotherapy 98 (2012) Systematic review A systematic review of early rehabilitation methods following a rupture of the Achilles tendon Rebecca S. Kearney, Katie R. McGuinness, Juul Achten, Matthew L. Costa Warwick Orthopaedics, Clinical Sciences Research Institute, University of Warwick, University of Warwick, Coventry, CV2 2DX, United Kingdom Abstract Objectives Rupture of the Achilles tendon is a debilitating injury. Advances have led to the development of immediate weight bearing rehabilitation. A range of early rehabilitation methods exist, but further research is required into this new area. The first stage in the investigation of a complex intervention is to identify its defining components. The aim of this review was to systemically identify and summarise, from clinical studies, the individual components that define immediate weight bearing rehabilitation protocols for the treatment of acute Achilles tendon rupture s. Data sources The electronic databases MEDLINE, EMBASE, CINAHL, AMED and the register of current controlled trials were searched up to March Review methods All study designs and languages were included. Two independent reviewers used pre-defined inclusion and exclusion criteria to identify all eligible articles. Eligible articles were summarised and critically reviewed, using the extension of the CONSORT statement for non-pharmacological interventions. Results Two hundred and fifteen articles were screened, nine were included. These studies, presented the results of 424 patients; 236 who had and 188 who were managed non-operatively. There were a range of rehabilitation protocols that were defined by four components. These components consisted of the degree of maintained plantarflexion, whether daily range of movement exercises were permitted, the type of orthotic and for how long it was worn. Conclusions The efficacy of different immediate weight bearing rehabilitation protocols following an acute rupture of the Achilles tendon remains unclear. Further research is required to evaluate the identified components to optimise rehabilitation Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved. Keywords: Achilles tendon; Rupture; Rehabilitation; Physical therapy modalites Background Rupture of the Achilles tendon affects 18 per people each year and its incidence is rising [1]. This common injury has a bi-modal distribution. The first peak predominantly affects males aged years and the second predominantly affects women aged years [2]. It is a debilitating injury, resulting in prolonged rehabilitation [3]. Many methods of rehabilitation for this injury have existed. Traditionally, these have involved immobilisation within a plaster cast. More recent research has led to newer methods of rehabilitation, specifically immediate weight bearing and early movement within an orthotic Corresponding author. Tel.: address: r.s.kearney@warwick.ac.uk (R.S. Kearney). [4]. The benefits of immediate weight-bearing compared to non-weight-bearing rehabilitation have been consistently documented within the literature by randomised controlled trials and meta-analysis [4 6]. They include, not only decreased complication rates, such as re-rupture, but also the functional benefits of being able to bear weight on the affected limb, which is of particular importance for older patients [7]. The early management of patients with a rupture of the Achilles tendon is therefore of direct relevance to both medically trained professionals and the physiotherapists who guide the patients rehabilitation. Through collaborative multidisciplinary working to identify optimal early management strategies, the later rehabilitation stages may be simplified and indeed made easier for patients. A complex intervention is defined as a treatment that involves several interacting components [8]. This has been /$ see front matter 2011 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved. doi: /j.physio

2 R.S. Kearney et al. / Physiotherapy 98 (2012) acknowledged within current reviews of Achilles tendon rupture management, including a Cochrane review. This review discussed that there are many methods of immediate weight bearing rehabilitation and that further research is required into this new and emerging area [5]. The processes involved in the development of a complex intervention have been outlined by the Medical Research Council, in a guide entitled developing and evaluating complex interventions [8]. This guide highlights the importance of identifying and defining the individual interacting components that form the complex intervention from the current evidence base. Defining the interacting components then provides a platform from which to develop this new area of rehabilitation. Therefore the aim of this review was to identify and define the key components of a rehabilitation strategy for patients with a rupture of the Achilles tendon. Objectives To systemically identify and summarise, from clinical studies, the individual components that define immediate weight bearing rehabilitation protocols documented within the literature for the treatment of patients with an acute rupture of the Achilles tendon. Methodology Data sources The primary search employed the electronic databases of Medline (1950 to March 2010), AMED (1985 to March 2010) and EMBASE (1980 to March 2010), searched via Ovid. Additionally CINHL (1981 to March 2010) was searched via EBSCO Host. The search strategy can be found within Table S1 and was carried out 28/03/10. No prior protocol was published. A secondary search assessed unpublished literature using the register of current controlled trials database for recently completed trials ( A hand search was also undertaken using the reference lists of review papers that were evaluated to identify any additional relevant articles. Relevant experts in the field were also contacted where further clarification was required. Eligibility criteria All study designs and languages were included and translated where necessary. The review included all patients aged over 18 years with an isolated, primary acute rupture of their Achilles tendon. An acute rupture was defined as being less than 14 days old [9]. Articles reporting subjects presenting with delayed presentation (over 14 days), re-rupture or previous Achilles tendon were excluded. All articles had to document an immediate full weight bearing, functional bracing protocol. Immediate weight bearing was defined as allowing weight bearing within the first week from presentation. Patients treated with operative or non-operative management were included. The minimum information required to define a protocol consisted of which functional brace was worn, how long it was worn for and what degree of plantarflexion was permitted. The authors of any articles that did not contain these minimum criteria, but did mention an immediate weight bearing functional bracing protocol, were contacted for further information. If the authors were unable to provide further information the article was excluded. Study appraisal and synthesis method Trials were independently assessed for inclusion by two reviewers (RK and KM). The reviewers evaluated all identified titles and abstracts independently and excluded any clearly irrelevant articles at this point. The full texts of all remaining articles were assessed against the eligibility criteria. Differences were resolved by discussion. Studies deemed eligible were then reviewed for methodological quality pertaining to the reporting of complex interventions. These recommendations for minimum reporting criteria were defined by the consort statement extension for reporting complex interventions. This score consists of three components. The first, relates to whether or not the authors have reported a description of the different components of the intervention. The second, details how the interventions were standardised and the third relates to the adherence of care providers with the protocol [10]. In addition to quantifying the quality of reporting the interventions, data was then extracted to summarise the interacting components that constituted an immediate weight bearing rehabilitation protocol. This was done by a single reviewer (RK) and verified by the second reviewer (KM). The principal measure for this review was the identification of the individual components that define an immediate weight bearing protocol. The clinical outcomes in relation to these protocols will be described. However, due to the heterogeneity of the principle measure, the clinical results of the studies could not be combined. Results Search strategy The results of the databases searched were combined and, once duplicates were removed, 215 articles were screened for eligibility. A summary of the search results can be found in Fig. 1. One hundred and eighteen articles were excluded based upon title and abstract information. Ninety-seven full text articles were assessed against the eligibility criteria. Of the 97 full text articles, one foreign-language article was

3 26 R.S. Kearney et al. / Physiotherapy 98 (2012) records identified through database searching (MEDLINE, AMED, EMBASE and CINAHL) Unpublished literature: 0 of these patients was years of age. They included 155 men and 33 women. 215 records after duplicates removed and subsequently screened 118 articles excluded based on title and abstract (9:letters, 25:Not IWB, 84: Not Acute TA rupture) 97 Full text articles ordered and assessed for eligibility: 63: Did not fulfil intervention criteria 7: Did not fulfil population criteria 10: Reviews of Achilles tendon management 8: IWB, but cast immobilisation 1: British Library unable to obtain 8: Included 1: Text added from reference list 9: Total included in review Fig. 1. Flow chart of study selection, following PRISMA recommendations. un-obtainable from the British library. Therefore 96 articles were assessed. Of these 96 articles 15 were non-english and translated (CE and PF). Ten of the 96 articles were reviews of overall management for Achilles tendon ruptures. These were excluded but their reference lists were checked for potentially eligible articles. Sixty-three of the 96 articles were excluded for not using an immediate weight bearing intervention. A further seven were excluded for including a sample who had not sustained an acute Achilles tendon rupture. Eight articles used immediate weight bearing but within a below knee cast, and were also excluded. This resulted in eight included articles from the original 96. In addition, one other eligible paper was found within the reference list of a screened article [6,11 18]. Table 1 shows a summary of the included articles and description of the individual components that form the immediate weight bearing rehabilitation protocol. The first report of an immediate weight bearing functional bracing rehabilitation, was published by Speck and Klaue in 1998 [12]. Participants The literature presented findings of 236 patients presenting with an acute, unilateral, rupture of the Achilles tendon which were treated operatively, with immediate full weight bearing rehabilitation in a functional brace. The age range of these patients was 18 years through to 83 years. They included 135 men, 25 women and 76 were not specified. The method of was described as open in 98 cases, minimally invasive in 25 cases, percutaneous in 76 cases and not detailed in 37 cases. One hundred and eighty-eight patients presented with acute, unilateral, rupture of the Achilles tendon which were treated non-operatively, but also with immediate full weight bearing rehabilitation in a functional brace. The age range Intervention components Of the 236 patients who had, 51 were managed in an in-shoe flexible dorsum carbon fibre orthotic, 143 were managed with a rigid rocker bottom style orthotic and 42 were managed with tape bandage. Weight bearing was allowed immediately in 155 patients, within two days for 39 patients and within one week for 42 patients. Sixty-two of these patients wore their orthotic for three weeks, 160 wore them between six and eight weeks and 14 wore them for three months. While wearing the orthotic, the 236 operatively managed patients were maintained within a range of fixed plantarflexed positions. One hundred and eighteen patients were maintained in neutral throughout with restriction to dorsiflexion only, 42 patients had a 2 cm heel raise inserted within the orthotic and 76 had three heel wedge inserts. These degrees of fixed plantarflexion were gradually reduced at equal intervals in all cases. Only one study, consisting of 42 patients advised patients not to remove the orthotic throughout the period of rehabilitation. Of the 188 patients managed non-operatively, 147 patients were managed with an in-shoe flexible carbon fibre orthotic, 41 were managed with a rigid rocker bottom style orthotic. Weight bearing was allowed immediately for 22 patients, within three days for 125 patients and after one week for 41 patients. One hundred and forty-seven patients wore their orthotic for eight weeks and 41 wore theirs for six weeks. While wearing the orthotic, 22 patients were maintained in plantarflexion with three 1.5 cm heel raises, 125 patients were maintained with a 3 cm heel and 41 at 30 plantarflexion. These were gradually reduced at regular intervals in all cases. Only one study consisting of 41 patients advised patients not to remove their orthotic throughout the period of rehabilitation. Outcomes and complications All patients were followed up for a minimum of six months and a maximum of 6.5 years. A range of outcome measures were used to evaluate the interventions including return to sport, return to walking, return to work, return to stair climbing, ultrasound, strength, range of movement, calf circumference, pain, satisfaction, American Orthopaedic Foot and Ankle Score, EQ-5D and Leppilahti score. This range reflects the lack of validated outcome measures for this injury and subsequently makes direct comparisons impossible. Although the functional outcomes are heterogeneous across the included studies, reporting of complications is not. Of the 236 patients who had, there were six cases of tendon re-rupture, two cases of delayed healing, four sural nerve injuries, three cases of scar adhesions, two skin complaints, six cases of tendon lengthening, one deep vein thrombosis and one case of complex regional pain syndrome.

4 Table 1 A summary of the characteristics of the included studies and the complex intervention components. Paper Sample size Study design/question Population characteristics Immediate weight-bearing intervention Speck 1998 [12] 20 Case series Operative (open) 15 men, 5 women years No previous rupture or Costa 2003 [13] 14/group RCT (Brace vs NWB Cast) Costa 2006 [6] 23 IWB operative 25 NWB cast operative 22 IWB non-operative 26 NWB cast non-operative 2 RCTs (1) IWB vs NWB Cast Op (2) IWB vs NWB Cast Non-op Operative (any) 24 men, 4 women Over 18 (average 41 years) (1) Operative (any) years Surgery (2) Non-operative years Surgery Rigid rocker 6 weeks Neutral WB day 1, ankle exercises 4 times/day Flexible carbon fibre 8 weeks Three 1.5 cm heel raises, One raise removed every 2 weeks WB day 1 Flexible carbon fibre for both 8 weeks (operative) 12 weeks (non-operative) Three 1.5 cm heel raises One raise removed every 2 weeks (operative). No change for first six weeks followed by above protocol (non-operative) Both groups WB day 1 Follow-up, outcomes and authors conclusions 6 weeks and 3, 6 and 12 months Own scoring system, ultrasound, strength 1 DVT IWB is safe. All returned to normal 6 months. 2, 4, 6, 8 weeks and 3, 6, and 12 months Calf muscle bulk, ultrasound, return to sport, strength 1 re-rupture, 1sural nerve deficit, 1 delayed healing. IWB safe, return to sport 6 months (2 months sooner than cast group). 3, 6, and 12 months Return to sport, walking, work, stair climbing, EQ-5D and strength 2 re-ruptures (operative group) 1 poor healing and 1 re-rupture (non-operative) group IWB is safe and results in better functional outcomes within operatively managed patients compared to plaster cast. IWB is safe within non-operatively managed patients, but did not result in better functional outcome measures compared to a cast group. R.S. Kearney et al. / Physiotherapy 98 (2012)

5 Table 1 (Continued ) Paper Sample size Study design/question Population characteristics Immediate weight-bearing intervention Hufner 2006 [18] 125 Case series Non-operative (10 mm or less gap) 105 men, 20 women Over 18 (20 70 years) Jacob 2007 [14] 36 Case series Operative (open) Over 18 Majewski 2008 [15] 14 matched pairs Case controlled series (NWB Cast vs IWB) Metz 2008 [16] 41 non-operative 42 operative RCT (Operative vs Non-operative IWB) Operative (percutaneous) 13 men and 1 women Over 18 (25 62 years) No previous or injury Operative (open) and non-operative Over 18 (23 63 years) Flexible orthotic design 8 weeks 3 cm elevation of heel 3 days in cast, exercises out of boot at 4 weeks, 1 cm heel rise within their shoe for 3 months. Rigid rocker 6 8 weeks Neutral WB day 1 Shoe, with anterior, medial and lateral support, high shaft. 3 months 3 cm heel wedge, removed gradually between weeks 4 7. Stabilisers removed 7 weeks. Day one: Splint to hold the foot in 20 degrees of plantar flexion then orthotic. Operative: tape bandage Non-operative: rigid rocker Both 6 weeks Operative: 2 cm heel rise Non-operative: 2 weeks 30, 2 weeks 15, 2 weeks neutral. Both had cast for one week Both not allowed to remove Follow-up, outcomes and authors conclusions Not specified. Ultrasound, strength, return to sport 3 DVTs, 2 soft tissue discomfort, 8 re-ruptures, 21 lengthened tendons Poor compliance caused complications. Otherwise IWB is safe. Minimum years Calf circumference, strength, pain, walking limp and satisfaction None IWB is safe and should be standard. 12 months Hannover Achilles tendon score, return to work, return to sport, strength, pain, ROM, calf circumference. 6 lengthened tendons in shoe group, 5 in cast group. Earlier return to work and sport within the shoe group. IWB is safe. 1,3,5,7 weeks and 3 and 6 months Leppilahti score, ROM, strength. Non-operative: 5 re-ruptures, 1 sural nerve injury, 1 DVT, 13 skin complaints Operative: 3 re-ruptures, 3 sural nerve injury, 1 complex regional pain, 2 skin complaints, 3 scar adhesions. No functional differences between the two groups. Less risk of complications within the operative group. 28 R.S. Kearney et al. / Physiotherapy 98 (2012) 24 32

6 Bhattacharyya 2009 [17] 34 NWB 25 IWB 2 consecutive case series (IWB percutaneous vs NWB open repair) Operative years Doral 2009 [11] 62 Case series Operative (percutaneous) Over 18 (27 38 years) No previous or injury Rigid rocker 8 weeks 3 heel rises, reduced every two weeks. Cast immobilisation for a couple of days first. Rigid Rocker 3 weeks Neutral WB Day 1, daily exercises, resistance exercises from week 6, jogging week 10. IWB: immediate weight-bearing; WB: weight bearing; NWB: non-weight-bearing; range of movement; AOFAS: American Foot and Ankle Score; DVT: deep vein thrombosis. 3,6, and 12 months Return to normal activities as reported by the patient, return to sport, work and walking. None in the IWB group IWB safe and resulted in faster return to normal activities when compared to the cast group. 2, 6, 12, 24 weeks and 12 months Calf circumference, ROM, return to sport and work, AOFAS, strength. None Calf atrophy is the biggest problem. Authors concluded this rehabilitation programme is safe. R.S. Kearney et al. / Physiotherapy 98 (2012)

7 30 R.S. Kearney et al. / Physiotherapy 98 (2012) Table 2 Summary of complex intervention reporting from the included studies. Paper Description of components (Y/N) Details standardisation (Y/N) Details of adherence (Y/N) Speck 1998 [12] Y N N 1 Costa 2003 [13] Y N N 1 Costa 2006 [6] Y N N 1 Hufner 2006 [18] Y N N 1 Jacob 2007 [14] Y N N 1 Majewski 2008 [15] Y N N 1 Metz 2008 [16] Y N N 1 Bhattacharyya 2009 [17] Y N N 1 Doral 2009 [11] Y N N 1 Total score (max: 3 points) Of the 188 patients managed non-operatively, there were 14 re-ruptures, four deep vein thromboses, 21 cases of tendon lengthening, two cases of persistent discomfort in the region of the injury, one sural nerve deficit and 13 skin complaints. In relation to the specific components of the immediate weight bearing protocols (regardless of operative or nonoperative management). There were six re-ruptures, one sural nerve injury, one DVT and 13 skin complaints in patients managed with a rigid rocker bottom style orthotic. Within the carbon fibre flexible orthotic group there were 14 re-ruptures, two cases of delayed healing, four sural nerve injuries, three scar adhesions, two skin complaints, 27 cases of tendon lengthening, four deep vain thrombosis, one case of regional pain syndrome and two cases of persistent discomfort. Regarding the length of time the orthotic is worn for, the least duration of three weeks reported no complications, the longest duration of three months reported six lengthen tendons and the remainder of the complications occurred within patients managed for a duration between six and eight weeks. These were 20 re-ruptures, two delay healing, five sural nerve injuries, three scar adhesions, 15 skin complaints, 21 cases of tendon lengthening, five deep vein thrombosis, one regional pain syndrome and two cases of persistent discomfort. Finally, the three articles which described the immediate use of a plantar-grade foot position reported one DVT. The remainder of the complications were reported within patients managed with a degree of maintained plantarflexion, which included 20 re-ruptures, two delay healing, five sural nerve injuries, three scar adhesions, 15 skin complaints, 27 cases of tendon lengthening, four deep vein thrombosis, one regional pain syndrome and two cases of persistent discomfort. Critical appraisal of intervention reporting Table 2 illustrates the quality of reporting for each of the nine included studies. All nine articles did fully describe the intervention components. However, none of the nine articles described any aspects of standardising the administration of the intervention or described adherence to its implementation. Methods of standardising the administration of the intervention could have included written instructions or a documented training programme. Methods of reporting adherence to the intervention include videoing the application of the intervention for independent review, or using case report forms which explicitly ask if the planned intervention had been adhered to. Discussion The Medical Research Council advises that some interventions, such as rehabilitation, have several interacting components [8]. The starting point for the development of a complex intervention is to identify and define the individual interacting components from the current evidence base. This systematic review was designed to identify these components within the context of immediate weight bearing rehabilitation of patients with a rupture of the Achilles tendon. Animal models have consistently shown the detrimental effects of immobilisation on both tendon and muscle tissue, following division of the Achilles tendon.[19 22] Conversely, they have also demonstrated the potential benefits of early movement and controlled loading. Benefits include improved tendon characteristics through maturation and orientation of collagen fibres and decreased muscle atrophy. In 1998 Speck and Klaue [12] were the first to put theory into clinical practice with their case series of 20 patients. There have been eight subsequent publications that have demonstrated the clinical safety of immediate, weight bearing rehabilitation. None of the articles directly compared different methods of immediate weight bearing rehabilitation. This review identified four individual components that define an immediate weight bearing protocol. The first component was the design of orthotic that was worn. Two broad designs were used; these were flexible, in-shoe carbon fibre orthotics and a rigid rocker-bottom style orthotics. Of the included articles five used of the rigid-rocker bottom style orthotic and four used the in-shoe carbon fibre orthotic. The second component was the degree of plantarflexion, which ranged from none (plantar-grade) through to a 4.5 cm heel raise. Within this review, three of the articles maintained no plantarflexion, with three articles at the other extreme. The third was how long the orthotic was worn, which ranged from three weeks in one article, to three months also in one article, but the majority were worn for between six and eight weeks. The fourth was whether to allow daily range of movement exercises, which was allowed in all but one study.

8 R.S. Kearney et al. / Physiotherapy 98 (2012) The above summarises the principle components identified within immediate weight bearing protocols and the variations that exist within the literature to date. This has direct implications for not only the direction of future research, but also the clinical team responsible for the management of this injury. Specifically, within the context of physiotherapy a key issue is atrophy of the gastroc-soleus complex and consequent gait abnormalities. Optimal immediate weight bearing rehabilitation within an orthotic may limit muscle atrophy. However, progression of the rehabilitation needs to be balanced against the clinical risks of re-rupture and tendon lengthening [7,23]. Tendon lengthening will present if the rehabilitation method does not provide adequate restriction of movement during the early phases of rehabilitation, as is seen with Achilles tendon ruptures which do not present acutely. Tendon re-rupture will occur if too much load is applied through the tendon before it is healed [24]. Physiotherapists are currently faced with a range of options for managing acute rupture of the Achilles tendon. We know from randomised controlled trials and meta-analysis that immediate weight bearing is safe, and offers functional advantages for this group of patients [5]. The next step is to determine which combination of the individual components of immediate weight bearing rehabilitation will provide optimal outcomes. Future research should be directed towards developing a theoretical basis on which to direct feasibility and piloting within a clinical context. This could be developed through quantifying and evaluating gait parameters to determine how the combinations of the individual components interact within a non-clinical setting. Conclusions, limitations and implications of key findings This review searched a wide range of databases, using a comprehensive search strategy. Articles were translated when required and were reviewed by two independent reviewers. The key limitation is that the articles reported heterogeneous outcome measures, so it was not appropriate to combine the functional outcome data. However, based upon the review of the literature to date, it can be concluded that immediate weight bearing is safe. The type of orthotic that should be worn, the degree of plantarflexion of the ankle and the timing of the removal of the orthotic are all variables which have not been fully evaluated within the literature and require further research. Funding: Arthritis Research UK provided funding for this study as part of an individual fellowship award. They did not have a role in study design, collection, analysis and interpretation of data, writing of the manuscript or in the decision to submit the manuscript for publication. Conflict of interest: None declared. Appendix A. 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