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

ABSTRACT: Symptoms 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.After 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.The 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.ClinicalTrials.gov Protocol Registration System: ClinicalTrials.gov ID NCT01839669.

SUBMITTER: Blasimann A

PROVIDER: S-EPMC4536665 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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

Blasimann Angela A Eichelberger Patric P Brülhart Yvonne Y El-Masri Isam I Flückiger Gerhard G Frauchiger Lars L Huber Martin M Weber Martin M Krause Fabian G FG Baur Heiner H

Journal of foot and ankle research 20150814

<h4>Background</h4>Symptoms 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 ...[more]

PMID: 26279682

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Project description:BackgroundPainful conditions such as residual limb pain (RLP) and phantom limb pain (PLP) can manifest after amputation. The mechanisms underlying such postamputation pains are diverse and should be addressed accordingly. Different surgical treatment methods have shown potential for alleviating RLP due to neuroma formation - commonly known as neuroma pain - and to a lesser degree PLP. Two reconstructive surgical interventions, namely targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI), are gaining popularity in postamputation pain treatment with promising results. However, these two methods have not been directly compared in a randomised controlled trial (RCT). Here, we present a study protocol for an international, double-blind, RCT to assess the effectiveness of TMR, RPNI, and a non-reconstructive procedure called neuroma transposition (active control) in alleviating RLP, neuroma pain, and PLP.MethodsOne hundred ten upper and lower limb amputees suffering from RLP will be recruited and assigned randomly to one of the surgical interventions (TMR, RPNI, or neuroma transposition) in an equal allocation ratio. Complete evaluations will be performed during a baseline period prior to the surgical intervention, and follow-ups will be conducted in short term (1, 3, 6, and 12 months post-surgery) and in long term (2 and 4 years post-surgery). After the 12-month follow-up, the study will be unblinded for the evaluator and the participants. If the participant is unsatisfied with the outcome of the treatment at that time, further treatment including one of the other procedures will be discussed in consultation with the clinical investigator at that site.DiscussionA double-blind RCT is necessary for the establishment of evidence-based procedures, hence the motivation for this work. In addition, studies on pain are challenging due to the subjectivity of the experience and the lack of objective evaluation methods. Here, we mitigate this problem by including different pain evaluation methods known to have clinical relevance. We plan to analyse the primary variable, mean change in NRS (0-10) between baseline and the 12-month follow-up, using the intention-to-treat (ITT) approach to minimise bias and keep the advantage of randomisation. The secondary outcomes will be analysed on both ITT and per-protocol (PP). An adherence protocol (PP population) analysis will be used for estimating a more realistic effect of treatment.Trial registrationClincialTrials.gov NCT05009394.

Project description:BackgroundReal time clinical gait analysis (RTCGA) is often incorporated as part of a general or lower limb musculoskeletal (MSK) adult patient assessment. However, it is not known if RTCGA is clinically effective as a useful outcome measure or aids in decision making. Whether there is a clinical worth in conducting RTCGA in adult MSK consultations remains controversial. The aim of this study was to provide unique insights into MSK podiatrists use and opinions of RTCGA, using Posterior Tibial Tendon Dysfunction (PTTD) as an exemplar adult condition.MethodsA qualitative approach was employed to explore MSK podiatrists' views and experiences of RTCGA when assessing or treating patients with PTTD. Semi-structured interviews were conducted via Skype video calls which were transcribed using an orthographic transcription method. Thematic analysis was employed to identify key meanings and report patterns within the data.ResultsTwenty nine MSK podiatrists who used RTCGA in the assessment and treatment of PTTD participated in the study. Five themes were identified as 1) RTCGA Method; 2) Working with RTCGA; 3) RTCGA uses; 4) What could aid RTCGA; 5) How RTCGA skills are acquired. This is the first known study to explore this topic of relevance to clinicians and researchers alike. Clinical observations were not only kinematic, but also included patient perceived experiences such as pain and orthotic comfort with normative kinematic reference values not perceived as important to that management goal. The most common barefoot RTCGA observations performed were the rearfoot to leg angle, medial bulge, forefoot abduction and arch integrity. However, a high amount of variation in many gait observations was noted between participants. Documentation methods also varied with a four-point scale system to grade motion and position most often employed and RTCGA was most often learnt through experience. The main barriers to performing RTCGA were clinical time and space restrictions.ConclusionFindings from this study have provided a view of how podiatry MSK clinicians utilise RTCGA within their practice. MSK podiatrists use RTCGA as both an outcome measure and as an aid in decision making. This implies a perceived worth in conducting RTCGA, however further work is recommended that focusses on development of a national guideline to RTCGA to be adopted.

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

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

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