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Completed

NCT Number: NCT01334346

Footwear Minimalism Study

The following study proposes to investigate the injury risk associated with the use of a new category of running footwear: the minimalist shoe. A group of experienced adult male and female runners with neutral foot types will take part in this study. All participants will be randomized to receive one of three different shoes: a full minimalist shoe (Vibram 5-Fingers), a partial minimalist shoe (Nike Free 3.0) and a conventional neutral supportive running shoe (Nike Pegasus), while training for a 10k event over a 14-week period. Outcomes to be investigated are pain, footwear perception, and number of injury events.

The hypothesizes is that participants using the minimalist footwear during their running program will experience a reduction in running related pain. A greater degree of footwear minimalism will result in a greater reduction in pain (compared to the partial minimalist shoe, Nike Free).

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Key information

Conditions

Healthy Runners Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Minimum of 5 years experience running
  • Have been running on a regular basis (minimum once per week) over the past 6 months
  • Able to run for 60 minutes continuously
  • Can tolerate 20-40km per week in training
  • Neutral foot posture according to the Foot Posture Index.

Exclusion criteria

  • Have not experienced a running related injury requiring a stoppage of 2-weeks or more in the past 6 months
  • History of surgery to their plantar fascia or Achilles tendon
  • Have already been running in a minimalist shoe
  • Have a diagnosis of osteoarthritis - or other degenerative musculoskeletal disorder - affecting the lower extremity
  • Are currently taking analgesic medication.

Treatment and study plan

Nike Pegasus

Other

Conventional neutral supportive running footwear. Non minimalist.

Nike Free 3.0

Other

Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.

Vibram Five Fingers Shoe

Other

Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.

Primary outcomes

  1. Number of Injury Events

    Time frame: 12 weeks

    Number of run injury events (defined as unable to complete 3 consecutive running workouts due to running related pain). A calculation of injury incidence will be based on this number after dividing by the number of athletic exposures.

Secondary outcomes

  1. Foot and Ankle Disability Index (FADI)

    Time frame: Week 12

  2. Numerical Pain Scale (NPS) for Overall Running Related Pain

    Time frame: Week 12

  3. Regional Specific NPS: Shin and Calf Pain

    Time frame: Week 12

  4. Regional Specific NPS: Foot and Ankle Pain

    Time frame: 12 Week

  5. Regional Specific NPS: Knee Pain

    Time frame: 12 Weeks

  6. Regional Specific NPS: Pelvis and Groin Pain

    Time frame: 12 Week

  7. Regional Specific NPS: Lower Back Pain

    Time frame: 12 Week

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • Nike

Registry information

Official study title

An Investigation on Footwear Minimalism and Injury Risk in Runners

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Apr 13, 2011
Registry last updated
Mar 29, 2013

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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