3D-Printed Orthotics for Plantar Fasciitis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Prisma Health-Midlands

Disqualifiers: Orthotic use, Neuropathy, Fractures, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new method using 3D printing to make custom foot inserts for people with plantar fasciitis. It aims to see if these inserts work better than traditional ones and if patients are satisfied with them. 3D printed foot orthoses have been shown to be effective in treating various foot conditions, including plantar fasciitis, by improving foot biomechanics and comfort.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of 3D-Printed Orthotics for Plantar Fasciitis treatment?

Research shows that customized 3D-printed orthotics can improve foot comfort and reduce pressure in specific areas of the foot for people with plantar fasciitis, making them more effective than traditional orthotics. ^{1 2 3 4 5}

Is it safe to use 3D-printed orthotics for plantar fasciitis?

Research on 3D-printed orthotics, including those for plantar fasciitis, suggests they are generally safe for use in humans, as studies have focused on their effects on foot pressure and comfort without reporting significant safety concerns. ^{1 3 6 7 8}

How does the 3D-printed orthotics treatment for plantar fasciitis differ from other treatments?

The 3D-printed orthotics for plantar fasciitis are unique because they are customized to fit each individual's foot, improving comfort and pressure distribution compared to traditional prefabricated orthotics. This personalized approach can lead to better pain relief and foot function by specifically addressing the biomechanics of the plantar foot. ^{1 3 6 7 8}

Eligibility Criteria

This trial is for adults over 18 with plantar fasciitis who can communicate electronically. It's not suitable for non-English speakers, Medicare patients, pregnant women, those needing lower leg bracing, or individuals with a history of orthotic use or certain foot conditions.

Inclusion Criteria

Access to methods of electronic communication (i.e., email)

At least 18 years of age

You have been diagnosed with plantar fasciitis.

Exclusion Criteria

You have used or been prescribed orthotic inserts in the past.

You have been diagnosed with nerve damage, a recent broken bone, or a bone fracture caused by overuse or repetitive stress.

Non-English speakers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either traditionally fabricated orthotics or HP Arize 3D-printed orthotics for treatment of plantar fasciitis

8 weeks

3 visits (in-person)

Follow-up

Participants are monitored for compliance, satisfaction, and secondary site pain after initiation of orthotic wearing

8 weeks

2 visits (in-person)

Treatment Details

Interventions

• HP Arize 3D-Printed Orthotics
• Traditional Orthotics

Trial Overview The study compares the effectiveness and patient satisfaction between HP Arize 3D-printed orthotics and traditional custom-made ones in treating plantar fasciitis. Participants will receive one type to see which performs better.

Participant Groups

Group I: HP Arize 3D-Printed Orthotics Experimental Treatment 1 Intervention

Patients will receive the HP Arize 3D-printed orthotics for treatment of plantar fasciitis.

Group II: Traditional Orthotics Active Control 1 Intervention

Patients will receive traditionally fabricated orthotics for treatment of plantar fasciitis.

Who Is Running the Clinical Trial?

Prisma Health-Midlands

Lead Sponsor

Trials

24

Recruited

2,800+

Hewlett-Packard (HP)

Collaborator

Trials

1

Recruited

30+

Findings from Research

Customized 3D printed ankle-foot orthoses (AFOs) significantly improved comfort and reduced peak pressure in key areas of the foot for patients with plantar fasciitis compared to traditional prefabricated AFOs, as shown in a study of 60 patients over 8 weeks.

After 8 weeks, patients using the customized AFOs reported significantly greater comfort levels than those using prefabricated AFOs, indicating that customized solutions may be more effective in managing plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 3D Printing Individualized Ankle-Foot Orthosis on Plantar Biomechanics and Pain in Patients with Plantar Fasciitis: A Randomized Controlled Trial. Xu, R., Wang, Z., Ma, T., et al.[2020]

In a study involving 30 adults with plantar fasciitis, two types of prefabricated foot orthotics (soft supportive foam and foam covered rigid plastic) significantly reduced pain levels compared to a non-supportive orthotic, which showed no effect.

The foam covered rigid plastic orthotic was found to be the most effective, providing superior pain reduction and quicker onset of relief compared to the soft supportive foam orthotic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of different orthotic concepts as first line treatment of plantar fasciitis. Walther, M., Kratschmer, B., Verschl, J., et al.[2022]

In a study involving 142 adults with plantar fasciitis, both prefabricated and customized foot orthoses made from low-cost EVA foam showed significant improvement in pain after 8 weeks of use, indicating their effectiveness in treatment.

There was no significant difference in pain relief between the two types of orthoses, suggesting that low-cost prefabricated EVA inserts are a viable and effective option for treating uncomplicated plantar fasciitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. Baldassin, V., Gomes, CR., Beraldo, PS.[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]

The study involving 30 healthy male participants demonstrated that a customized 3D-printed heel support insole significantly reduced peak pressure under the heel compared to traditional insoles, indicating improved pressure distribution.

Using the customized insole did not negatively affect midfoot motion function, suggesting it can enhance comfort without compromising foot function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 3D-Printed Heel Support Insoles Based on Arch Lift Improves Foot Pressure Distribution in Healthy People. Jin, H., Xu, R., Wang, S., et al.[2020]

References

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

Effect of 3D Printing Individualized Ankle-Foot Orthosis on Plantar Biomechanics and Pain in Patients with Plantar Fasciitis: A Randomized Controlled Trial. [2020]

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

Effect of different orthotic concepts as first line treatment of plantar fasciitis. [2022]

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

Effectiveness of prefabricated and customized foot orthoses made from low-cost foam for noncomplicated plantar fasciitis: a randomized controlled trial. [2022]

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

Comparative Study of the Effects of Customized 3D printed insole and Prefabricated Insole on Plantar Pressure and Comfort in Patients with Symptomatic Flatfoot. [2020]

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

Effect of 3D printed foot orthoses stiffness on muscle activity and plantar pressures in individuals with flexible flatfeet: A statistical non-parametric mapping study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

3D printing individualized heel cup for improving the self-reported pain of plantar fasciitis. [2023]

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

Use of 3D-Printed Heel Support Insoles Based on Arch Lift Improves Foot Pressure Distribution in Healthy People. [2020]