Clinical trial NCT01297686: Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis
Official title: A Clinical Trial of a Multi-Element Exercise Program for Plantar Fasciopathy in Workers Required to Stand for Prolonged Periods of Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Fasciitis, Plantar
Keywords: Chronic plantar fasciitis
Workplace injury
Foot and Ankle Disability Index
Ultrasound measure of disease severity
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2011-02-17
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adult workers (men and women) between the ages of 19 and 60
* Workers required to stand for 6 hours or more in their respective workplaces
* Diagnosed with plantar fasciopathy (plantar fasciitis). All diagnoses will be made by a physiotherapist based on the presentation of palpable pain at or around the plantar medial heel, in addition to pain during weight-bearing activities and the presence of morning pain.
* Only individuals with pain for longer than 12 months will be included.

Exclusion Criteria:

* A history of surgery to their plantar fascia
* Osteoarthritis or other degenerative musculoskeletal disorders affecting the lower extremity
* Individuals who have received corticosteroid injections into their affected plantar fascia at any time in the past will be excluded.

Primary outcomes:
measure: Change from Baseline in Foot and Ankle Disability Index (FADI) at 6 weeks
timeFrame: 6 weeks
measure: Change from Baseline in Foot and Ankle Disability Index (FADI) at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Ultrasound-Based Grading of Pathology at 12 weeks
timeFrame: 12 weeks
measure: Change in Acoustoelastographic Analysis of Plantar Fascia Elasticity at 12 Weeks
timeFrame: 12 weeks
measure: Change in Visual Analog Scale for Pain at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jack Taunton, Dr.
role: PRINCIPAL_INVESTIGATOR
References: