Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis

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

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.

Study Overview

• Status: Completed
• Conditions: Fasciitis, Plantar
• Intervention / Treatment: Other: Karaoke Exercise; Other: Balance walking exercise; Other: Forefoot extension exercise; Other: Standing one-legged balance exercise:; Other: Ankle inversion/eversion exercise; Other: Gastrocnemius and soleus stretching; Other: Tissue-specific plantar fascia self massage; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1T3
      • University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Exercise; Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.	Other: Karaoke Exercise; lateral side step movement involving crossing one foot over the next for 5 sets of 15 cross-overs in each direction; Other: Balance walking exercise; Walking along a straight line on the ground, for 5 sets of 30 strides; Other: Forefoot extension exercise; The subject stands feet shoulder width apart with one foot ahead of the other and then contracting only calf muscles of the back leg, lifts the heel of the back leg until the metatarsophalangeal joint of that foot is maximally extended. The subject is instructed to concentrate on maintaining balance on the back leg over the first and second metatarsophalangeal joints throughout movement for 5 sets of 15 repetitions.; Other: Standing one-legged balance exercise: This exercise is performed initially with eyes open, then with mastery exhibited by being able to hold balance and not touch the ground with contralateral leg performed with eyes closed, then on an unstable surface with and without eyes open for 1 minute.; Other: Ankle inversion/eversion exercise; The foot is placed sideways at the edge of a step. After stabilizing the remainder of the foot and leg, the ankle is inverted and everted to the limits of the range for 3 sets of 15 repetitions.; Other: Gastrocnemius and soleus stretching; This stretch is performed while standing in a neutral position and the knee extended the foot is placed on top of a ramp or phone-book elevating the forefoot on the rearfoot (talocrural dorsiflexion) and held for 3 sets of 30 seconds each. Next the foot is again placed on top of a phone-book with the knee flexed approximately 15-20 degrees and held for 3 sets of 30 seconds each.; Other: Tissue-specific plantar fascia self massage; This deep massage is performed in a sitting position the right foot is crossed over the left while one hand passively extends the right forefoot. The left hand then applies light to moderate pressure in 3-5 second intervals along the length of the medial longitudinal arch. Same procedure is then repeated for the left foot.
Active Comparator: Standard of Care; This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf.	Other: Gastrocnemius and soleus stretching; This stretch is performed while standing in a neutral position and the knee extended the foot is placed on top of a ramp or phone-book elevating the forefoot on the rearfoot (talocrural dorsiflexion) and held for 3 sets of 30 seconds each. Next the foot is again placed on top of a phone-book with the knee flexed approximately 15-20 degrees and held for 3 sets of 30 seconds each.; Drug: Dexamethasone; A 22-gauge, 1.5" needle and 3 cm syringe filled with 1ml of dexamethasone mixed with 0.5ml of 1% lidocaine. Prior to injection, the skin will be sterilized with povidone-iodine. The needle is inserted 2-3 cm anteromedial to the focal point of pain in the inferior heel near the calcaneal tuberosity and moved toward the tenderest area.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Ultrasound-Based Grading of Pathology at 12 weeks	A 3-level ordinal scale assessing a composite of hypoechogenicity and neovascularity will be documented.	12 weeks
Change in Acoustoelastographic Analysis of Plantar Fascia Elasticity at 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.	12 weeks
Change in Visual Analog Scale for Pain at 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.	12 weeks

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Jack Taunton, Dr., University of British Columbia

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (Estimate): February 17, 2011

Study Record Updates

• Last Update Posted (Estimate): March 22, 2013
• Last Update Submitted That Met QC Criteria: March 20, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: Chronic plantar fasciitis; Workplace injury; Foot and Ankle Disability Index; Ultrasound measure of disease severity
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: H10-03368; RS2010-IG20 (Other Grant/Funding Number: WorkSafeBC)