Clinical trial NCT01839669: The CurePPaC Study - Analysing Non-surgical Treatment Strategies to Cure Pes Planovalgus Associated Complaints
Official title: The CurePPaC Study - Analysing Non-surgical Treatment Strategies to Cure Pes Planovalgus Associated Complaints
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Foot Injuries
Posterior Tibial Tendon Dysfunction
Keywords: conservative therapy
Foot-Function-Index
functional movement changes
non-surgical treatment
pes planovalgus
posterior tibial tendon dysfunction
Lead sponsor: Bern University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Insel Gruppe AG, University Hospital Bern
First posted: 2013-04-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Foot Function Index - total score
timeFrame: change from baseline (pre intervention) to week 12 (post intervention)
Secondary outcomes:
measure: Foot Function Index - subcategory pain
timeFrame: change from baseline (pre intervention) to week 12 (post intervention)
measure: Foot Function Index - subcategory disability
timeFrame: change from baseline (pre intervention) to week 12 (post intervention)
measure: Foot Function Index - subcategory activity limitation
timeFrame: change from baseline (pre intervention) to week 12 (post intervention)
Other outcomes:
measure: Pain Disability Index
timeFrame: change from baseline (pre intervention) to week 12 (post intervention)
measure: Visual Analogue Scale
timeFrame: change from baseline (pre intervention) to week 12 (post intervention)
measure: kinematic data from 3d movement analysis
timeFrame: change from baseline (pre intervention) to week 12 (post intervention)
measure: neuromuscular activity
timeFrame: change from baseline (pre intervention) to week 12 (post intervention)
Locations:
city: Bern
country: Switzerland
facility: Spital Netz Bern Ziegler
city: Bern
country: Switzerland
facility: Klinik Sonnenhof Bern
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Bern
city: Bern
country: Switzerland
facility: Salem Spital Bern
city: Bern
country: Switzerland
facility: Salem-Spital Orthopädische Klinik Bern
city: Thun
country: Switzerland
facility: spital STS AG
Study officials:
affiliation: Bern University of Applied Sciences, Switzerland
name: Heiner Baur, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bern University of Applied Sciences, Health, aR&D Physiotherapy
name: Heiner Baur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Younger AS, Sawatzky B, Dryden P. Radiographic assessment of adult flatfoot. Foot Ankle Int. 2005 Oct;26(10):820-5. doi: 10.1177/107110070502601006.
citation: Johnson KA, Strom DE. Tibialis posterior tendon dysfunction. Clin Orthop Relat Res. 1989 Feb;(239):196-206.
citation: 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.
citation: 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.
citation: 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.
citation: 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.