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

Trial Summary

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 data supports the effectiveness of the treatment Dynamic splint for plantar fasciitis?

The research shows that while night splints, including dynamic splints, are commonly used for plantar fasciitis, they do not provide significant additional benefits in pain relief or function when added to other treatments. However, one study found that a combination of night splints and shoe modifications resolved symptoms in 59% of cases, suggesting some potential benefit. ^{1 2 3 4 5}

Is night splinting for plantar fasciitis safe for humans?

The studies reviewed do not report any specific safety concerns related to the use of night splints for plantar fasciitis, suggesting they are generally safe for human use. ^{1 2 3 6 7}

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

The dynamic splint treatment for plantar fasciitis is unique because it involves wearing a special brace at night that keeps the foot in a stretched position, which can help alleviate pain and improve function without the need for medications or injections. This approach is particularly useful for those who have not found relief with other treatments like anti-inflammatory drugs or physical therapy. ^{1 2 8 9 10}

What is the purpose of this trial?

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

The addition of a tension night splint to a structured home rehabilitation programme in patients with chronic plantar fasciitis does not lead to significant additional benefits in either pain, function or flexibility: a single-blinded randomised controlled trial. [2022]

2. Turkey pubmed.ncbi.nlm.nih.gov

[The effectiveness of dorsiflexion night splint added to conservative treatment for plantar fasciitis]. [2019]

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

Plantar fasciitis: a prospective randomized clinical trial of the tension night splint. [2022]

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

Treatment of plantar fasciitis with a night splint and shoe modification consisting of a steel shank and anterior rocker bottom. [2017]

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

Night splint treatment for plantar fasciitis. A prospective randomized study. [2022]

6. 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]

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

Foot orthoses for the treatment of plantar fasciitis. [2022]

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

Effective treatment of chronic plantar fasciitis with dorsiflexion night splints: a crossover prospective randomized outcome study. [2022]

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

The use of night splints for treatment of recalcitrant plantar fasciitis. [2022]

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

Podiatric medical applications of posterior night stretch splinting. [2019]