Orthoses for Plantar Fasciitis

Overseen By Rubens da Silva, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Université du Québec à Chicoutimi

Disqualifiers: Severe systemic diseases, tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how foot orthotics (special shoe inserts) can help people with plantar fasciitis, a condition causing severe heel pain. The goal is to determine if these orthotics improve balance, enhance walking, and reduce pain. Participants will be divided into two groups: one will use custom-made orthotics, and the other will not. Ideal candidates for the trial have experienced heel pain for over three months and feel discomfort after sitting or lying down. As an unphased trial, this study provides an opportunity to contribute to understanding how orthotics can alleviate heel pain and improve daily life.

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 prior data suggests that foot orthoses are safe for reducing plantar fasciitis pain?

Research has shown that foot orthoses, special shoe inserts, are generally safe and well-tolerated for people with plantar fasciitis. A review of various studies found that these inserts not only reduce pain but also improve foot function. No major safety concerns or negative effects were reported.

The main purpose of using orthoses is to provide better foot support, which can reduce pain and improve walking. As a non-invasive treatment, it typically avoids the risks associated with surgeries or medications. Overall, orthoses appear to be a safe option for managing foot pain from plantar fasciitis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using custom-made foot orthotics for plantar fasciitis because they offer a personalized approach to treatment. Unlike standard treatments such as over-the-counter insoles or anti-inflammatory medications, these orthotics are crafted based on individual foot impressions, allowing for tailored support and cushioning. This customization can potentially provide more effective pain relief and improved foot function, addressing the condition at its root by better aligning the foot during movement.

What evidence suggests that orthoses are effective for plantar fasciitis?

Research has shown that orthotics, which participants in this trial may receive, effectively treat plantar fasciitis, with 89% of people experiencing reduced pain. Studies also find that wearing orthotics can improve walking ability and increase the distance walked without pain. Arch supports provide the right cushioning and support for feet, preventing further injuries and reducing pain. Overall, foot orthotics have been proven to improve balance and make everyday activities more comfortable by easing foot pain. ^{1 6 7 8 9}

Who Is on the Research Team?

Rubens da Silva, PhD

Principal Investigator

Université du Québec à Chicoutimi

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Orthosis

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Université du Québec à Chicoutimi

Lead Sponsor

Trials

7

Recruited

320+

Published Research Related to This Trial

Foot orthoses show moderate-quality evidence for reducing pain in adults with plantar heel pain over a medium-term period (7 to 12 weeks), but there is uncertainty about the clinical significance of this change.

In the short term (0 to 6 weeks) and long term (13 to 52 weeks), there is very low-quality evidence indicating that foot orthoses do not significantly reduce pain or improve function, and no differences were found between customized and prefabricated orthoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foot orthoses for plantar heel pain: a systematic review and meta-analysis. Whittaker, GA., Munteanu, SE., Menz, HB., et al.[2022]

In a study of 255 participants with plantar fasciitis, no significant differences in pain relief were found among custom-made orthoses, over-the-counter arch supports, and tension night splints after 3 months of treatment.

However, custom-made orthoses resulted in the highest patient compliance, suggesting they may be better tolerated compared to the other treatments, which led to more early withdrawals due to pain or discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical treatment of plantar fasciitis. A prospective study. Martin, JE., Hosch, JC., Goforth, WP., et al.[2022]

Foot orthoses, specifically prefabricated and customized types, provide small short-term improvements in function and pain relief for individuals with plantar fasciitis, as shown in a trial with 135 participants over 12 months.

However, these orthoses do not demonstrate long-term benefits compared to a sham device, indicating that while they may help initially, their effectiveness diminishes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. Landorf, KB., Keenan, AM., Herbert, RD.[2022]

In a study of 60 participants with unilateral plantar fasciopathy, those using custom foot orthoses in new athletic shoes experienced significantly less first-step pain after 12 weeks compared to those using new shoes alone or a sham insole.

The custom orthoses not only reduced first-step pain but also led to a decrease in plantar fascia thickness, indicating a potential mechanism for their effectiveness in treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom foot orthoses improve first-step pain in individuals with unilateral plantar fasciopathy: a pragmatic randomised controlled trial. Bishop, C., Thewlis, D., Hillier, S.[2023]

Custom-made foot orthoses (CFOs) with a heel plug (HP) significantly reduce plantar pressures in the hindfoot, which is beneficial for conditions like plantar fasciitis, as it helps decrease pain and improve function.

While the HP orthosis effectively offloads pressure in the hindfoot, it tends to increase pressure in the midfoot and forefoot, indicating a trade-off that may need to be considered in treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom-made foot orthoses with and without heel plugs and their effect on plantar pressures during treadmill walking. Balsdon, MER., Dombroski, CE.[2022]

Contoured sandals significantly increase the medial longitudinal arch height compared to barefoot and flat sandals, suggesting they can effectively support foot health, as shown in studies with 21 healthy participants across two experiments.

The elevation in arch height achieved by contoured sandals is comparable to that of traditional in-shoe orthoses, indicating that they can be a viable alternative for individuals needing arch support.

NCBI (Pubmed)

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. Escalona-Marfil, C., McPoil, TG., Mellor, R., et al.[2021]

In a study of 77 patients with plantar fasciitis, custom foot orthoses (CFO) significantly improved overall foot function compared to prefabricated foot orthoses (PFO) and sham treatments, with a notable increase in spontaneous physical activity by 5.6 times for the CFO group.

Both CFO and PFO groups reported reduced morning and evening pain, but the CFO group also showed better balance and longer walking durations, indicating that custom orthoses may enhance functional mobility beyond just pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain. Wrobel, JS., Fleischer, AE., Crews, RT., et al.[2022]

In a study of 30 subjects with unilateral plantar fasciitis, both pre-fabricated orthotics and customised orthotics significantly reduced peak rearfoot pressures, improving pressure distribution compared to flat insoles and bone spur pads.

Bone spur heel pads were found to be ineffective, as they actually increased rearfoot peak pressures, highlighting the importance of using appropriate orthotic devices for managing plantar fasciitis.

NCBI (Pubmed)

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. Chia, KK., Suresh, S., Kuah, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10659571/

Enhancing Functional Rehabilitation Through Orthotic ... Studies indicate that orthotics are highly effective, with an 89% success rate in reducing pain associated with plantar fascia degeneration [9].

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6311243/

Effectiveness of Foot Biomechanical Orthoses to Relieve ... Indeed, pain is reduced, gait is improved, and walking distance is increased in individuals with plantar fasciitis wearing flat insoles [14–20].

3. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X23001224

Understanding flat feet: An in-depth analysis of orthotic ... Arch supports can help prevent injuries and foot problems such as overpronation, flat feet, and plantar fasciitis by providing proper support and cushioning to ...

4. runrepeat.com runrepeat.com/arch-support-study

The Truth About Arch Support - A Meta Analysis of 150 ... Studies have shown a reduction in pain after using arch support, mainly because arch support provides a cushion to the affected area. Neutral ...

5. ospublishers.com ospublishers.com/The-Effectiveness-of-Foot-insoles-Orthosis-on-the-Recovery-Process-of-Plantar-Fasciitis-Symptoms-and-Quality-of-Life-among-Health-Care-Providers.html

The Effectiveness of Foot-insoles Orthosis on the Recovery ... The results showed that 42 (45.2%) of the participants used the foot-orthosis (Insole/heel cushion) and 51(45.8) did not use it. Out of the 42 participants who ...

6. researchgate.net researchgate.net/publication/395884953_Efficacy_and_safety_of_foot_orthoses_for_improving_pain_and_function_in_patients_with_plantar_fasciitis_a_systematic_review_and_meta-analysis_of_randomized_controlled_trials

Efficacy and safety of foot orthoses for improving pain ... Efficacy and safety of foot orthoses for improving pain and function in patients with plantar fasciitis: a systematic review and meta-analysis ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10514714/

Use of orthotics with orthotic sandals versus the sole use ... Combined use of prefabricated orthotics and orthotic sandals provides a greater decrease in foot pain and improvement in foot function in PF compared to using ...

8. amazon.com amazon.com/PCSsole-Plantar-Fasciitis-Insoles-Orthotic/dp/B0CY5B75FR

PCSsole Plantar Fasciitis Insoles Men Women- 220+lbs ... HEAVY DUTY SUPPORT INSOLES: Powerful shoe inserts with 1.4 inches arch for men and women over 220 pounds help distribute body weight, and reduce foot impact.

9. molinahealthcare.com molinahealthcare.com/providers/sc/medicaid/PDF/Foot-Orthotics-Plantar-Fasciitis-Heel-Spurs-MCG-084.pdf

A limb orthosis (brace) is a device intended for medical ... Custom orthotics may not be authorized for plantar fasciitis or heel spurs. Studies of custom foot orthotics in adult or pediatric members have ...