Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis

Phase 2

Completed

• Conditions: Fasciitis, Plantar
• Interventions: Other: Karaoke Exercise; Other: Balance walking exercise; Drug: Dexamethasone; Other: Forefoot extension exercise; Other: Ankle inversion/eversion exercise; Other: Gastrocnemius and soleus stretching; Other: Tissue-specific plantar fascia self massage

• Registration Number: NCT01297686
• Lead Sponsor: University of British Columbia

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 Description

Not available

Study Timeline

• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-17
• Study Start: 2011-05
• Primary Completion: 2012-02
• Study Completion: 2012-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-20
• Last Update Posted: 2013-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Karaoke Exercise	Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
Exercise	Balance walking exercise	Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
Exercise	Forefoot extension exercise	Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
Exercise	Ankle inversion/eversion exercise	Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
Exercise	Gastrocnemius and soleus stretching	Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
Exercise	Tissue-specific plantar fascia self massage	Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
Standard of Care	Gastrocnemius and soleus stretching	This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf.
Standard of Care	Dexamethasone	This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Ultrasound-Based Grading of Pathology at 12 weeks	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	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	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.

Trial Locations

Locations (1)

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada