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Completed

NCT Number: NCT00717691

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

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.

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Key information

Conditions

Hallux Limitus Foot Deformities Foot Deformities, Acquired Foot Injuries Joint Diseases Leg Injuries Musculoskeletal Diseases Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Foot and Leg Clinic, Jonesboro, Georgia, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Metatarsophalangeal Extension Dynasplint System

Device

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 care

Other

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.

Primary outcomes

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

    Time frame: Two Months

Secondary outcomes

  1. Change in passive Range of Motion, Extension

    Time frame: same

Sponsors and collaborators

Lead sponsor

Dynasplint Systems, Inc.

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 17, 2008
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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