Hallux Limitus Treated With Dynamic Splinting: A Randomized, Controlled Trial

Dynasplint Systems, Inc.50 enrolled

Overview

The purpose of this study is to regain range of motion of the great toe with dynamic splinting which will help reduce great toe's pain and swelling.

Determine the efficacy of dynamic splinting in treating patients with hallux limitus, in a randomized, controlled trial.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hallux Limitus

Interventions

Metatarsophalangeal Extension Dynasplint SystemDEVICE

Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn for 30 minutes, three times per day, (while seated or resting in bed) totaling 1.5 hours per day.

Standard of CareOTHER

The current standard of care in treating Hallux Limitus will be given to all patients regardless of randomized categorization, and this includes: analgesic and nonsteroidal anti-inflammatory drugs (NSAIDs), orthotics with medial stiffness, and reduction of great toe movement in motions such as kneeling or squatting with the toes in an extended position.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Reduced flexibility in AROM of extension in the great toe * Pain that is worsened by walking and/or squatting * Impaired gait pattern Exclusion Criteria: * Metatarsal stress fracture * Interdigital neuroma * Sesamoid pathology * Gout * Metatarsalgia

Locations (2)

Atlanta Foot and Leg Clinic

Jonesboro, Georgia, United States

Ankle and Foot Centers, PC

Marietta, Georgia, United States

Outcomes

Primary Outcomes

Change in Active Range of Motion of Hallux (great toe) Extension

Time frame: Two Months

Secondary Outcomes

Change in passive Range of Motion, Extension

Time frame: same

Data from ClinicalTrials.gov

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