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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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 healt
Sponsor: Bern University of Applied Sciences

Current Primary Outcome: Foot Function Index - total score [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Foot Function Index - subcategory pain [ Time Frame: change from baseline (pre intervention) to week 12 (post intervention) ]
  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) ]
  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) ]
  additional analysis of change from baseline to week 4, and analysis of change from baseline to week 8

Original Secondary Outcome: Same as current

Information By: Bern University of Applied Sciences

Dates:
Date Received: April 17, 2013
Date Started: July 2013
Date Completion: December 2017
Last Updated: March 8, 2016
Last Verified: March 2016