A clinical guideline for the conservative management of tibialis posterior tendon dysfunction

The Foot 19 (2009) 211–217

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A clinical guideline for the conservative management of tibialis posterior tendon dysfunction Beverly Bowring a,b , Nachiappan Chockalingam b,∗ a b

Cornwall and Isles of Scilly Community Health Services, Penzance, Cornwall, United Kingdom Faculty of Health, Staffordshire University, Leek Road, Stoke on Trent ST4 2DF, United Kingdom

a r t i c l e

i n f o

Article history: Received 22 June 2009 Received in revised form 24 August 2009 Accepted 24 August 2009 Keywords: Tibialis posterior tendon dysfunction (TPTD) Clinical guideline Conservative management Action research

a b s t r a c t Background: Early and appropriate conservative treatment is considered essential to prevent progression of tibialis posterior tendon dysfunction (TPTD), with its potential long term disabling consequences and the need for surgical intervention. However, there is no consensus in the literature regarding the treatment of the disorder. This investigation aimed at developing a local clinical guideline for the conservative management of TPTD by a consensus development group. Methodology: An action research methodology utilising the RAND modified Delphi approach was employed involving seven multidisciplinary consensus group participants. The guideline developed from this process was then sent for national evaluation via postal questionnaire. Results: Although a difference in opinion regarding certain aspects of the conservative management of TPTD was initially present, a local consensus was achieved following extensive discussion. 86% of survey respondents from other localities found the guideline useful but their comments, which were sometimes at odds with each other, revealed a lack of national consensus regarding the management of the condition. Conclusion: This research project has provided empirical evidence that a local clinical guideline can be developed by a consensus group for the management of TPTD. However, the lack of national consensus regarding TPTD treatment found in this research study and as reflected in the published literature, would limit the transferability of this guideline to other localities. While, the guideline reported in this study could be used to inform the development of other national and international guidelines, different areas of expertise that emerged between professions highlighted the importance of employing a multidisciplinary group in the development of guidelines for the management of musculoskeletal conditions of the foot and ankle. © 2009 Elsevier Ltd. All rights reserved.

1. Introduction 1.1. Tibialis posterior tendon dysfunction Tibialis posterior tendon dysfunction (TPTD) has been described as a sudden or progressive loss of strength of the tibialis posterior tendon [1]. It could be due to: acute traumatic injury; inflammatory synovitis secondary to mechanical overuse or systemic disease; and chronic tendon degeneration [2,3]. Numerous aetiological factors have been proposed including traumatic, anatomical, mechanical and ischaemic processes [4–14]. None have surfaced as the sole causative factor, leading most clinicians to suspect a multifactorial aetiology [8]. It is also closely associated with flatfoot deformity, and is considered to be both a cause [10,15] and consequence [6,13] of this deformity.

∗ Corresponding author. Tel.: +44 1782 295853. E-mail address: [email protected] (N. Chockalingam). 0958-2592/$ – see front matter © 2009 Elsevier Ltd. All rights reserved. doi:10.1016/j.foot.2009.08.001

Early and appropriate conservative treatment is considered essential to prevent progression of TPTD, with its potential long term disabling consequences and the need for surgical intervention [16]. Geideman and Johnson [17] referred to the general goals of conservative treatment as: elimination of clinical symptoms; improvement of hindfoot alignment; and the prevention of progressive foot deformity. Various conservative treatment modalities to achieve these goals have been recommended including: antiinflammatory medication; ice therapy; rest; orthotic therapy and footwear; exercise regimes; weight loss; therapeutic ultrasound; and manual therapy techniques [1,7,12,15–37]. However, there is no consensus in the literature regarding the treatment and classification of the disorder [25]. The disability associated with TPTD, the potential to address this via treatment and the present variation in this treatment, are all highlighted by Winning [38] as key reasons for choosing it as a condition for which to develop a clinical treatment guideline. Additionally Woolf et al. [39] have recommended guidelines for the management of musculoskeletal conditions together with the provision of integrated,

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co-ordinated, seamless, multi-professional and multidisciplinary care. 1.2. Clinical guidelines As defined by the Institute of Medicine, clinical guidelines are “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances” [40]. For patients the greatest potential benefit of guidelines are considered to be improved health outcomes, improved consistency of care and the ability to make more informed healthcare choices [41]. They are also considered one way of assisting clinicians in decision making [42] and could bridge the gap between academic research and everyday practice [38]. However, Woolf et al. [41] added that guidelines that might be wrong could result in sub-optimal, ineffective or harmful practices. It is thus considered important that their method of development is rigorous and open to scrutiny. Preparation of quality guidelines should include a systematic review of the literature followed by robust critical appraisal of the evidence about the benefits and harms which is then translated into recommendations in the form of guidelines [43]. Murphy et al. [42] stated that in an ideal world guidelines would be based on evidence derived from rigorously conducted empirical studies. However, a systematic review of the literature undertaken in 2007 (to be published as a separate document), prior to the development of the guideline, revealed limited and poor quality evidence regarding the effects of TPTD conservative treatment modalities. While the detailed description of the methodology and outcome of this systematic review is beyond the scope of this manuscript, it only revealed some uncontrolled studies [24,34–37]. Hence, a cause–effect relationship between interventions and outcomes could not be established. Thus it was necessary to base the guideline fundamentally on expert opinion. It is recommended that a guideline development group is set up to interpret the available evidence, translate it into practice, and derive recommendations in the absence of evidence [43]. Consensus development methods as opposed to individual efforts are recommended by Murphy et al. [42] for producing clinical guidelines, with formal methods, such as the Delphi method and nominal group technique, being considered superior to informal or unstructured approaches. This led to the realisation of the aim of this study as outlined below. 1.3. Aim of study The purpose of this research project was to develop a local clinical guideline for the conservative management of TPTD by means of a consensus development group. This could then be used to inform the development of a national guideline. It was proposed that the guideline would focus on the management of tibialis posterior tendinopathy co-existing with a flexible flatfoot (stage II Johnson and Strom [44] classification system). It excluded children and diabetics as well as TPTD associated with a systemic inflammatory condition, an acute traumatic rupture/injury, a completely rigid flatfoot, and ankle joint degeneration. 2. Methodology 2.1. Action research An action research approach was employed as it was the most suitable methodology to address this aim. Unlike the positive and interpretive paradigms, action research is considered not merely to understand situations and phenomena, but also to change them. It is considered a powerful tool for change and improvement at

local level [45]. Participants are not treated as passive subjects but empowered to act on their own behalf as active participants in making changes [46], also apt for this project. This form of research is characterised by a spiral process which involves successive circles of planning, acting, observing and reflecting [45,47]. In later cycles, continuous refining of methods, data and interpretation in the light of understanding developed in earlier cycles would occur [48]. Clarity and rigour are thus considered to be enhanced with each research cycle [47,49]. A smaller earlier project, to develop a similar guideline for TPTD, could be considered a first cycle of action research upon which this larger research project was based. 2.2. RAND modified Delphi approach Murphy et al. [42] found no optimum method for reaching consensus in the development of clinical guidelines. However, they did recommend desirable attributes to be employed which were fulfilled by the RAND modified Delphi approach as described by Buetow and Coster [50]. These authors reported that it offered a systematic and rigorous method for combining limited evidence with expert opinion and had been shown to be reliable and valid. It is considered the most commonly used method for guideline production [42]. The method employed in this project was thus based on this approach which was also successfully employed in the first cycle of action research. The method involved: the development of a preliminary guideline by the researcher following a systematic review of the literature; a postal rating of its 59 statements, employing 1–9 Likert scales (to comply with the RAND modified Delphi approach), by consensus group participants; an audiotaped consensus group meeting in which discussion between consensus participants regarding controversial issues resulted in an amended guideline; an individual rating of the amended guideline statements. This culminated in the development of the final guideline (Cornwall Guideline). For statements to be included in the final guideline, their group rating scores needed to be in the three point range 7–9 and they needed to have a median group rating score of 8 or 9. These latter strict criteria are considered to enhance the reproducibility of the ratings [51]. The final guideline was sent for national evaluation to potential users via a postal questionnaire. Shekelle et al. [43] suggested that guidelines should receive external review to ensure content validity, clarity and applicability and that potential users of the guidelines could judge their usefulness. An evaluation stage is also considered an important element of action research [52]. The study was conducted from October 2007 to February 2008. 2.3. The participants 2.3.1. Consensus group participants The consensus group were comprised of seven healthcare professionals of different disciplines who were purposefully sampled: a consultant orthopaedic surgeon; a consultant radiologist; an orthotist; two musculoskeletal specialist podiatrists; and two senior physiotherapists. This formed a representative group in a typical local Health service setup. A facilitator was also recruited to enhance consensus development as recommended by Murphy et al. [42]. 2.3.2. Survey participants The initial survey participants were 30 experienced podiatrists, randomly selected by number tables, from a university based professional network list. As a sampling frame of other healthcare professionals also experienced in the treatment of TPTD was not known, snowball sampling occurred to recruit the other 120 survey participants. The snowballing technique involves the researcher

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Table 1 Rating scores for two statements indicated high and low levels of agreement. The footwear should work synergistically with the orthotic device to fulfill the orthotic aims Rating score 1 2 3 4 5 Frequency 0 0 0 0 0

6 0

7 0

8 1

9 5

Median 9

Employ the Foot Posture Index as an outcome measure to evaluate triplanar flatfoot deformity Rating score 1 2 3 4 5 Frequency 1 0 0 1 1

6 1

7 0

8 0

9 1

Median 5

asking an initial group to recruit others they know are in the target group. In this case the 30 participants were asked to distribute copies of the final guideline and questionnaire to each member of the multidisciplinary team in their area involved in the management of TPTD. Any participant in the consensus group was excluded as a survey participant. 2.4. Ethical approval Ethical approval was granted by Cornwall and Plymouth Research Ethics Committee in February 2007. 3. Results Fig. 1. Professions of the respondents.

3.1. Consensus group activities The initial postal rating scores for statements on the preliminary guideline, by consensus group participants, indicated that there were areas where a high level of agreement already existed as well as controversial areas that needed to be resolved before consensus could be achieved. This is illustrated by the postal ratings of two preliminary guideline statements in Table 1. Four participants did not rate some statements whose subjects fell outside of their areas of expertise. During the consensus meeting, some statements were accepted with no or minimal discussion, whilst other controversial statements provoked more extensive discussions which resulted in statements being either accepted without change, amended or rejected altogether. Occasionally statements were added. An amended guideline thus emerged from this process. Controversial areas, in the order that they were discussed, are summarised in Table 2. The rating scores for statements on the amended guideline, with all but two statements receiving scores in the range of 7–9 and a group median score of 8 and above, indicated a high level of agreement of participants with the guideline statements and with each other. The two statements that did not achieve this high level of agreement were rejected and as such the final guideline emerged.

3.2. Survey 37 of the 150 questionnaires were returned giving a response rate of 25%. One was discarded due to incomplete data, thus 36 returned questionnaires were analysed. The professions of the respondents are shown in Fig. 1. 31 (86%) respondents found the guideline useful. How useful respondents found the guideline is shown in the frequencies of the rating scores in Fig. 2 below, where 1 is not useful at all and 9 extremely useful. The median rating score was 6, and the mode was 7. Both positive and negative comments were recorded as reasons that influenced respondents rating scores regarding the usefulness of the guideline. 29 (81%) of respondents recorded positive reasons that influenced their ratings and 34 (94%) of respondents recorded negative reasons as shown in Table 3. 33 (92%) or respondents suggested minor and major improvements to the guideline, which could be classified into five broad categories: improve format/presentation; change recommendation; expand section; add section; provide extra educational information.

Table 2 Controversial areas discussed during the consensus group meeting. FPI = Foot Posture Index. FFI = Foot Function Index. Insidious onset and overuse as significant diagnostic factors Tibialis posterior strength testing Single stance heel raise test Overall purpose of TPTD management The inability of some providers of conservative care to prescribe medication The need to restrict ankle joint dorsiflexion on a removable boot The need to provide “Pin cam walker” as an example of a removable boot Patient compliance with advised treatments, especially footwear advise The need for semi-bespoke or bespoke footwear for stage II TPTD The concepts of improving core stability and improving lumbar–pelvic posture The inclusion of ultrasound on the guideline The suitability of transverse friction massage for a failing tendon The FPI and FFI as appropriate outcome measures for TPTD The need to refer to “resources” in the guideline The frequency of guideline review

Fig. 2. Rating scores of usefulness.

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Table 3 Positive and negative reasons regarding guideline usefulness, in terms of its function and its format and content to perform that function. Positive reasons regarding usefulness

Negative reasons regarding usefulness

Function Educational aid for inexperienced clinicians Consistent with/reinforces respondent’s own management plan Reminder/reference tool Provides a logical rationale for treatment Provides written evidence for patient/third parties Indicator of referral and care pathways to aid triage

Function Has no educational value for experienced practitioners Similar resources already available

Format and content Thorough/comprehensive

Format and content Insufficient detail/missing treatments in current sections/missing sections Poor format/presentation Too wordy/inconcise Contentious statements Unclear/difficult to follow Insufficiently flexible/insufficiently prescriptive

Well structured Concise/succinct/focused Accurate Clear/easy to follow Flexible/not too prescriptive

4. Discussion 4.1. Consensus group activities Although a difference of opinion regarding the management of TPTD was initially present, this research project has provided empirical evidence that a local clinical guideline can be developed by a consensus group for the management of TPTD. In order to achieve this consensus, extensive discussion on the management of various controversial areas were necessary and compromises sometimes had to be made. The high level of agreement of consensus participants with the final local guideline statements and with each other was illustrated by the rating scores for statements on the amended guideline, with 54 of the 56 statements receiving scores in the range of 7–9 and a group median score of 8 and above. Particular controversial areas, taking up 12% of the total discussion time, focused on the suitability of the Foot Posture Index [53] and Foot Function Index [54] as outcome measures in the management of TPTD. One participant had presumed that the Foot Posture Index was just employed to measure an improvement in foot posture that he/she did not feel would be a good indicator of the success of treatment as, “You can certainly change the forces within the foot without having a massive change in foot position”. On clarifying that it was also being employed to measure progression of flatfoot deformity, itself an important surgical indicator, the participant agreed that it should be included as an outcome measure. The choice of the Foot Function Index over other subjective patient measures was also discussed. It was acknowledged that this foot-specific outcome measure was not ideal, as it had been validated on patients with rheumatoid arthritis [54], but a more suitable validated subjective outcome measure could not be suggested. This revealed a potential area for further research, also highlighted by a survey respondent, which is the development of a subjective outcome measure specifically for TPTD. Another controversial area that provoked 11% of the total discussion time was the need to add to the guideline the “single stance heel raise test”, described by Meehan and Brage [2], as a diagnostic indicator for TPTD. It had not been included as the sensitivity and specificity of this test was questionable. Yeap et al. [13] found that on a follow up study of patients who had received a tibialis

posterior tendon transfer for peroneal palsy, 82% could still perform a single stance heel raise. Inability to perform this test has been attributed to loss of osteoligamentous restraints across the midfoot as can occur in more advanced flatfoot deformity [10] and forefoot pain [55]. It could also be argued that a functional hallux limitus, a structural hallux limitus or rigidus, a weak Achilles tendon or ankle arthritis could also be other reasons for failure of this test. However, one participant stated that he/she always included the single stance heel raise “. . .in my package of examination. . .” in the diagnosis of TPTD, which was reiterated by other participants. The phraseology of the final statement that emerged from the discussion, “TPTD is unlikely if the patient is capable of performing repeated normal single stance heel raises without pain. . .” was designed to address the potential lack of sensitivity and specificity of the test. Non-controversial issues also arose during the consensus group meeting including the educational function of the guideline. Examples were retained to illustrate some statements, as they provided educational value for those guideline users, or referrers for conservative treatment, who might not be familiar with all the possible treatment options that could be employed in these areas. This might subsequently prompt them to refer onto those disciplines who could provide a particular conservative treatment if they could not provide it themselves. In this way appropriate and timely interdisciplinary care would be promoted, enhancing referral and care pathways, and reducing premature referral for a surgical opinion. This would be expected to reduce surgical waiting times as well have financial implications, the expense of surgical foot and ankle clinics having also been highlighted in the consensus group discussion. This point was reiterated by a survey respondent. “Useful to clarify and indicate appropriate proposed pathways in treating TPTD in trust setting. Especially for financial reasons if referrers understand and acknowledge TPTD can be assessed by specialist podiatrist in primary care as apposed to going straight into secondary care-triage” The different areas of expertise between healthcare professionals who delivered conservative care for TPTD prompted one participant to raise, “. . .the need for multidisciplinary team work within the treatment of these sorts of conditions”. This point was illustrated by the consensus group activities which revealed locally, different areas of expertise of each profession across the various domains of the “treatment options” and other sections. These different areas of expertise would uphold the decision to employ a multidisciplinary consensus group to develop this guideline. Murphy et al. [42], in their review of the literature, found that different healthcare professionals studying the same issues produced different judgements. More specifically, members of a speciality were more likely to advocate techniques that involve their specialty. This may have reflected their greater knowledge of the scientific evidence on the appropriate use of the technique or their limited perspective on alternative strategies. 4.2. Survey The survey sought to investigate respondents’ opinions on the usefulness of the guideline and whether any improvements could be made. Although 86% respondents found the guideline useful, perceptions of how useful it was varied as illustrated by Fig. 2. Positive comments expressed on the usefulness of the guideline by some respondents were at odds with the negative comments expressed by others (Table 3), as were suggested improvements. For example some respondents suggested more detail and less flexibility while others suggested the opposite. The difficulty of achieving a balance between detail and flexibility has also been highlighted in the literature. Guidelines that are inflexible can harm

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by leaving insufficient room for clinicians to tailor care to patient’s personal circumstances and medical history [41]. However, on the other hand they can be criticized if they are too general and bland [56] and thus provide insufficient guidance. The provision of detail had to be sometimes decreased in order that consensus could be reached by members of the consensus group as occurred with tibialis posterior strength testing, removal boot detail and the recommendation to limit ankle joint dorsiflexion. Interestingly suggested improvements by some survey respondents included more detail on these issues. A suggested improvement by two respondents was to arrange treatment according to the specific tendon pathology present, a practice demonstrated by Wainwright et al. [57]. However, other respondents concurred with the guideline recommendation to trial conservative care initially for all patients, as advocated by Sitler and Bell [58], and use clinical indicators of pain, function, and flatfoot deformity to direct management rather than specific tendon pathology. Differences in opinion on the timing of the introduction of strengthening exercises for tibialis posterior was also found to differ between respondents. One respondent considered that these exercises should not be introduced immediately and the final guideline suggested introducing them when painful symptoms had subsided. However, another respondent considered that, “High tendon loading is recommended as first line and moderate discomfort is expected initially”. It has been demonstrated that painful eccentric exercises in patients with mid-portion chronic Achilles tendinosis has good short-term [59,60] and mid-term results [61]. However, Davenport et al. [62] suggested that additional studies were needed to document possible adverse effects of eccentric loading programmes. In their study, published after the development of this guideline, Kulig et al. [63] reported no adverse effects in patients with symptomatic TPTD, when undertaking painless concentric and eccentric resistive foot adduction exercises. They found that these exercises, combined with the wear of foot orthoses and performing calf stretches, reduced pain and improved function. The study by Kulig et al. [63] would suggest that patients with painful TPTD could undertake tibialis posterior strengthening exercises whilst still symptomatic, although no pain should be experienced during the actual performance of the exercises. Two respondents considered that a decrease in orthotic control if patient progress allowed, as recommended in the guideline, would not be achievable. One respondent elaborated on his/her reasons as illustrated in the quotation below.

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an orthotic device might be needed, in keeping with the views of the above respondent. However, in stage I and II TPTD, Alvarez et al. [34] found that strengthening tibialis posterior and other peri-ankle muscles increased their strength and function as well as reduced the orthotic control required, 73% of patients with ankle–foot converting to foot orthoses. It could be however, that in these cases ligamentous competence was present or a reduction in pain enabled less orthotic control. It is also possible that foot posture and function might be improved by intrinsic means, other than improving the strength of tibialis posterior, which could impact on the ability to modify the orthotic prescription. For example by such intrinsic means as losing weight, stretching a short gastrocnemius muscle, which could be resulting in a pronatory force at heel lift, and by improving core stability and lumbar–pelvic posture. The results of the survey indicated that there was no national consensus regarding the conservative treatment of TPTD, a phenomenon also noted in the literature [25]. This would highlight the need to seek an agreement between clinicians who would be involved in treating the condition at a local level, as suggested by Williams [65] and would limit the generalisability of this local guideline, in its present form, to other localities. However, this guideline could be used to inform the development of other guidelines. 4.3. Limitations of the study There were three main limitations to the study. A criticism of the RAND method is the non-involvement of patients [66] which have been recommended in guideline development [67] and could result in different decisions being made [42]. Researcher bias could have been another limitation with the researcher shaping the content

“Restoring strength and function of tibialis posterior tendon is something that I’ve never seen in all my years of practice. Patient compliance is an issue, but by the time the patient presents with a flexible flatfoot, its probably too late to halt the progression, let alone return the foot to a more normal functional state. This then undermines your statement to modify the patient’s orthotic prescription according to the patients response to treatment.” A broad range of pathologies in stage II TPTD have been highlighted, including different degrees of rearfoot ligamentous integrity and varying flexibilities of flatfoot deformity [10]. Cadaveric studies, mimicking late stage II TPTD, a flatfoot deformity with compromised ligamentous integrity, have found that contraction of the tibialis posterior tendon could not prevent forces in the foot from shifting medially, could not lock the bones of the rearfoot and arch at heel rise [6] and minimally improved rearfoot kinematics [64]. This would suggest that in an advanced flatfoot deformity, with ligamentous incompetence, tibialis posterior tendon strengthening exercises alone would be insufficient to address the flatfoot deformity and continued extrinsic support to the foot in terms of

Fig. 3. Areas for future research employing further cycles of action research (as depicted by broken circles) and other research methodologies. CG = clinical guideline, CGP = consensus group participants, RCT = randomised controlled trials.

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and format of the preliminary guideline. Finally the low response rate (25%) of the postal survey could have meant that the possible range of comments on the guideline usefulness and suggested improvements were not exhausted, particularly in other professions to podiatry which made up only 14% of respondents. 4.4. Areas for further research This research project has revealed many possible areas for future research, employing further spirals of action research and other methodologies depending on their different aims, as illustrated in Fig. 3. 5. Conclusion Although a difference of local opinion regarding the management of TPTD was initially present, this research project has provided empirical evidence that a local clinical guideline can be developed by a consensus group for the management of TPTD. The different areas of expertise between professions that emerged during the course of the study would highlight the importance of employing a multidisciplinary group in the development of guidelines for the management of musculoskeletal conditions of the foot and ankle. 86% of survey respondents, who evaluated the guideline, found it useful. However, suggested improvements by respondents revealed a lack of national consensus regarding the management of TPTD, as reflected in the literature [25], and would limit the transferability of this guideline, in its present form, to other localities. However, this guideline could be used to inform the development of other national and international guidelines. Potential benefits of guidelines were highlighted by consensus group participants and survey respondents including: providing educational value for guideline users and referrers; promoting timely and appropriate patient treatment; reducing surgical referrals; acting as a reminder or reference tool, providing a rationale for treatment; and providing written evidence for patients and third parties. Another potential benefit has been highlighted by Winning [38] as bridging the research-practice gap, a potential attribute of action research itself [68]. Conflict of interest The authors have no commercial conflict of interest(s) in this work. Appendix A. Supplementary data Supplementary data associated with this article can be found, in the online version, at doi:10.1016/j.foot.2009.08.001. References [1] Mendicino SS. Posterior tibial tendon dysfunction. Clin Podiatr Med Surg 2000;17(1):33–53. [2] Meehan RE, Brage M. Adult acquired flatfoot deformity: clinical and radiological examination. Foot Ankle Clin North Am 2003;8:431–52. [3] Bare AA, Haddad SL. Tenosynovitis of the posterior tibial tendon. Foot Ankle Clin 2001;6(1):37–66. [4] Frey C, Shereff M, Greenidge N. Vascularity of the posterior tibial tendon. J Bone Joint Surg Am 1990;72-A:884–8. [5] Holmes GB, Mann RA. Possible epidemiological factors associated with rupture of the posterior tibial tendon. Foot Ankle 1992;13:70–9. [6] Imhauser CW, Siegler S, Abidi NA, Frankel NA, Frankel DZ. The effect of posterior tibialis tendon dysfunction on the plantar pressure characteristics and the kinematics of the arch and the hindfoot. Clin Biomech 2004;19:161–9. [7] Katchis SD. Posterior tibial tendon dysfunction. In: Ranawat CS, Positano RG, editors. Disorders of the heel, rearfoot and ankle. London: Churchill Livingstone; 1999. p. 415–22.

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