New Trial to Test 3D-Printed Foot Orthoses for Chronic Foot Pain Treatment

Randomized Controlled Trial Will Evaluate Customized Foot Orthoses for Chronic Metatarsalgia

A new randomized controlled trial (RCT) scheduled to begin in January 2026 will evaluate the effectiveness of medially wedged customized foot orthoses (FOs) with metatarsal pads compared to sham devices for treating chronic metatarsalgia. The study, registered on ClinicalTrials.gov (Protocol ID: 2025_UQTR_FOs_RCT), aims to provide high-level evidence for conservative treatment of one of the most prevalent causes of foot pain.

Researchers from the Université du Québec à Trois-Rivières (UQTR) will conduct the participant- and assessor-blinded superiority trial, with results expected by August 2027. The study addresses a significant clinical need, as metatarsalgia represents 88% of all foot pain causes, with a prevalence of 13-36% in adults, yet lacks substantial high-level evidence for conservative treatments.

What Is the Study Design?

The trial will recruit 64 participants (32 per group) with chronic metatarsalgia lasting at least three months. Participants will be randomized to receive either customized 3D-printed FOs featuring a 6° medial wedge and metatarsal pad or sham orthoses providing negligible mechanical support. Both groups will follow identical clinical guideline-based information and support protocols.

What Are the Experts Saying?

"This research design allows us to determine whether, beyond their biomechanical effects, these orthoses provide meaningful clinical benefits for individuals suffering from chronic metatarsalgia," said the study coordinator. "By using a randomized controlled trial approach, we're establishing the gold standard of evidence that clinicians need for treatment recommendations."

How Will Outcomes and Challenges Be Addressed?

The primary outcome measure will be pain reduction during walking as measured by a visual analog scale (VAS), with secondary outcomes including the Foot Function Index, global rating of change, health-related quality of life using EQ-5D-5L, and plantar pressure measurements. The 12-week intervention period will include assessments at baseline, six weeks, and twelve weeks.

A distinctive feature of the study is the use of 3D printing technology to create the customized orthoses, representing the advancing intersection of digital manufacturing and personalized medical devices. The customized FOs will include a Nylon (PA11) shell with medially wedged forefoot-rearfoot posts of varying thickness based on participant weight, along with a full-length Poron top cover and strategically positioned metatarsal pad.

The study employs a minimization method with an 80:20 probabilistic element to ensure balanced groups regarding gender, age, and pain severity. This sophisticated randomization approach helps control for factors known to influence treatment response. Participants will be monitored throughout the trial with daily logs of FO wear time, with a minimum average of 3 hours per day required to remain in the study.

The research team has carefully designed the statistical analysis plan using linear mixed-effects models for the primary outcome analysis, with participants included as random effects and baseline scores and minimization factors as fixed covariates. This approach allows for the use of all available data even with missing outcomes, under the assumption that data are missing at random.

The study addresses several limitations of previous research, including the challenge of creating truly credible sham orthoses. The researchers note that while their sham devices are considered credible by patients, biomechanical analyses show they still reduce plantar pressure under the heel compared to shoes alone. To account for this, the team will conduct baseline biomechanical assessments to ensure the customized orthoses reduce pressure under the metatarsal heads while sham orthoses provide minimal effects.

"One strength of this trial is its direct applicability to clinical practice," noted a member of the research team. "The prescriptions and instructions given mirror those used in everyday clinical settings, which means the results can be readily implemented by practitioners."

How Could This Impact the Market and Future Practice?

Market implications extend beyond podiatry into the broader orthopedic and rehabilitation sectors. As conservative treatments gain favor for musculoskeletal conditions, high-quality evidence from RCTs becomes increasingly valuable for clinicians, payers, and medical device companies. The customized approach also aligns with growing trends toward personalized medicine and digital manufacturing in healthcare.

Industry Context: This trial reflects the medical device industry's shift toward evidence-based product development and personalized treatment solutions. As healthcare systems worldwide emphasize cost-effective conservative interventions before surgical options, companies developing orthopedic devices face increasing pressure to demonstrate clinical efficacy through rigorous trials. For investors and industry stakeholders, studies like this provide crucial validation points for innovative approaches in the growing foot orthoses market, particularly those leveraging advanced manufacturing techniques.

Summary

A randomized controlled trial set to begin in January 2026 will evaluate the effectiveness of customized foot orthoses with metatarsal pads for treating chronic metatarsalgia, a condition affecting up to 36% of adults and representing 88% of foot pain causes. Researchers from Université du Québec à Trois-Rivières will conduct the participant- and assessor-blinded superiority trial involving 64 participants over 12 weeks, comparing 3D-printed customized orthoses featuring a 6° medial wedge against sham devices. The study addresses a significant evidence gap in conservative treatment options for this prevalent condition. Primary outcomes will measure pain reduction during walking using a visual analog scale, with secondary measures including foot function, quality of life, and plantar pressure assessments. The trial employs sophisticated minimization randomization methods and linear mixed-effects models for statistical analysis. A distinctive feature is the use of 3D printing technology to create personalized orthoses with Nylon shells and strategically positioned metatarsal pads, representing the intersection of digital manufacturing and personalized medicine. Results expected by August 2027 will provide high-level evidence for clinical practice and have significant implications for the orthopedic device market, particularly as healthcare systems increasingly emphasize cost-effective conservative interventions before surgical options.