Non‐surgical treatment of pain associated with posterior tibial tendon dysfunction: study protocol for a randomised clinical trial

Abstract

BackgroundSymptoms associated with pes planovalgus or flatfeet occur frequently, even though some people with a flatfoot deformity remain asymptomatic. Pes planovalgus is proposed to be associated with foot/ankle pain and poor function. Concurrently, the multifactorial weakness of the tibialis posterior muscle and its tendon can lead to a flattening of the longitudinal arch of the foot. Those affected can experience functional impairment and pain. Less severe cases at an early stage are eligible for non-surgical treatment and foot orthoses are considered to be the first line approach. Furthermore, strengthening of arch and ankle stabilising muscles are thought to contribute to active compensation of the deformity leading to stress relief of soft tissue structures. There is only limited evidence concerning the numerous therapy approaches, and so far, no data are available showing functional benefits that accompany these interventions.MethodsAfter clinical diagnosis and clarification of inclusion criteria (e.g., age 40–70, current complaint of foot and ankle pain more than three months, posterior tibial tendon dysfunction stage I & II, longitudinal arch flattening verified by radiography), sixty participants with posterior tibial tendon dysfunction associated complaints will be included in the study and will be randomly assigned to one of three different intervention groups: (i) foot orthoses only (FOO), (ii) foot orthoses and eccentric exercise (FOE), or (iii) sham foot orthoses only (FOS). Participants in the FOO and FOE groups will be allocated individualised foot orthoses, the latter combined with eccentric exercise for ankle stabilisation and strengthening of the tibialis posterior muscle. Participants in the FOS group will be allocated sham foot orthoses only. During the intervention period of 12 weeks, all participants will be encouraged to follow an educational program for dosed foot load management (e.g., to stop activity if they experience increasing pain). Functional impairment will be evaluated pre- and post-intervention by the Foot Function Index. Further outcome measures include the Pain Disability Index, Visual Analogue Scale for pain, SF-12, kinematic data from 3D-movement analysis and neuromuscular activity during level and downstairs walking. Measuring outcomes pre- and post-intervention will allow the calculation of intervention effects by 3×3 Analysis of Variance (ANOVA) with repeated measures.DiscussionThe purpose of this randomised trial is to evaluate the therapeutic benefit of three different non-surgical treatment regimens in participants with posterior tibial tendon dysfunction and accompanying pes planovalgus. Furthermore, the analysis of changes in gait mechanics and neuromuscular control will contribute to an enhanced understanding of functional changes and eventually optimise conservative management strategies for these patients.Trial registrationClinicalTrials.gov Protocol Registration System: ClinicalTrials.gov ID NCT01839669

Role of Tendoscopy in Treating Stage II Posterior Tibial Tendon Dysfunction

“…5,28 In the current literature, there is an ongoing controversy regarding the best therapeutic approach for this stage. Initial treatment is usually conservative, consisting of foot orthoses 6 in conjunction with calf muscle stretching 23 and strengthening exercises 4 and occasionally local anesthetic with corticosteroid injection. Although good results have been demonstrated at up to 7 to 10 years' follow-up with insoles, 34 their external mechanical action often proves insufficient, or they may be poorly tolerated because of swelling and pain.…”

Effect of 3D Printing Individualized Ankle-Foot Orthosis on Plantar Biomechanics and Pain in Patients with Plantar Fasciitis: A Randomized Controlled Trial

“…After 2 minutes of acclimatization of standing and walking, the participants completed 3 walks along each 10-m walkway under each condition, and each test involved a stopwatch to control walking speed. If the trial was not within 5% of the original walking time, the trial was repeated to minimize the effect of walking speed on plantar pressure [27]. The average walking speed of all trials was 3.5 km/hour (±3.0 km/hour).…”

Assessment of foot function in patients with pes planus deformity treated with the authors’ own exercise programme – a preliminary report

“…Do oceny wyników mają być wykorzystane: ankieta Foot Function Index (FFI), Pain Disability Index (PDI), wizualno-analogowa skala do oceny bólu (VAS) oraz badanie biomechaniczne z użyciem platform w staniu, chodzie po płaskiej powierzchni i podczas schodzenia po schodach. Zaplanowane badania być może pozwolą poszerzyć aktualną wiedzę dotyczącą skuteczności i możliwo-ści leczenia zachowawczego w niewydolności ścię-gna mięśnia piszczelowego tylnego [18].…”

“…The Foot Function Index (FFI), the Pain Disability Index (PDI), Visual Analogue Scale for pain (VAS) and a biomechanical examination with the use of force plates during standing as well as level and downstairs walking will be applied to assess the results. The planned study may contribute to enriching current knowledge regarding effectiveness and possibilities of conservative treatment of posterior tibial tendon dysfunction [18].…”