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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Bern University of Applied Sciences
Sponsor:
Collaborators:
Swiss National Science Foundation
University Hospital Inselspital, Berne
Information provided by (Responsible Party):
Heiner Baur (PhD), Bern University of Applied Sciences
ClinicalTrials.gov Identifier:
NCT01839669
First received: April 17, 2013
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Foot Injuries
Posterior Tibial Tendon Dysfunction
Device: Foot Orthoses Only
Procedure: Foot Orthoses and Eccentric Exercise
Device: Sham Foot Orthoses

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The CurePPaC Study - Analysing Non-surgical Treatment Strategies to Cure Pes Planovalgus Associated Complaints

Resource links provided by NLM:


Further study details as provided by Bern University of Applied Sciences:

Primary Outcome Measures:
  • Foot Function Index - total score [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ] [ Designated as safety issue: No ]
    additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8


Secondary Outcome Measures:
  • Foot Function Index - subcategory pain [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ] [ Designated as safety issue: No ]
    additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8

  • Foot Function Index - subcategory disability [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ] [ Designated as safety issue: No ]
    additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8

  • Foot Function Index - subcategory activity limitation [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ] [ Designated as safety issue: No ]
    additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8


Other Outcome Measures:
  • Pain Disability Index [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ] [ Designated as safety issue: No ]
    additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8

  • Visual Analogue Scale [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ] [ Designated as safety issue: No ]
    assessing pain pre- and post biomechanical testing / change from baseline to week 12

  • kinematic data from 3d movement analysis [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ] [ Designated as safety issue: No ]
    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

  • neuromuscular activity [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: July 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839669

Contacts
Contact: Heiner Baur, PhD +41 31 848 45 15 heiner.baur@bfh.ch

Locations
Switzerland
Inselspital, University Hospital Bern Recruiting
Bern, Switzerland, 3012
Contact: Fabian Krause, PD, Phd    +41-31 632 22 20    FabianGoetz.Krause@insel.ch   
Principal Investigator: Fabian Krause, PD, MD         
Spital Netz Bern Ziegler Recruiting
Bern, Switzerland, 3001
Contact: Martin Weber, PD, PhD    +41 31 970 73 47    Martin.Weber@spitalnetzbern.ch   
Principal Investigator: Martin Weber, PD, MD         
Salem Spital Bern Recruiting
Bern, Switzerland, 3013
Contact: Isam El-Masri, PhD    +41 31 337 66 96    isam.elmasri@hirslanden.ch   
Principal Investigator: Isam El-Masri, MD         
Klinik Sonnenhof Bern Recruiting
Bern, Switzerland, 3006
Contact: Gerhard Flückiger, MD    +41 31 358 12 61    gerhardflueckiger@sonnenhof.ch   
Principal Investigator: Gerhard Flückiger, MD         
Salem-Spital Orthopädische Klinik Bern Recruiting
Bern, Switzerland, 3013
Contact: Martin Huber, MD    +41 31 333 82 30    martinhuber58@hotmail.com   
Principal Investigator: Martin Huber, MD         
spital STS AG Recruiting
Thun, Switzerland, 3600
Contact: Lars Frauchiger, MD    +41 33 226 21 61    lars.frauchiger@spitalstsag.ch   
Principal Investigator: Lars Frauchiger, MD         
Sponsors and Collaborators
Bern University of Applied Sciences
Swiss National Science Foundation
University Hospital Inselspital, Berne
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
  More Information

Additional Information:
Publications:
Responsible Party: Heiner Baur (PhD), PhD, Bern University of Applied Sciences
ClinicalTrials.gov Identifier: NCT01839669     History of Changes
Other Study ID Numbers: 140928
Study First Received: April 17, 2013
Last Updated: March 31, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Bern University of Applied Sciences:
conservative therapy
Foot-Function-Index
functional movement changes
non-surgical treatment
pes planovalgus
posterior tibial tendon dysfunction

Additional relevant MeSH terms:
Flatfoot
Foot Injuries
Posterior Tibial Tendon Dysfunction
Wounds and Injuries
Foot Deformities
Musculoskeletal Diseases
Leg Injuries
Foot Diseases

ClinicalTrials.gov processed this record on August 25, 2014