Clinical trial NCT06116799: Managing Pain in Patients With Plantar Fasciitis - A Blinded Randomized Controlled Trial
Official title: Managing Pain in Patients With Plantar Fasciitis - A Blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Plantar Fasciitis
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 19 patients with plantar fasciitis will be allocated to carbon fiber insole group 19 patients with plantar fasciitis will be allocated to polyurethane insole group 19 patients with plantar fasciitis will be allocated to polyethylene insole group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: PROMIS-Pain interference
timeFrame: Baseline, 2nd-, 6th-, and 12th-week follow-ups
measure: PROMIS-Pain intensity
timeFrame: Baseline, 2nd-, 6th-, and 12th-week follow-ups
Secondary outcomes:
measure: Foot and Ankle Outcome Score
timeFrame: Baseline, 2nd-, 6th-, and 12th-week follow-ups
measure: Visual Analogue Scale for pain
timeFrame: Baseline, 2nd-, 6th-, and 12th-week follow-ups
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
citation: 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.
citation: 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
citation: 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
citation: 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
citation: 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.
citation: 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.
citation: 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.