Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01297686
First received: February 14, 2011
Last updated: March 20, 2013
Last verified: March 2013

February 14, 2011
March 20, 2013
May 2011
February 2012   (final data collection date for primary outcome measure)
  • Change from Baseline in Foot and Ankle Disability Index (FADI) at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patient-centered health-realted quality of life indicator measuriing disability at the foot and ankle.
Same as current
Complete list of historical versions of study NCT01297686 on ClinicalTrials.gov Archive Site
  • Change in Ultrasound-Based Grading of Pathology at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Fasciitis, Plantar
  • 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.
  • 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.
  • Experimental: Exercise
    Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training.
    Interventions:
    • 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
  • Active Comparator: Standard of Care
    This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf.
    Interventions:
    • Other: Gastrocnemius and soleus stretching
    • Drug: Dexamethasone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
April 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01297686
H10-03368, RS2010-IG20
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Jack Taunton, Dr. University of British Columbia
University of British Columbia
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP