Managing Pain in Patients With Plantar Fasciitis - A Blinded Randomized Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Carbon fiber insole assigned carbon fiber insole |
Device: Orthotic
Arch support orthotic
|
| Active Comparator: Polyurethane Assigned polyurethane insole |
Device: Orthotic
Arch support orthotic
|
| Active Comparator: Polyethylene assigned polyethylene insole |
Device: Orthotic
Arch support orthotic
|
Outcome Measures
Primary Outcome Measures
- PROMIS-Pain interference [Baseline, 2nd-, 6th-, and 12th-week follow-ups]
measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities
- PROMIS-Pain intensity [Baseline, 2nd-, 6th-, and 12th-week follow-ups]
assesses how much a person hurts. Patients are usually able to provide quantitative pain intensity estimates relatively quickly
Secondary Outcome Measures
- Foot and Ankle Outcome Score [Baseline, 2nd-, 6th-, and 12th-week follow-ups]
a 42-item questionnaire with 5 subscales: pain (9 items), other symptoms (7 items), activities of daily living (ADL) (17 items), sports/recreation (5 items), and quality of life (4 items
- Visual Analogue Scale for pain [Baseline, 2nd-, 6th-, and 12th-week follow-ups]
A Visual Analogue Scale (VAS) is one of the pain rating scales
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Massachusetts General Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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
- 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
- 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.
- 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
- 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.
- 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.
- 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.
- 2021P003250