NCT06116799

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
Last Updated

November 3, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

October 31, 2023

Last Update Submit

October 31, 2023

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Foot and Ankle Outcome Score

    Baseline, 2nd-, 6th-, and 12th-week follow-ups

  • Visual Analogue Scale for pain

    Baseline, 2nd-, 6th-, and 12th-week follow-ups

Study Arms (3)

Carbon fiber insole

EXPERIMENTAL

assigned carbon fiber insole

Device: Orthotic

Polyurethane

ACTIVE COMPARATOR

Assigned polyurethane insole

Device: Orthotic

Polyethylene

ACTIVE COMPARATOR

assigned polyethylene insole

Device: Orthotic

Interventions

OrthoticDEVICE

Arch support orthotic

Carbon fiber insolePolyethylenePolyurethane

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (7)

  • 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.

    PMID: 33233945BACKGROUND

  • 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

    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

    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

    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.

    PMID: 32527296BACKGROUND

  • 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;2008(3):CD006801. doi: 10.1002/14651858.CD006801.pub2.

    PMID: 18646168BACKGROUND

  • 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.

    PMID: 19218074BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Orthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Foot and Ankle Research and Innovation Laboratory

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 3, 2023

Study Start

April 1, 2022

Primary Completion

May 6, 2023

Study Completion

May 6, 2023

Last Updated

November 3, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

All data acquired as specified by this protocol will be maintained and monitored by approved study staff. Approved study staff will be responsible for collecting the signed consent forms. All electronic data and subject information will be secured on non-networking password protected computers; all paperwork will be secured in locked filing cabinets. All electronic data and subject information will be secured in REDCap and will be secured on non-networking password protected computers to which only study staff will have access; all paper work will be secured in locked filing cabinets.

Locations

US(1)