Orthoses for Plantar Fasciitis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Université du Québec à Chicoutimi

Disqualifiers: Severe systemic diseases, tumors, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Foot pain is common in the general population. Plantar fasciopathy may affect 7% of the population at some time in their lives, but the incidence increases with age. This plantar problem is characterized by severe pain under the foot (at plantar level), which can be very incapacitating and disabling. This can lead to absenteeism from work, particularly for employees working in a standing posture. Various therapeutic avenues can be used to reduce pain and improve functionality, such as physiotherapy, infiltrations and surgery. In this research project, the propose the use of a conservative approach through the use of foot orthoses, which appears to be effective in reducing pain. The aim of the study is thus to better understand the effect of foot orthoses on postural balance and walking in workers with plantar fasciopathy. Participants will be assessed at baseline and eight weeks later to observe measured changes and clinical improvements following orthotic wear. Balance and gait pattern will be assessed using technological tools that have been validated in this respect. Participants will also be asked about their pain intensity. The hypothesis is that wearing the orthosis will improve the participants' balance and walking abilities, as well as reduce the level or intensity of their pain. In addition, this study could have an impact on the rate of absenteeism from work from current context of labour shortages.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Orthosis, Foot Orthotics, Arch Supports, In-Shoe Heel Cushioning for plantar fasciitis?

Research shows that foot orthoses, including custom-made ones, can improve pain scores for plantar fasciitis. Custom-made orthoses also had the highest patient compliance compared to other treatments, suggesting they are well-tolerated and potentially effective.

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How does the orthosis treatment for plantar fasciitis differ from other treatments?

Orthosis treatment for plantar fasciitis is unique because it involves custom-made foot supports that can be tailored to individual needs, potentially improving pain by supporting the foot's arch and reducing stress on the plantar tissues. Unlike other treatments, orthoses can be integrated into various types of footwear, including sandals, offering flexibility and convenience for users.

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Eligibility Criteria

This trial is for adults aged 20-65 who are currently working and have been experiencing heel pain for over three months due to plantar fasciopathy. Participants should have a pain level of at least 3 out of 10 and post-static dyskinesia, which is pain after rest.

Inclusion Criteria

I have been diagnosed with plantar fasciitis.

I have had heel pain for over 3 months.

I experience heel pain of at least a moderate level.

Exclusion Criteria

I have a serious illness that affects my whole body.

I have deformities in my legs.

I have no signs of serious conditions like tumors.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are assessed for postural control, gait measures, ankle mobility, and pain levels

1 week

1 visit (in-person)

Treatment

Participants in the experimental group receive custom-made foot orthotics

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in postural control, gait, ankle mobility, and pain levels

1 week

1 visit (in-person)

Participant Groups

The study tests the effectiveness of foot orthoses in improving balance, walking abilities, and reducing heel pain intensity in workers with plantar fasciopathy. Assessments will be made before starting the treatment and eight weeks later using validated technological tools.

Group I: Othesis intervention Experimental Treatment 1 Intervention

This group with custom-made foot orthotics prescribed by podiatrists (foot impression, polypropylene orthotics and covering at podiatrists' discretion).

Group II: Control group Active Control 1 Intervention

Without orthesis prescriptions by podiatrists.

Orthosis is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Orthotics for:

• Plantar Fasciitis
• Foot Pain
• Ankle Support

🇺🇸 Approved in United States as Orthotics for:

• Plantar Fasciitis
• Foot Pain
• Ankle Support
• Postural Control Improvement

🇨🇦 Approved in Canada as Orthotics for:

• Plantar Fasciitis
• Foot Pain
• Ankle Support

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Rubens da Silva Saguenay, Canada

Who Is Running the Clinical Trial?

Université du Québec à Chicoutimi Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Foot orthoses for plantar heel pain: a systematic review and meta-analysis. [2022] To investigate the effectiveness of foot orthoses for pain and function in adults with plantar heel pain.

2. France pubmed.ncbi.nlm.nih.gov

Custom-made foot orthoses with and without heel plugs and their effect on plantar pressures during treadmill walking. [2022] Foot orthoses have consistently demonstrated an improvement in pain scores for plantar fasciitis. The fabrication of custom-made foot orthoses (CFOs) can vary between clinicians and may include the use of different materials and casting techniques. This cross-sectional study's objective was to quantify plantar pressure for two CFOs, one with a heel plug (HP) and one without.

3. United States pubmed.ncbi.nlm.nih.gov

Mechanical treatment of plantar fasciitis. A prospective study. [2022] A randomized, prospective study was conducted to compare the effectiveness of three individual mechanical modalities in the treatment of plantar fasciitis. Two hundred fifty-five subjects were randomly assigned to one of three treatment groups: custom-made orthoses, over-the-counter arch supports, or tension night splints. Subjects were treated for 3 months, with follow-up visits at 2, 6, and 12 weeks. No statistically significant difference was noted among treatment groups with respect to final outcomes based on first-step pain or pain felt during the day. However, there was a statistically significant difference among the three groups with respect to early patient withdrawal from the study due to continued severe pain, noncompliance, or inability to tolerate the device. Patient compliance was greatest with the use of custom-made orthoses.

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. [2022] Plantar fasciitis is one of the most common foot complaints. It is often treated with foot orthoses; however, studies of the effects of orthoses are generally of poor quality, and to our knowledge, no trials have investigated long-term effectiveness. The aim of this trial was to evaluate the short- and long-term effectiveness of foot orthoses in the treatment of plantar fasciitis.

5. Singapore pubmed.ncbi.nlm.nih.gov

Comparative trial of the foot pressure patterns between corrective orthotics,formthotics, bone spur pads and flat insoles in patients with chronic plantar fasciitis. [2022] The objective of the study is to compare the efficacy of fl at insoles, bone spur pads, pre-fabricated orthotics and customised orthotics in reducing plantar contact pressure of subjects with plantar fasciitis.

6. England pubmed.ncbi.nlm.nih.gov

Custom foot orthoses improve first-step pain in individuals with unilateral plantar fasciopathy: a pragmatic randomised controlled trial. [2023] Foot orthoses are routinely used to treat plantar fasciopathy in clinical practice. However, minimal evidence exists as to the effect of both truly custom designed foot orthoses, as well as that of the shoe the foot orthoses are placed into. This study investigated the effect of wearing custom foot orthoses and new athletic footwear on first-step pain, average 24-h pain and plantar fascia thickness in people with unilateral plantar fasciopathy over 12 weeks.

7. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain. [2022] Up to 10% of people will experience heel pain. The purpose of this prospective, double-blind, randomized clinical trial was to compare custom foot orthoses (CFO), prefabricated foot orthoses (PFO), and sham insole treatment for plantar fasciitis.

8. England pubmed.ncbi.nlm.nih.gov

A radiographic and anthropometric study of the effect of a contoured sandal and foot orthosis on supporting the medial longitudinal arch. [2021] In-shoe foot orthoses improve conditions such as plantar heel pain (fasciitis), probably due to their ability to raise the medial longitudinal arch of the foot and lower the stress on the plantar tissues. Increasingly the arch-profile form of the in-shoe foot orthosis is being incorporated into sandal footwear, providing an alternative footwear option for those who require an orthosis. The purpose of this study was to evaluate if a sandal that incorporates the arch-profile of an in-shoe foot orthosis does indeed raise the medial longitudinal arch.