The CurePPaC Study - Analysing Non-surgical Treatment Strategies to Cure Pes Planovalgus Associated Complaints

Pes planovalgus, also called flat foot, is a common foot deformity characterized by a flattening of the foot's longitudinal arch and is accompanied by a dysfunction of the posterior tibial tendon ("posterior tibial tendon dysfunction" or "PTTD"). Early stages of this pathology are thought to be treated with non-surgical therapy options like foot orthoses (relief of tendon stress by mechanical unloading of the arch), strengthening exercises or basic physiotherapeutic measures. Recent literature clearly states the urgent need for high quality studies to evaluate the proposed non-surgical treatments (Bowring 2009, 2010). There is only one high quality study available that shows benefits of orthoses therapy and exercise (Kulig 2009). No study to date evaluated functional changes pre-post in dynamic movement pattern like gait or stair climbing. The widespread use of several non-surgical treatment strategies lead to extensive financial expenses of the health care system. An optimized therapeutic strategy could eventually lead to more efficient health care investments. The presented proposal addresses this latest knowledge and aims to analyse non-surgical treatment strategies to Cure Pes Planovalgus associated Complaints (CurePPaC) in the CurePPaC Study.

Study Overview

• Status: Terminated
• Conditions: Foot Injuries; Posterior Tibial Tendon Dysfunction
• Intervention / Treatment: Device: Foot Orthoses Only; Procedure: Foot Orthoses and Eccentric Exercise; Device: Sham Foot Orthoses

Detailed Description

Introduction: Pes planovalgus or flatfoot-associated complaints are frequent symptoms, which are thought to be caused by the foot deformity itself. Concurrently, the multifactorial weakness of the M. tibialis posterior and its tendon (trauma, systemic disease, chronic tendon degeneration by overuse) can lead to a flattening of the medial longitudinal arch of the foot. Affected patients suffer from functional impairment and pain. Less severe cases are eligible for non-surgical treatment. Foot orthoses are considered to be the first line approach. Furthermore strengthening of the arch and ankle stabilizing muscles are thought to contribute to an active compensation of the deformity. There is only limited evidence concerning the numerous therapy approaches since high quality studies are missing. One excellent report (Kulig et al. 2009) shows clear benefits by the use of foot orthoses and eccentric strengthening exercises. Beside the fact that evidence-based guidelines for therapy have yet to be developed, no data is available showing functional benefits that accompany the therapy process. This would give further insight into mechanisms behind non-surgical management strategies and how patients benefit functionally from therapy. Purpose: The purpose of this randomized longitudinal intervention study is the evaluation of the therapeutic benefit of three different non-surgical treatment regimens (foot orthoses only FOO, foot orthoses and eccentric exercise FOE, foot orthoses sham treatment FOS) in patients with Pes planovalgus and accompanying complaints. Furthermore the analysis of possible functional changes in gait mechanics (kinematic and kinetic view) and neuromuscular control (electromyographic analysis) will contribute to a superior understanding of functional changes that accompany non-operative management. The purpose of the study is to optimize non-surgical management in patients suffering from Pes planovalgus associated pain leading to an efficient use of health care system's financial resources. Methods: 60 patients with Pes planovalgus associated complaints (clinical diagnosis with plain weight bearing radiographs), M. tibialis posterior dysfunction) are included in the study. Functional impairment is evaluated pre and post intervention by the Foot-Function-Index (FFI, German version). Anthropometric data recording is followed by preparation of subject's foot anatomical landmarks with retroreflective markers and superficially detectable muscles of the ankle joint complex are prepared with surface electromyography (SEMG) electrodes. The 3D kinematic data allows inter alia the calculation of segmental angels of the lower extremity and measurement of navicular drop. The neuromuscular activity is analysed in the time (on-off pattern) and amplitude domain (gait cycle specific phases). Procedure: Potential participants are recruited via the Outpatient Clinic of the Department of Orthopaedic Surgery of the Inselspital, University Hospital, Bern. After initial screening, subjects are randomized to one of three intervention groups (foot orthoses only FOO, foot orthoses and eccentric exercise FOE, foot orthoses sham treatment FOS). FOO-subjects wear custom-made foot orthoses only. FOE-subjects wear individually accustomed foot orthoses and they will perform a combined monitored and home training program to progressively strengthen the M. tibialis posterior and accompanying ankle stabilizing muscles with eccentric exercises. FOS-subjects wear custom-made sham foot orthoses without the functional elements of the treatment orthoses (longitudinal arch support, ankle stabilizer, bowl-shaped heel for rearfoot stability). Subjects are measured pre and post intervention (12 weeks). Measurements include the primary outcome measure Foot-Function-Index (FFI, German version: total score) followed by basic anthropometric measures. Subject preparation allows then the measurement of 10 trials on a walkway and on stairs with embedded force plates in barefoot condition. An average step cycle out of 10 trials is calculated and biomechanical outcome measures are extracted. A re-test allows the calculation of intervention effects by one-factor ANOVA (group: treatment FOO vs. FOE vs. FOS) for repeated measures.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3001
    • Spital Netz Bern Ziegler
  • Bern, Switzerland, 3006
    • Klinik Sonnenhof Bern
  • Bern, Switzerland, 3012
    • Inselspital, University Hospital Bern
  • Bern, Switzerland, 3013
    • Salem Spital Bern
  • Bern, Switzerland, 3013
    • Salem-Spital Orthopädische Klinik Bern
  • Thun, Switzerland, 3600
    • Spital STS AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age: 18-60
• Current complaint of foot and ankle pain that lasted for 3 months or more
• Flexible Pes planovalgus deformity in the clinical assessment
• Posterior tibial tendon dysfunction (PTTD) of stage I and II (Johnson & Strom 1989)
• Pes planovalgus foot deformity with longitudinal arch flattening verified by radiograph (Younger 2005): Lateral view: lateral talo-first metatarsal angle ≠ 0° (break of axis): angle >10° according to Younger (2005); 60Anteroposterior view: anteroposterior talo-first metatarsal angle ≠ 0° (break of axis): angle >10° according to Younger (2005)
• "too-many toes"-sign from rear frontal view with an abducted forefoot (Johnson & Strom 1989, Kulig 2009b)
• Eligibility for non-surgical treatment
• No indication / not yet an indication for surgical treatment of foot deformity

Exclusion Criteria:

• Rigid foot deformity
• Posterior tibial tendon dysfunction (PTTD) of stage III and IV according to Johnson & Strom 1989 (=>rigid foot deformity)
• Cardio-, neuro-, or peripheral vascular pathology, musculoskeletal pathology, acute infection or alcohol addiction limiting participation in study protocol
• Acute use of local or systemic analgesics
• Acute physical therapy, training therapy or physiotherapy
• Acute overuse or traumatic injury to the lower leg (excluding Pes planovalgus associated pathology)
• Prior surgery to the lower limb

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Foot Orthoses Only; including Patient Education; Abbreviation: FOO	Device: Foot Orthoses Only; patients wear foot orthoses as a treatment condition - no further therapy
Experimental: Foot Orthoses and Eccentric Exercise; including Patient Education; Abbreviation: FOE	Procedure: Foot Orthoses and Eccentric Exercise; patients wear foot orthoses and they perform an additional home-based eccentric training program for the M. tibialis posterior
Sham Comparator: Sham Foot Orthoses; including Patient Education; Abbreviation: FOS	Device: Sham Foot Orthoses; patient wear sham foot orthoses (control condition)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Function Index - total score	additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8	change from baseline (pre intervention) to week 12 (post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot Function Index - subcategory pain	additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8	change from baseline (pre intervention) to week 12 (post intervention)
Foot Function Index - subcategory disability	additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8	change from baseline (pre intervention) to week 12 (post intervention)
Foot Function Index - subcategory activity limitation	additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8	change from baseline (pre intervention) to week 12 (post intervention)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Disability Index	additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8	change from baseline (pre intervention) to week 12 (post intervention)
Visual Analogue Scale	assessing pain pre- and post biomechanical testing / change from baseline to week 12	change from baseline (pre intervention) to week 12 (post intervention)
kinematic data from 3d movement analysis	regarding distance: navicular drop; regarding angular data (angle at initial contact, max. manifestation during stance, range): foot progression angle, forefoot to rearfoot dorsiflexion, forefoot to rearfoot adduction, forefoot to rearfoot supination, ankle dorsiflexion, ankle adduction, ankle eversion, knee flexion, knee adduction, knee internal rotation, hip flexion, hip adduction, hip internal rotation	change from baseline (pre intervention) to week 12 (post intervention)
neuromuscular activity	EMG of M. tibialis anterior, M. peroneus longus, M. gastrocnemius lateralis/medialis, M. soleus: onset of activation, time of maximum activation, total time of activation, normalized amplitude in preactivation, normalized amplitude in weight acceptance, normalized amplitude in mid-stance, normalized amplitude in push-off	change from baseline (pre intervention) to week 12 (post intervention)

Collaborators and Investigators

• Sponsor: Bern University of Applied Sciences
• Collaborators: University Hospital Inselspital, Berne; Swiss National Science Foundation
• Investigators: Principal Investigator: Heiner Baur, PhD, Bern University of Applied Sciences, Switzerland; Principal Investigator: Heiner Baur, PhD, Bern University of Applied Sciences, Health, aR&D Physiotherapy

Publications and helpful links

General Publications

• Johnson KA, Strom DE. Tibialis posterior tendon dysfunction. Clin Orthop Relat Res. 1989 Feb;(239):196-206.
• Younger AS, Sawatzky B, Dryden P. Radiographic assessment of adult flatfoot. Foot Ankle Int. 2005 Oct;26(10):820-5. doi: 10.1177/107110070502601006.
• Kulig K, Reischl SF, Pomrantz AB, Burnfield JM, Mais-Requejo S, Thordarson DB, Smith RW. Nonsurgical management of posterior tibial tendon dysfunction with orthoses and resistive exercise: a randomized controlled trial. Phys Ther. 2009 Jan;89(1):26-37. doi: 10.2522/ptj.20070242. Epub 2008 Nov 20.
• Bowring B, Chockalingam N. Conservative treatment of tibialis posterior tendon dysfunction--a review. Foot (Edinb). 2010 Mar;20(1):18-26. doi: 10.1016/j.foot.2009.11.001. Epub 2009 Dec 24.
• Bowring B, Chockalingam N. A clinical guideline for the conservative management of tibialis posterior tendon dysfunction. Foot (Edinb). 2009 Dec;19(4):211-7. doi: 10.1016/j.foot.2009.08.001. Epub 2009 Sep 18.
• Blasimann A, Eichelberger P, Brulhart Y, El-Masri I, Fluckiger G, Frauchiger L, Huber M, Weber M, Krause FG, Baur H. Non-surgical treatment of pain associated with posterior tibial tendon dysfunction: study protocol for a randomised clinical trial. J Foot Ankle Res. 2015 Aug 14;8:37. doi: 10.1186/s13047-015-0095-4. eCollection 2015.

Helpful Links

• project description in the database of the Swiss National Science Foundation

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): October 25, 2017
• Study Completion (Actual): October 25, 2017

Study Registration Dates

• First Submitted: April 17, 2013
• First Submitted That Met QC Criteria: April 22, 2013
• First Posted (Estimate): April 25, 2013

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: non-surgical treatment; conservative therapy; Foot-Function-Index; functional movement changes; pes planovalgus; posterior tibial tendon dysfunction
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Congenital Abnormalities; Foot Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot; Foot Injuries; Posterior Tibial Tendon Dysfunction
• Other Study ID Numbers: 140928