Managing Pain in Patients With Plantar Fasciitis - A Blinded Randomized Controlled Trial

NCT ID: NCT06116799

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-05-06

Brief Summary

Plantar fasciitis (PF), a leading cause of persistent heel pain, results in almost a million physician visits annually. Conservative treatment is often the first line of management with insoles being frequently prescribed. While multiple studies have compared insoles based on the degree of customization to foot contour, the literature is lacking in data comparing insoles based on their material. In this randomized clinical trial, we compared the early effects of polyethylene (PE), polyurethane (PU), and carbon fiber insoles in the treatment of PF, using a set of patient-reported outcomes.

Detailed Description

Carbon fiber insoles (VKTRY, Milford, CT, USA) were initially designed to increase ground forces leading to a harder push off for faster running or higher jumping. To enable energy return, the insoles require extreme rigidity and therefore are composed of a full-length carbon-fiber base. The highly rigid construct of the carbon fiber can potentially benefit patients with plantar fasciitis by using these insoles in their own shoes, which could lead to more effective pain management, increased compliance, and improved patient outcomes. While this insole is currently being widely used by athletes, the application of this insole for PF patients has not been explored. Therefore, the aim of this study is to understand how patients respond to the these insoles compared to current standard orthotics (Superfeet Green, Superfeet Worldwide LLC. WA, USA and Aetrex L20, Aetrex Inc, NJ, USA) in a blinded randomized controlled trial.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carbon fiber insole

assigned carbon fiber insole

Group Type: EXPERIMENTAL

Orthotic

Intervention Type: DEVICE

Arch support orthotic

Polyurethane

Assigned polyurethane insole

Group Type: ACTIVE_COMPARATOR

Orthotic

Intervention Type: DEVICE

Arch support orthotic

Polyethylene

assigned polyethylene insole

Group Type: ACTIVE_COMPARATOR

Orthotic

Intervention Type: DEVICE

Arch support orthotic

Interventions

Orthotic

Arch support orthotic

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patients (over 18 years old) with plantar fasciitis
• Adults who are competent and able to consent on their own behalf
• Patients who are seen at MGH Boston, MGH Waltham and Newton Wellesley Hospital

Exclusion Criteria

• Patients who received an injection in the last 6 months in their plantar fascia
• Patients who will need to be treated surgically
• Patients who are non-English speaking

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Soheil Ashkani Esfahani

Director, Foot and Ankle Research and Innovation Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

Cohena-Jimenez M, Pabon-Carrasco M, Perez Belloso AJ. Comparison between customised foot orthoses and insole combined with the use of extracorporeal shock wave therapy in plantar fasciitis, medium-term follow-up results: A randomised controlled trial. Clin Rehabil. 2021 May;35(5):740-749. doi: 10.1177/0269215520976619. Epub 2020 Nov 24.

Reference Type: BACKGROUND

PMID: 33233945 (View on PubMed)

Enders, H., Vienneau, J., Tomaras, E. K., Koerger, H., Nigg, S., & Nigg, B. (2015). Soccer shoe bending stiffness significantly alters game-specific physiology in a 25-minute continuous field-based protocol. Footwear Science, 7(sup1), S91-S93. https://doi.org/10.1080/19424280.2015.1038626

Reference Type: BACKGROUND

Bartolo, E., Formosa, C., & Gatt, A. (2017). The Relationship between Plantar Fasciitis and Plantar Heel Pressure. European Journal of Podiatry / Revista Europea de Podología, 3(1), 1-7. https://doi.org/10.17979/ejpod.2017.3.1.1741

Reference Type: BACKGROUND

Bhimani, R., Sornsakrin, P., Vrolyk, M. A., Lubberts, B., Guss, D., DiGiovanni, C. W., & Waryasz, G. R. (2022). Use of Flexible Carbon Fiber Insoles for Hallux Rigidus: A Randomized Controlled Trial. Foot & Ankle Orthopaedics, 7(4), 2473011421S00590. https://doi.org/10.1177/2473011421S00590

Reference Type: BACKGROUND

Gerrard JM, Bonanno DR, Whittaker GA, Landorf KB. Effect of different orthotic materials on plantar pressures: a systematic review. J Foot Ankle Res. 2020 Jun 11;13(1):35. doi: 10.1186/s13047-020-00401-3.

Reference Type: BACKGROUND

PMID: 32527296 (View on PubMed)

Hawke F, Burns J, Radford JA, du Toit V. Custom-made foot orthoses for the treatment of foot pain. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD006801. doi: 10.1002/14651858.CD006801.pub2.

Reference Type: BACKGROUND

PMID: 18646168 (View on PubMed)

Lee SY, McKeon P, Hertel J. Does the use of orthoses improve self-reported pain and function measures in patients with plantar fasciitis? A meta-analysis. Phys Ther Sport. 2009 Feb;10(1):12-8. doi: 10.1016/j.ptsp.2008.09.002. Epub 2008 Nov 20.

Reference Type: BACKGROUND

PMID: 19218074 (View on PubMed)

Other Identifiers

2021P003250

Identifier Type: -

Identifier Source: org_study_id