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

24 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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]

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]

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 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]

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]

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]

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]

Citations

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

Foot orthoses for plantar heel pain: a systematic review and meta-analysis. [2022]

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]

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

Mechanical treatment of plantar fasciitis. A prospective study. [2022]

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

Effectiveness of foot orthoses to treat plantar fasciitis: a randomized trial. [2022]

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]

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]

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

A randomized controlled trial of custom foot orthoses for the treatment of plantar heel pain. [2022]

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]