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

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT06116799
• Other study ID #: 2021P003250
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 6, 2023

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: May 6, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• Orthotic
Arch support orthotic

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS-Pain interference	measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities	Baseline, 2nd-, 6th-, and 12th-week follow-ups
Primary	PROMIS-Pain intensity	assesses how much a person hurts. Patients are usually able to provide quantitative pain intensity estimates relatively quickly	Baseline, 2nd-, 6th-, and 12th-week follow-ups
Secondary	Foot and Ankle Outcome Score	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	Baseline, 2nd-, 6th-, and 12th-week follow-ups
Secondary	Visual Analogue Scale for pain	A Visual Analogue Scale (VAS) is one of the pain rating scales	Baseline, 2nd-, 6th-, and 12th-week follow-ups