Fasciitis, PlantarPhase 2/3NCT01297686
Exercise Versus Corticosteroid Randomized Clinical Trial for Plantar Fasciitis
A Phase 2/3 study testing Karaoke Exercise, Balance walking exercise and Forefoot extension exercise in people with Fasciitis, Plantar, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- Karaoke Exercise, Balance walking exercise and Forefoot extension exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Apr 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of British Columbia
Vancouver, British Columbia, V6Z 1T3
About this study
Official title: 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.
- Conditions
- Fasciitis, Plantar
- Being tested
- Karaoke Exercise, Balance walking exercise, Forefoot extension exercise, Standing one-legged balance exercise:, Ankle inversion/eversion exercise
- Keywords
- Chronic plantar fasciitis, Workplace injury, Foot and Ankle Disability Index, Ultrasound measure of disease severity
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Karaoke ExerciseOther
lateral side step movement involving crossing one foot over the next for 5 sets of 15 cross-overs in each direction
Balance walking exerciseOther
Walking along a straight line on the ground, for 5 sets of 30 strides
Forefoot extension exerciseOther
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: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 exerciseOther
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 stretchingOther
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 massageOther
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.
DexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Multi-element exercise protocol involving static and dynamic stretches, deep massage, and balance training. Receives: 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 |
| Standard of Care | Active comparator | This arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf. Receives: Other: Gastrocnemius and soleus stretching; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack Taunton, Dr., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297686
- Sponsor's protocol ID
- H10-03368
- Other IDs
- RS2010-IG20
- Status last verified
- Mar 2013
- First submitted
- 14 Feb 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial of a Multi-Element Exercise Program for Plantar Fasciopathy in Workers Required to Stand for Prolonged Periods of Time
- ClinicalTrials.gov ID
- NCT01297686
- Acronym / sponsor ID
- H10-03368
- Conditions
- Fasciitis, Plantar
- Keywords
- Chronic plantar fasciitis, Workplace injury, Foot and Ankle Disability Index, Ultrasound measure of disease severity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | 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 massageMulti-element exercise protocol involving static and dynamic stretches, deep massage, and balance training. |
| Standard of Care | Active comparator | Other: Gastrocnemius and soleus stretching, Drug: DexamethasoneThis arm will consist of a single injection of a corticosteroid, followed by stretching exercises for the calf. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Karaoke Exerciselateral side step movement involving crossing one foot over the next for 5 sets of 15 cross-overs in each direction | Other | Exercise |
| Balance walking exerciseWalking along a straight line on the ground, for 5 sets of 30 strides | Other | Exercise |
| Forefoot extension exerciseThe 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 | Exercise |
| 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 | Exercise |
| Ankle inversion/eversion exerciseThe 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 | Exercise |
| Gastrocnemius and soleus stretchingThis 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 | Exercise, Standard of Care |
| Tissue-specific plantar fascia self massageThis 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. | Other | Exercise |
| DexamethasoneA 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. | Drug | Standard of Care |
Primary outcome
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.
3 secondary outcomes
Change in Ultrasound-Based Grading of Pathology at 12 weeks
Time frame: 12 weeks
Change in Acoustoelastographic Analysis of Plantar Fascia Elasticity at 12 Weeks
Time frame: 12 weeks
Change in Visual Analog Scale for Pain at 12 weeks
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack Taunton, Dr. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Karaoke Exercise, Balance walking exercise and Forefoot extension exercise in people with Fasciitis, Plantar, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Foot and Ankle Disability Index (FADI) at 6 weeks (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.