Stretching Device vs Night Splints for Heel Spur Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments to determine which is more effective for plantar fasciitis, a common foot condition causing heel pain. Participants will use either night splints, which keep the foot stretched during sleep, or a new device called the Triceps Surae Stretching and Flexibility Assessment Device (TESS), designed to stretch the calf muscles. After six weeks of using the assigned treatment, participants will complete a questionnaire about their symptoms. The study seeks individuals diagnosed with plantar fasciitis who can safely use the assigned device after some training. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance treatment options for plantar fasciitis.
What prior data suggests that the night splints and TESS device are safe for treating plantar fasciitis?
Studies have shown that night splints are generally well-received by people with plantar fasciitis. Specifically, 68% of patients reported improvement after using night splints for 12 weeks. These studies found no major side effects, suggesting that night splints are safe for most people.
Research on the Triceps Surae Stretching and Flexibility Assessment Device (TESS) is less extensive, but similar stretching exercises have been studied. These exercises have reduced pain and improved movement in people with plantar fasciitis. While specific data on the TESS device itself is limited, the stretching exercises it supports are generally safe and effective.
Both treatments have been well-tolerated, with studies reporting no significant negative effects.12345Why are researchers excited about this trial?
Researchers are excited about the Triceps Surae Stretching and Flexibility Assessment Device (TESS) because it offers a novel approach to treating plantar fasciitis. Unlike traditional night splints, which immobilize the foot during sleep to relieve symptoms, TESS actively engages the triceps surae muscle group, which includes the calf muscles, to enhance flexibility and stretch the plantar fascia more effectively. This dynamic stretching mechanism could potentially provide more personalized and effective relief by addressing the root cause of the tightness, rather than just managing symptoms.
What evidence suggests that night splints and the TESS device could be effective for plantar fasciitis?
This trial will evaluate two treatments for plantar fasciitis: night splints and the Triceps Surae Stretching and Flexibility Assessment Device (TESS). Research has shown that night splints can effectively treat plantar fasciitis, with studies finding that about 68-88% of patients experience less heel pain when using them. These devices keep the foot stretched during sleep, promoting healing and reducing swelling.
In contrast, TESS is a new method focusing on stretching the calf muscles. Stretching exercises have been shown to reduce pain and improve movement in people with plantar fasciitis. Although direct evidence for TESS specifically is limited, stretching is often recommended for this condition and has proven beneficial in similar treatments. Participants in this trial will use either night splints or TESS to address their plantar fasciitis symptoms.12467Who Is on the Research Team?
Mike Davis, MD
Principal Investigator
SAE Orthopedics
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use either night splints or the AcuFlex device for 6 weeks to treat plantar fasciitis symptoms
Follow-up
Participants return their device and complete a follow-up questionnaire to assess symptoms and pain levels
What Are the Treatments Tested in This Trial?
Interventions
- Night splints
- Triceps Surae Stretching and Flexibility Assessment Device (TESS)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
This is the only arm of the study. It is a 6 week period where the participants will either be using night splints or the AcuFlex device to treat their plantar fasciitis symptoms.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SAE Orthopedics
Lead Sponsor
Citations
[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 ...
The effect of night splints in the treatment of plantar fasciitis
Plantar fascia-specific stretching exercise improves outcomes in patients with chronic plantar fasciitis. A prospective clinical trial with two- ...
Night Splints in Plantar Fasciitis: A Systematic Review
Therefore, the use of these orthoses (splints), by placing the joint in an anatomical position, results in a decrease in contracture (10, 21, 22). Therefore, ...
Effectiveness of Mechanical Treatment for Plantar Fasciitis
AFOs seem to be as effective as insoles or stretching, but combining night splints and insoles led to enhanced improvements in pain and function ...
Night splint treatment for plantar fasciitis. A prospective ...
Overall, 68% of patients reported improvement with this nonoperative protocol for a 12-week period. No statistical difference was seen with the presence or ...
Conservative therapy for plantar fasciitis: a narrative review of ...
59.5% indicated satisfaction with the treatment, 13.5% were satisfied with reservations. MCSS scores improved significantly when groups used the night splint.
Treatment of Plantar Fasciitis With Dorsiflexion Night ...
The literature provides evidence to support the use of dorsiflexion night splints and medial arch supports in the treatment of plantar fasciitis ...
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