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

NCT01839669 | Terminated

• 1 other identifier: 140928
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Foot Function Index - subcategory pain

  change from baseline (pre intervention) to week 12 (post intervention)

• Foot Function Index - subcategory disability

  change from baseline (pre intervention) to week 12 (post intervention)

• Foot Function Index - subcategory activity limitation

  change from baseline (pre intervention) to week 12 (post intervention)

Other Outcomes (4)

• Pain Disability Index

  change from baseline (pre intervention) to week 12 (post intervention)

• Visual Analogue Scale

  change from baseline (pre intervention) to week 12 (post intervention)

• kinematic data from 3d movement analysis

  change from baseline (pre intervention) to week 12 (post intervention)

Study Arms (3)

Foot Orthoses Only

ACTIVE COMPARATOR

including Patient Education; Abbreviation: FOO

Device: Foot Orthoses Only

Foot Orthoses and Eccentric Exercise

EXPERIMENTAL

including Patient Education; Abbreviation: FOE

Procedure: Foot Orthoses and Eccentric Exercise

Sham Foot Orthoses

SHAM COMPARATOR

including Patient Education; Abbreviation: FOS

Device: Sham Foot Orthoses

Interventions

Foot Orthoses Only DEVICE

patients wear foot orthoses as a treatment condition - no further therapy

Foot Orthoses Only

Foot Orthoses and Eccentric Exercise PROCEDURE

patients wear foot orthoses and they perform an additional home-based eccentric training program for the M. tibialis posterior

Foot Orthoses and Eccentric Exercise

Sham Foot Orthoses DEVICE

patient wear sham foot orthoses (control condition)

Sham Foot Orthoses

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bern University of Applied Sciences: lead
• Swiss National Science Foundation: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (6)

Spital Netz Bern Ziegler

Bern, 3001, Switzerland

Location

Klinik Sonnenhof Bern

Bern, 3006, Switzerland

Location

Inselspital, University Hospital Bern

Bern, 3012, Switzerland

Location

Salem Spital Bern

Bern, 3013, Switzerland

Location

Salem-Spital Orthopädische Klinik Bern

Bern, 3013, Switzerland

Location

spital STS AG

Thun, 3600, Switzerland

Location

Related Publications (6)

• Younger AS, Sawatzky B, Dryden P. Radiographic assessment of adult flatfoot. Foot Ankle Int. 2005 Oct;26(10):820-5. doi: 10.1177/107110070502601006.

  PMID: 16221454 BACKGROUND

• Johnson KA, Strom DE. Tibialis posterior tendon dysfunction. Clin Orthop Relat Res. 1989 Feb;(239):196-206.

  PMID: 2912622 BACKGROUND

• 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.

  PMID: 19022863 BACKGROUND

• 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.

  PMID: 20434675 BACKGROUND

• 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.

  PMID: 20307479 BACKGROUND

• 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.

  PMID: 26279682 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Foot Injuries; Posterior Tibial Tendon Dysfunction; Clubfoot

Interventions

Foot Orthoses

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Foot Diseases; Musculoskeletal Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Heiner Baur, PhD

  Bern University of Applied Sciences, Switzerland

  PRINCIPAL INVESTIGATOR

• Heiner Baur, PhD

  Bern University of Applied Sciences, Health, aR&D Physiotherapy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 25, 2013
• Study Start: July 1, 2013
• Primary Completion: October 25, 2017
• Study Completion: October 25, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

CH (6)