The Effect of a Discharge Sock Model in Comfort: Randomized Controlled Trial
Condition: Foot Diseases; Metatarsalgia; Pain
MeSH terms: Foot Diseases; Metatarsalgia
Study type: Interventional

Summary: 
      Metatarsalgia is a common set of symptoms in the forefoot, characterized by pain under one or
      more metatarsal heads. The invention of a utility model, the U202030700, designed by the
      study's principal investigator aims to protect the metatarsus and prevent the appearance of
      foot pain.

      The hypothesis of this research project is based on the fact that using our proposed sock
      with metatarsal discharge plate will bring advantages in terms of pain reduction, increased
      comfort, temperature reduction and change in plantar pressures received in the second and
      third metatarsals joint area versus the use of control socks (without discharge plate).

      Participants will be subjects with pain in the plantar metatarsal area that will answer few
      questions and a podiatric exam to determine if meet the study requirements and then a plantar
      pressures, foot temperature and confort wit the two kind of socks will be taken.

      Confort survey, thermal pictures and plantar pressures will be taken (in first term) before
      and after a brief walk (5 to 10 minutes) and in a second experiment (second term) after a
      long walk (more than 1 hour).
    

Detailed description: 
      Metatarsalgia is a common set of symptoms in the forefoot, characterized by pain under one or
      more metatarsal heads. First option should opt for conservative treatments, among these it is
      noteworthy the application of pressure relief elements from these anatomical zones. These
      elements, usually made of soft materials such as felt or foams of different compositions, are
      arranged covering the entire metatarsal area, with the exception of the compromised sector,
      that is, overloaded and painful, giving rise to discharge elements with a geometry similar to
      a U. In this way, the other areas of the metatarsus support the discharge element leaving
      exposed the overloaded area, so that it reduces or avoids its direct support on the support
      surface, thus mitigating the excess pressure in the compromised area and therefore, pain.. It
      is therefore desirable to have unloading elements of the metatarsal area, easy to use by a
      user and that do not involve major alterations in their usual clothing.

      Different types of socks are known with configurations which give them beneficial effects on
      health. However, these existing models have not specifically focused on the plantar part of
      the sock, there is therefore no simple and economical solution for the protection of the
      metatarsus and the mitigation of pain and discomfort usually caused by its pathologies. This
      has been solved by the invention of a utility model, the U202030700, designed by the study's
      principal investigator and his research group.

      The hypothesis of this research project is based on the fact that using our proposed sock
      with metatarsal discharge plate will bring advantages in terms of pain reduction, increased
      comfort, temperature reduction and change in plantar pressures received in the second and
      third metatarsals joint area versus the use of control socks (without discharge plate).

      Specific objectives:

      - To record the differences of plantar pressures, thermal and general confort with control
      socks and experimental socks after a briefs walks.

      The type of intervention will be randomly assigned, meaning neither participant nor the
      secondary researchers knows the sock worn. The principal investigator (Alfonso Martínez Nova)
      will perform the randomization.

      Participants. Subjects with pain in the plantar metatarsal area are suitable to participate
      in the study.

      Participants will answer few questions and a podiatric exam to determine if meet the study
      requirements and then:

      Answering a survey on health status and pain in the metatarsal area mainly. Collection of the
      necessary data (plantar pressures, foot temperature and confort wit the two kind of socks.

      Materials: Experiment socks and control (same fiber, fabric, weight). Pressure platform
      Footscan. Flir e60bx thermographic camera.

      Confort survey, thermal pictures and plantar pressures will be taken (in first term) before
      and after a brief walk (5 to 10 minutes) and in second term, before and after a long walk
      (more than 1 hour).

      The new sock aimed to protect the metatarsus and prevent the appearance of foot pain.
    

Intervention name(s): Plantar pressures will be measured in 7 zones using the Footscan® platform following the two-step method. Three plantar pressures measurements were made for each foot.
Intervention type(s): Diagnostic Test
Intervention description(s): to protect the metatarsus and prevent the appearance of foot pain.
Other intervention name(s): Thermal picture. An infrared camera (Flir e60bx) will measure skin temperature. This study mapped out five subregions of anatomic interest over the foot.; Confort survey. An standardized confort survey about different issues of the socks will be fulfilled before and after walking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: foot; metatarsalgia; pain; pressure relief; socks; confort