Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis
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|ClinicalTrials.gov Identifier: NCT01297686|
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : March 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Fasciitis, Plantar||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||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||May 2011|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||April 2012|
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 directionOther: Balance walking exercise
Walking along a straight line on the ground, for 5 sets of 30 stridesOther: 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297686
|Canada, British Columbia|
|University of British Columbia|
|Vancouver, British Columbia, Canada, V6Z 1T3|
|Principal Investigator:||Jack Taunton, Dr.||University of British Columbia|