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

Blasimann A, Eichelberger P, Brülhart Y, El-Masri I, Flückiger G, Frauchiger L, Huber M, Weber M, Krause FG, Baur H - J Foot Ankle Res (2015)

Bottom Line: 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).Measuring outcomes pre- and post-intervention will allow the calculation of intervention effects by 3×3 Analysis of Variance (ANOVA) with repeated measures.

View Article: PubMed Central - PubMed

Affiliation: Bern University of Applied Sciences, Health, Physiotherapy, Murtenstrasse 10, 3008 Bern, Switzerland.

ABSTRACT

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov Protocol Registration System: ClinicalTrials.gov ID NCT01839669.

No MeSH data available.


Related in: MedlinePlus

Study flow chart: randomisation of patients to one of three intervention groups: foot orthoses only FOO, foot orthoses and eccentric exercise FOE, sham foot orthoses only FOS
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Fig1: Study flow chart: randomisation of patients to one of three intervention groups: foot orthoses only FOO, foot orthoses and eccentric exercise FOE, sham foot orthoses only FOS

Mentions: The study design is a parallel-group randomised trial with three intervention groups receiving therapy regimens aimed at symptoms associated with pes planovalgus (Fig. 1). There will be an intervention phase of 12 weeks, which is a common therapy window for the associated symptoms of clinical problems like pes planovalgus [38]. Participants’ pain and functional impairment perception will be measured pre- and post-intervention (and in the middle of the intervention period). Biomechanical measurements (standardised laboratory study) before and after the intervention phase will accompany the protocol to evaluate possible functional changes induced by the therapy regimen.Fig. 1


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

Blasimann A, Eichelberger P, Brülhart Y, El-Masri I, Flückiger G, Frauchiger L, Huber M, Weber M, Krause FG, Baur H - J Foot Ankle Res (2015)

Study flow chart: randomisation of patients to one of three intervention groups: foot orthoses only FOO, foot orthoses and eccentric exercise FOE, sham foot orthoses only FOS
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4536665&req=5

Fig1: Study flow chart: randomisation of patients to one of three intervention groups: foot orthoses only FOO, foot orthoses and eccentric exercise FOE, sham foot orthoses only FOS
Mentions: The study design is a parallel-group randomised trial with three intervention groups receiving therapy regimens aimed at symptoms associated with pes planovalgus (Fig. 1). There will be an intervention phase of 12 weeks, which is a common therapy window for the associated symptoms of clinical problems like pes planovalgus [38]. Participants’ pain and functional impairment perception will be measured pre- and post-intervention (and in the middle of the intervention period). Biomechanical measurements (standardised laboratory study) before and after the intervention phase will accompany the protocol to evaluate possible functional changes induced by the therapy regimen.Fig. 1

Bottom Line: 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).Measuring outcomes pre- and post-intervention will allow the calculation of intervention effects by 3×3 Analysis of Variance (ANOVA) with repeated measures.

View Article: PubMed Central - PubMed

Affiliation: Bern University of Applied Sciences, Health, Physiotherapy, Murtenstrasse 10, 3008 Bern, Switzerland.

ABSTRACT

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov Protocol Registration System: ClinicalTrials.gov ID NCT01839669.

No MeSH data available.


Related in: MedlinePlus