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Plantar FasciitisNCT06116799

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

A study testing Orthotic in people with Plantar Fasciitis, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plantar Fasciitis
What is being tested?
Orthotic
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
1 Apr 2022to 6 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Read the 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.

Being tested
Orthotic
Medical subject headings
Fasciitis, Plantar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrthoticDevice

    Arch support orthotic

Study groups in NCT06116799
Study groupRoleWhat they receive
Carbon fiber insoleExperimentalassigned carbon fiber insole
Receives: Device: Orthotic
PolyurethaneActive comparatorAssigned polyurethane insole
Receives: Device: Orthotic
PolyethyleneActive comparatorassigned polyethylene insole
Receives: Device: Orthotic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PROMIS-Pain interference

    measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities

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

  2. PROMIS-Pain intensity

    assesses how much a person hurts. Patients are usually able to provide quantitative pain intensity estimates relatively quickly

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

Secondary outcomes (2)

  1. 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

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

  2. Visual Analogue Scale for pain

    A Visual Analogue Scale (VAS) is one of the pain rating scales

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2023
  2. Study start1 Apr 2022
  3. Primary completion6 May 2023
  4. Study completion6 May 2023

Why it stopped: Sufficient power;slowed enrollment pace;budget restraints

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06116799
Sponsor's protocol ID
2021P003250
Status last verified
Oct 2023
First submitted
31 Oct 2023
Last updated
3 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 33233945

  • 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

  • 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

  • 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.

    PubMed 32527296

  • 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.

    PubMed 18646168

  • 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.

    PubMed 19218074

Questions about this trial

What is this clinical trial studying?

A study testing Orthotic in people with Plantar Fasciitis, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Sufficient power;slowed enrollment pace;budget restraints). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PROMIS-Pain interference (time frame: Baseline, 2nd-, 6th-, and 12th-week follow-ups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06116799, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.

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