Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis

NCT ID: NCT01297686

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-04-30

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.

Conditions

Fasciitis, Plantar

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise

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

Group Type: EXPERIMENTAL

Karaoke Exercise

Intervention Type: OTHER

lateral side step movement involving crossing one foot over the next for 5 sets of 15 cross-overs in each direction

Balance walking exercise

Intervention Type: OTHER

Walking along a straight line on the ground, for 5 sets of 30 strides

Forefoot extension exercise

Intervention Type: OTHER

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.

Standing one-legged balance exercise:

Intervention Type: OTHER

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.

Ankle inversion/eversion exercise

Intervention Type: OTHER

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.

Gastrocnemius and soleus stretching

Intervention Type: OTHER

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.

Tissue-specific plantar fascia self massage

Intervention Type: OTHER

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.

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Gastrocnemius and soleus stretching

Intervention Type: OTHER

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.

Dexamethasone

Intervention Type: DRUG

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.

Interventions

Karaoke Exercise

lateral side step movement involving crossing one foot over the next for 5 sets of 15 cross-overs in each direction

Intervention Type: OTHER

Balance walking exercise

Walking along a straight line on the ground, for 5 sets of 30 strides

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jack Taunton, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

RS2010-IG20

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H10-03368

Identifier Type: -

Identifier Source: org_study_id