Customized Foot Orthoses for Ball of Foot Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether special shoe inserts, called foot orthoses (FOs), can reduce pain and improve foot function for people with chronic ball of foot pain (metatarsalgia). One group will receive custom FOs designed to reduce pressure on the painful area, while another group will receive sham inserts that offer no special support. The trial aims to determine if the custom FOs are more effective than the sham ones. It suits individuals who have experienced ball of foot pain for at least three months, especially when standing or walking, and who can walk without aids like canes. Participants should be willing to wear shoes that accommodate the inserts daily and limit other pain treatments during the trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding how foot orthoses can alleviate foot pain and improve daily life.
Will I have to stop taking my current medications?
The trial asks participants to minimize the use of other interventions like pain medications during the trial period, so you may need to reduce your current medication use.
What prior data suggests that these foot orthoses are safe for managing ball of foot pain?
Research has shown that custom foot orthoses (FOs), special shoe inserts, can reduce pain and improve foot function for those with chronic metatarsalgia, a condition causing pain in the ball of the foot. Studies have found these inserts to be generally easy to use. For instance, one study noted that individuals using custom FOs experienced less pain when taking their first steps in the morning after just four weeks.
The studies reviewed report no serious side effects from using custom FOs, suggesting they are safe for most people. However, as with any treatment, some individuals might experience mild discomfort while adjusting to the inserts.
In summary, custom FOs seem to be a safe way to reduce foot pain, but consulting a healthcare provider about any concerns before starting treatment is always wise.12345Why are researchers excited about this trial?
Unlike the standard care for ball of foot pain, which often includes over-the-counter orthotics or pain medication, customized foot orthoses (FOs) offer a tailored fit specifically designed for an individual's foot structure. Researchers are excited about this treatment because personalized orthotics can potentially provide more precise support and relief, addressing the root cause of pain rather than just the symptoms. Additionally, these custom orthoses aim to improve overall foot function and comfort, which could lead to better long-term outcomes compared to generic options.
What evidence suggests that these foot orthoses could be effective for ball of foot pain?
Research has shown that custom foot orthotics (special shoe inserts) with a metatarsal pad can reduce pain and improve foot function for people with chronic metatarsalgia (foot pain). One study found that these custom inserts moderately reduced pressure on the front part of the foot, often linked to pain. Another study showed that 68% of patients experienced pain relief after using the inserts for several months. The custom design and fit of these inserts are crucial for comfort and effective pain reduction. In this trial, participants in the intervention group will receive customized foot orthoses, while those in the control group will receive sham foot orthoses. Overall, evidence suggests that custom orthotics can effectively manage foot pain related to metatarsalgia.15678
Are You a Good Fit for This Trial?
This trial is for individuals with chronic forefoot pain, specifically metatarsalgia, lasting at least 3 months and causing significant discomfort during weight-bearing activities. Participants must be able to walk unaided and agree to wear accommodating shoes for the foot orthoses daily while minimizing other treatments.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo baseline assessment including demographic and clinical data collection
Treatment
Participants receive either customized foot orthoses or sham orthoses
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Custom Foot Orthoses
- Sham Foot Orthoses
Trial Overview
The study compares custom medially wedged foot orthoses with a metatarsal pad against sham (placebo) orthoses in reducing pain and improving foot function. It's a blinded randomized controlled trial assessing outcomes at baseline, after 6 weeks, and after 12 weeks.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants randomized to the intervention group will receive customized FOs for both feet.
Participants randomized to the control group will receive sham FOs for both feet.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Université du Québec à Trois-Rivières
Lead Sponsor
Fonds de la Recherche en Santé du Québec
Collaborator
Citations
Custom foot orthoses for chronic metatarsalgia: Study protocol ...
Medially wedged FOs with a metatarsal pad are expected to provide a greater reduction in pain and improvement in foot function compared to sham ...
Systematic review on the comparative effectiveness of foot ...
A medium effect for (immediate) reduction of forefoot plantar pressure was found in favor of treatment with soft FOs compared to semi-rigid FOs ...
Assessing the Acceptability and Effectiveness of a Novel ...
Conclusion: This study underscores the significance of de- sign and custom fit in promoting continuous wear for ef- fective foot pain reduction ...
The Effect of Metatarsal Padding on Pain and Functional ...
The average duration of insole use was 11.2 months (range 1 month to 3 years). Insole treatment was considered beneficial by 68% of our patients ...
Custom foot orthoses for chronic metatarsalgia: study ...
Effectiveness of custom-made foot orthoses for treating forefoot pain: a systematic review. Int Orthop2018. p. 1865-75. 21. Moher D ...
Randomized Controlled Trial of Custom Foot Orthoses for ...
... data collection). The primary outcomes will be: (1) "pain" subscale of the Foot Function Index and (2) mean pain during walking for the most painful foot ...
(PDF) Custom foot orthoses improve first-step pain in ...
Outcomes were assessed at baseline, 4 week and 12 week trial time-points. Results: At 4 weeks, the orthoses group reported less first-step pain (p = 0.002) ...
Foot Orthotics - Medical Clinical Policy Bulletins
Accommodative foot orthoses are custom or non-custom inlays fabricated for the purpose of providing relief from callosities and pressure points, and maintaining ...
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