Night Splinting for Plantar Fasciitis

Recruiting at 1 trial location

Overseen By Prerna Arora

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Narcotics

Disqualifiers: Arthritis, Gout, Tendonitis, Fibromyalgia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two types of night splints to treat plantar fasciitis, a painful foot condition that often causes heel pain, especially after resting. Researchers aim to determine if these splints differ in improving foot movement. One group will use a conventional static splint, while the other will try a dynamic splint, which might replace wearing a bulky boot. The trial seeks participants who have had plantar fasciitis for less than six months, experience heel pain after resting, and have not used narcotics or required previous surgery for their condition. As an unphased trial, this study offers a unique opportunity to contribute to understanding new treatment options for plantar fasciitis.

Will I have to stop taking my current medications?

The trial allows the use of icing, NSAIDs (like ibuprofen), and custom shoe inserts. It does not specify if you need to stop other medications, so it's best to ask the trial organizers for more details.

What prior data suggests that these splinting methods are safe for treating plantar fasciitis?

Research has shown that dynamic splints are generally safe for treating plantar fasciitis. One study found that using a dynamic splint effectively reduces pain from plantar fasciitis, suggesting it could be a helpful part of regular treatment. Another study demonstrated that the design of the dynamic splint provides a gentle, continuous stretch, which helps reduce discomfort and makes it easier for users to continue the treatment. While these studies highlight the benefits, they also indicate that dynamic splints are well-tolerated, with no serious safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for plantar fasciitis, like static splints that hold the foot in one position overnight, dynamic splints offer more flexibility and movement. Researchers are excited about dynamic splinting because it allows for controlled stretching of the plantar fascia, potentially enhancing comfort and effectiveness by adapting to the foot's natural movements. This innovative approach might reduce pain and improve function more quickly than conventional methods.

What evidence suggests that dynamic splinting is effective for plantar fasciitis?

Research has shown that wearing night splints can reduce pain and improve movement for people with plantar fasciitis. In one study with 116 patients, adding night splints to their treatment plan effectively reduced heel pain. Another review found that night splints not only relieve pain but also improve foot movement. This trial will compare two types of splints: dynamic splints, which allow some movement, and static splints, which keep the foot still. Dynamic splints, which participants in this trial may receive, have proven especially helpful compared to static splints. Overall, using a night splint, particularly a dynamic one, can ease the symptoms of plantar fasciitis. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with acute plantar fasciitis, experiencing heel pain that worsens with weightbearing and improves slightly after walking. Participants must be able to walk without aids and not have a history of narcotic use. They can use ice, NSAIDs like ibuprofen, custom shoe inserts, or diagnostic ultrasound.

Inclusion Criteria

I have been diagnosed with acute plantar fasciitis.

I am allowed to use ice, ibuprofen, custom shoe inserts, and have diagnostic ultrasounds.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either static or dynamic splinting for plantar fasciitis

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Dynamic splint

Trial Overview

The study is examining if there's a difference in improving motion between two types of night splints for plantar fasciitis: static progressive (non-moving) and dynamic (moving). The goal is to see which one helps better with flexibility and pain relief.

How Is the Trial Designed?

Group I: Experiment( dynamic splinting) Experimental Treatment 1 Intervention

Device treats plantar fasciitis and replacing boot immobilization

Group II: Control( static splinting) Active Control 1 Intervention

conventional static splint

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a study of 44 patients with plantar fasciitis, those who used a night splint showed significantly greater improvements in pain relief and function after two months compared to those who did not use the splint.

Despite the short-term benefits of using a night splint, the study found no significant effect on preventing recurrences of heel pain over a two-year follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of dorsiflexion night splint added to conservative treatment for plantar fasciitis]. Beyzadeoğlu, T., Gökçe, A., Bekler, H.[2019]

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]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/10613168/

Night splint treatment for plantar fasciitis. A prospective ...

A prospective randomized study of 116 patients with plantar fasciitis was performed to determine the effectiveness of adjuvant night splint therapy.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01588730

Dynamic and Static Splinting as a Treatment for Plantar ...

The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to static night splint for the reduction of pain from Plantar Fasciitis ( ...

3.

mltj.online

mltj.online/wp-content/uploads/2023/05/12.FLOR-BERTOLINI.pdf

Night Splints in Plantar Fasciitis: A Systematic Review

It is concluded that the use of the night splint improves pain and func- tion in individuals with plantar fasciitis.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05432895

Dynamic Versus Static Night Splinting of Plantar Fasciitis

The investigators are trying to study that there is no difference in improvement of motion between static progressive and dynamic splinting. Detailed ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/17876122/

[The effectiveness of dorsiflexion night splint added to ...

Conclusion: Patients without previous treatments for plantar fasciitis obtain significant relief of heel pain in the short term with the use of a night splint ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/20479445/

Plantar fasciopathy treated with dynamic splinting

Conclusions: Dynamic splinting was effective for reducing the pain of plantar fasciopathy, and this modality should be included in the standard of care for ...

7.

journals.humankinetics.com

journals.humankinetics.com/view/journals/jsr/29/5/article-p657.xml

Effectiveness of Mechanical Treatment for Plantar Fasciitis

The aim of this study is to provide an overview of the effectiveness of all commonly used mechanical treatment options for plantar fasciitis.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S135045331100275X

Design and validation of a dynamic stretch splint for plantar ...

The findings indicated that the designed splint could provide a continuous load of stretch, eliminate discomfort and increase user compliance comparing to ...