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Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis

Primary Purpose

Fasciitis, Plantar

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Karaoke Exercise
Balance walking exercise
Forefoot extension exercise
Standing one-legged balance exercise:
Ankle inversion/eversion exercise
Gastrocnemius and soleus stretching
Tissue-specific plantar fascia self massage
Dexamethasone
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fasciitis, Plantar focused on measuring Chronic plantar fasciitis, Workplace injury, Foot and Ankle Disability Index, Ultrasound measure of disease severity

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of British Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

Standard of Care

Arm Description

Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.

This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 14, 2011
Last Updated
March 20, 2013
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01297686
Brief Title
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

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciitis, Plantar
Keywords
Chronic plantar fasciitis, Workplace injury, Foot and Ankle Disability Index, Ultrasound measure of disease severity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf.
Intervention Type
Other
Intervention Name(s)
Karaoke Exercise
Intervention Description
lateral side step movement involving crossing one foot over the next for 5 sets of 15 cross-overs in each direction
Intervention Type
Other
Intervention Name(s)
Balance walking exercise
Intervention Description
Walking along a straight line on the ground, for 5 sets of 30 strides
Intervention Type
Other
Intervention Name(s)
Forefoot extension exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standing one-legged balance exercise:
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ankle inversion/eversion exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gastrocnemius and soleus stretching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Tissue-specific plantar fascia self massage
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline in Foot and Ankle Disability Index (FADI) at 6 weeks
Description
Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle.
Time Frame
6 weeks
Title
Change from Baseline in Foot and Ankle Disability Index (FADI) at 12 weeks
Description
Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Ultrasound-Based Grading of Pathology at 12 weeks
Description
A 3-level ordinal scale assessing a composite of hypoechogenicity and neovascularity will be documented.
Time Frame
12 weeks
Title
Change in Acoustoelastographic Analysis of Plantar Fascia Elasticity at 12 Weeks
Description
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.
Time Frame
12 weeks
Title
Change in Visual Analog Scale for Pain at 12 weeks
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Taunton, Dr.
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1T3
Country
Canada

12. IPD Sharing Statement

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Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis

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