Clinical Trial: Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Trial of a Multi-Element Exercise Program for Plantar Fasciopathy in Workers Required to Stand for Prolonged Periods of Time

Brief Summary: Chronic plantar fasciopathy is a painful condition common in the workplace, particularly for those workers required to stand for long periods of time, and is typically associated with point tenderness at heel and arch of the foot. This clinical trial will investigate the effectiveness of an innovative multi-element exercise program versus the standard of care for plantar fasciopathy. The observation period will be 12-weeks. Outcomes are determined through questionnaire and ultrasound imaging. Workers with long-standing plantar fasciopathy who must stand for prolonged periods of time (i.e. > 6 hours) during their workday will be invited to participate in this study. After ensuring eligibility, each subject will be randomly assigned to either the intervention group who will receive a multi-element exercise program, or the control group who will receive a cortisone injection followed by a stretching program for their calf-muscles (standard of care). The treatment length for both groups will be 12-weeks.

Detailed Summary:
Sponsor: University of British Columbia

Current Primary Outcome:

  • Change from Baseline in Foot and Ankle Disability Index (FADI) at 6 weeks [ Time Frame: 6 weeks ]
    Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle.
  • Change from Baseline in Foot and Ankle Disability Index (FADI) at 12 weeks [ Time Frame: 12 weeks ]
    Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in Ultrasound-Based Grading of Pathology at 12 weeks [ Time Frame: 12 weeks ]
    A 3-level ordinal scale assessing a composite of hypoechogenicity and neovascularity will be documented.
  • Change in Acoustoelastographic Analysis of Plantar Fascia Elasticity at 12 Weeks [ Time Frame: 12 weeks ]
    A novel method of calculating the mechanical properties of deformation dependent soft-tissue using only ultrasound cine-images. Specific outcomes will include plantar fascial stiffness, strain, and modulus of elasticity.
  • Change in Visual Analog Scale for Pain at 12 weeks [ Time Frame: 12 weeks ]
    Participants mark on a 100mm line the amount of pain on average they have experienced over the past 7 days. Items for both pain at work and pain with activities of daily living are included.


Original Secondary Outcome: Same as current

Information By: University of British Columbia

Dates:
Date Received: February 14, 2011
Date Started: May 2011
Date Completion:
Last Updated: March 20, 2013
Last Verified: March 2013