Plantar FasciitisNCT02196155
Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis
A study testing Botulinum toxin A, cortisone and Saline in people with Plantar Fasciitis, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Botulinum toxin A, cortisone and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jul 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical symptoms of a plantar fasciitis
- Plantar fasciitis in MRI
Who cannot join
- Symptoms more than 3 months
- Absolution of 3 months unsuccessful treatment
- Written informed consent
- Active differential diagnoses
- Contraindications: pregnancy and breastfeeding, infection at injection sites, allergy against BTX-A
- Previous injections or surgery for plantar fasciitis
- Neurological diseases affecting the peripheral nervous system
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Dep, of Orthopaedic Surgery, Inselspital, University of Berne
Bern, 3010
Fabian Krause, PD Dr., 0041316322220, fabian.krause@insel.ch
Fabian Krause, PD Dr.
- Recruiting
Department of Orthopaedic Surgery, Kantonsspital Lucerne
Lucerne, 6000
Lukas Iselin, Dr., 004141 205 4807, lukas.iselin@luks.ch
Lukas Iselin, Dr.
About this study
Official title: Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis: a Randomized Controlled Study
Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics.
Nonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best.
Read more
The investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).
However, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed.
Read the detailed description
Background
Plantar fasciitis is the classic and most common type of heel pain. Extrapolating the rate of 2 million or 0.6% of the US American population being treated for plantar fasciitis every year to Switzerland, the corresponding number of patients would amount to 50'000 patients being treated for plantar fasciitis. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics.
Nonoperative treatment is the mainstay of treating plantar fasciitis. In the literature, numerous operative and nonoperative treatment approaches for plantar fasciitis have been suggested. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best. Numerous prescriptions for unnecessary orthoses, expensive and painful shock waves, and complications following steroid injection could be obviated, when the safe BTX-A injection demonstrates good results.
The investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).
The high number of level I and II studies suggests that there is need for clarification and evaluation of the efficacy of several non-operative and operative treatment approaches for the chronic plantar fasciitis. However, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed. Objective evaluation of the BTX-A efficacy includes the randomized allocation of patients to the BTX-A, the steroid, or the saline group, the blinded comparison to the sham (saline) injection, and finally the MRI assessment at the beginning and at the end of the followup. With the evidence resulting from this study, patients can be superiorly counseled in the future with regard to efficacy of nonoperative treatment of plantar fasciitis.
Objective
Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best.
Methods
Patients are randomly allocated to three groups (1 - 3).
- Patient group 1 - combination of physiotherapy, stretching exercises according to DiGiovanni et al and BTX-A injection into the gastroc-soleus complex: One hundred units (U) of toxin are applied to each muscle belly, and 1 application of 50 U is administered to the soleus, making a total of 250 U.
- Patient group 2 - physiotherapy, stretching exercises according to DiGiovanni combined with cortisone injection into the plantar fascia
- Patient group 3 - physiotherapy, stretching exercises according to DiGiovanni and saline injection into the gastroc-soleus complex (sham control group)
- Conditions
- Plantar Fasciitis
- Being tested
- Botulinum toxin A, cortisone, Saline
- Keywords
- plantar fasciitis, Botulinum toxin A, Cortisone, RCT
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin ADrug
Researchers discovered in the 1950s that injecting overactive muscles with minute quantities of botulinum toxin type-A would result in decreased muscle activity. Botulinum toxin type-A has this effect because it prevents the vesicle where the acetylcholine is stored from binding to the membrane where the neurotransmitter can be released. Botulinum toxin type-A thus blocks the release of acetylcholine by the neuron. This will effectively weaken the muscle for a period of three to four months.
In addition to its cosmetic applications, Botox is currently used in the treatment of spasms and dystonias, by weakening involved muscles, for the 60-70 day effective period of the drug. The main conditions treated with botulinum toxin are: Cervical dystonia (spasmodic torticollis) (a neuromuscular disorder involving the head and neck), Blepharospasm (excessive blinking) etc..
cortisoneDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| BTX-A | Active comparator | Botulinum A toxin is injected each 100 U in both gastrocnemius muscle-bellies and 50 U in the soleus muscle, i.e. a total of 250 U. Receives: Drug: Botulinum toxin A |
| Cortisone | Active comparator | Depot Medrol is injected at the plantar fascia insertion site at the calcaneus Receives: Drug: cortisone |
| Saline | Placebo comparator | Placebo saline is injected in both gastrocnemius muscle-bellies and in the soleus muscle Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in foot pain
Measured by VAS FA subjective foot score
Measured: at 6 weeks, 3, 6 and 12 (24) months
Secondary outcomes (6)
Change from baseline in patient health
Measured by SF 36
Measured: at 6 weeks, 3, 6 and 12 (24) months
Change from baseline in pain, disability and activity restriction in foot
Measured by foot functional index FFI
Measured: at 6 weeks, 3, 6 and 12 (24) months
General pain
Measured by VAS pain scale
Measured: at 6 weeks, 3, 6 and 12 (24) months
Reduction of inflammation
Measured by MRI
Measured: pre-intervention and at 12 months
Number of patients with complications
Measured: at 6 weeks, 3, 6 and 12 (24) months
Change from baseline in ankle range of motion
Measured by goniometer
Measured: at 6 weeks, 3, 6 and 12 (24) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJul 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Luzerner Kantonsspital
- Responsible party
- Sponsor
- Investigators
- Fabian Krause, PD Dr., Principal investigator, Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02196155
- Sponsor's protocol ID
- 32003B_152671
- Status last verified
- Dec 2024
- First submitted
- 17 Jul 2014
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brin MF, Lew MF, Adler CH, Comella CL, Factor SA, Jankovic J, O'Brien C, Murray JJ, Wallace JD, Willmer-Hulme A, Koller M. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999 Oct 22;53(7):1431-8. doi: 10.1212/wnl.53.7.1431.
PubMed 10534247Bihari K. Safety, effectiveness, and duration of effect of BOTOX after switching from Dysport for blepharospasm, cervical dystonia, and hemifacial spasm dystonia, and hemifacial spasm. Curr Med Res Opin. 2005 Mar;21(3):433-8. doi: 10.1185/030079905X36396.
PubMed 15811212Elizondo-Rodriguez J, Araujo-Lopez Y, Moreno-Gonzalez JA, Cardenas-Estrada E, Mendoza-Lemus O, Acosta-Olivo C. A comparison of botulinum toxin a and intralesional steroids for the treatment of plantar fasciitis: a randomized, double-blinded study. Foot Ankle Int. 2013 Jan;34(1):8-14. doi: 10.1177/1071100712460215.
PubMed 23386757
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botulinum Toxin A Versus Steroids for the Treatment of Chronic Plantar Fasciitis: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02196155
- Acronym / sponsor ID
- 32003B_152671
- Conditions
- Plantar Fasciitis
- Keywords
- plantar fasciitis, Botulinum toxin A, Cortisone, RCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Luzerner Kantonsspital
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Jul 2014 (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.
Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics.
Nonoperative treatment is the mainstay of treating plantar fasciitis. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best.
The investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).
However, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed.
Detailed description
Background
Plantar fasciitis is the classic and most common type of heel pain. Extrapolating the rate of 2 million or 0.6% of the US American population being treated for plantar fasciitis every year to Switzerland, the corresponding number of patients would amount to 50'000 patients being treated for plantar fasciitis. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics.
Nonoperative treatment is the mainstay of treating plantar fasciitis. In the literature, numerous operative and nonoperative treatment approaches for plantar fasciitis have been suggested. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best. Numerous prescriptions for unnecessary orthoses, expensive and painful shock waves, and complications following steroid injection could be obviated, when the safe BTX-A injection demonstrates good results.
The investigators believe that the BTX-A injection in the gastrocnemius and the soleus muscles is currently the most promising non-operative approach, because it is considered to treat the disease at its origin (temporary weakening of the tight triceps surae muscle) as opposed to simply alleviate the symptoms (e.g. plantar cortisone and other injections, ESWT).
The high number of level I and II studies suggests that there is need for clarification and evaluation of the efficacy of several non-operative and operative treatment approaches for the chronic plantar fasciitis. However, to date there is no evidence in the literature that compares the new, promising technique of BTX-A injection into the gastroc-soleus complex to a sham (saline) injection and to the gold standard steroid injection at the plantar fascia insertion site. With the intended study, this gap is going to be closed. Objective evaluation of the BTX-A efficacy includes the randomized allocation of patients to the BTX-A, the steroid, or the saline group, the blinded comparison to the sham (saline) injection, and finally the MRI assessment at the beginning and at the end of the followup. With the evidence resulting from this study, patients can be superiorly counseled in the future with regard to efficacy of nonoperative treatment of plantar fasciitis.
Objective
Plantar fasciitis is the classic and most common type of heel pain. Considering the costs for health care and the temporary disability not only for work, plantar fasciitis results in a substantial (and at least partially unnecessary) burden for the Swiss health care system and national economics. However, so far no treatment has proven to be superior to others, and there is national and international lack of consensus of how to treat plantar fasciitis best.
Methods
Patients are randomly allocated to three groups (1 - 3).
- Patient group 1 - combination of physiotherapy, stretching exercises according to DiGiovanni et al and BTX-A injection into the gastroc-soleus complex: One hundred units (U) of toxin are applied to each muscle belly, and 1 application of 50 U is administered to the soleus, making a total of 250 U.
- Patient group 2 - physiotherapy, stretching exercises according to DiGiovanni combined with cortisone injection into the plantar fascia
- Patient group 3 - physiotherapy, stretching exercises according to DiGiovanni and saline injection into the gastroc-soleus complex (sham control group)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BTX-A | Active comparator | Drug: Botulinum toxin ABotulinum A toxin is injected each 100 U in both gastrocnemius muscle-bellies and 50 U in the soleus muscle, i.e. a total of 250 U. |
| Cortisone | Active comparator | Drug: cortisoneDepot Medrol is injected at the plantar fascia insertion site at the calcaneus |
| Saline | Placebo comparator | Drug: SalinePlacebo saline is injected in both gastrocnemius muscle-bellies and in the soleus muscle |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical symptoms of a plantar fasciitis
- Plantar fasciitis in MRI
Key exclusion criteria (7 listed)
- Symptoms more than 3 months
- Absolution of 3 months unsuccessful treatment
- Written informed consent
- Active differential diagnoses
- Contraindications: pregnancy and breastfeeding, infection at injection sites, allergy against BTX-A
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 |
|---|---|---|
| Botulinum toxin AResearchers discovered in the 1950s that injecting overactive muscles with minute quantities of botulinum toxin type-A would result in decreased muscle activity. Botulinum toxin type-A has this effect because it prevents the vesicle where the acetylcholine is stored from binding to the membrane where the neurotransmitter can be released. Botulinum toxin type-A thus blocks the release of acetylcholine by the neuron. This will effectively weaken the muscle for a period of three to four months. In addition to its cosmetic applications, Botox is currently used in the treatment of spasms and dystonias, by weakening involved muscles, for the 60-70 day effective period of the drug. The main conditions treated with botulinum toxin are: Cervical dystonia (spasmodic torticollis) (a neuromuscular disorder involving the head and neck), Blepharospasm (excessive blinking) etc.. | Drug | BTX-A |
| cortisone | Drug | Cortisone |
| Saline | Drug | Saline |
Primary outcome
Change from baseline in foot pain
Time frame: at 6 weeks, 3, 6 and 12 (24) months
Measured by VAS FA subjective foot score
6 secondary outcomes
Change from baseline in patient health
Time frame: at 6 weeks, 3, 6 and 12 (24) months
Change from baseline in pain, disability and activity restriction in foot
Time frame: at 6 weeks, 3, 6 and 12 (24) months
General pain
Time frame: at 6 weeks, 3, 6 and 12 (24) months
Reduction of inflammation
Time frame: pre-intervention and at 12 months
Number of patients with complications
Time frame: at 6 weeks, 3, 6 and 12 (24) months
Change from baseline in ankle range of motion
Time frame: at 6 weeks, 3, 6 and 12 (24) months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Results publication: PubMed 10534247Brin MF, Lew MF, Adler CH, Comella CL, Factor SA, Jankovic J, O'Brien C, Murray JJ, Wallace JD, Willmer-Hulme A, Koller M. Safety and efficacy of NeuroBloc (botulinum toxin type B) in type A-resistant cervical dystonia. Neurology. 1999 Oct 22;53(7):1431-8. doi: 10.1212/wnl.53.7.1431.
- Results publication: PubMed 15811212Bihari K. Safety, effectiveness, and duration of effect of BOTOX after switching from Dysport for blepharospasm, cervical dystonia, and hemifacial spasm dystonia, and hemifacial spasm. Curr Med Res Opin. 2005 Mar;21(3):433-8. doi: 10.1185/030079905X36396.
- Results publication: PubMed 23386757Elizondo-Rodriguez J, Araujo-Lopez Y, Moreno-Gonzalez JA, Cardenas-Estrada E, Mendoza-Lemus O, Acosta-Olivo C. A comparison of botulinum toxin a and intralesional steroids for the treatment of plantar fasciitis: a randomized, double-blinded study. Foot Ankle Int. 2013 Jan;34(1):8-14. doi: 10.1177/1071100712460215.
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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.
Fabian Krause, PD Dr. principal investigator
Dep. of Orthopaedic Surgery, Inselspital, University of Berne, Freiburgstrasse, 3010 Berne, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Botulinum toxin A, cortisone and Saline in people with Plantar Fasciitis, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabian Krause, PD Dr. (0041316322220, fabian.krause@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in foot pain (time frame: at 6 weeks, 3, 6 and 12 (24) months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02196155, which also lists 3 linked publications.
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 10 Dec 2024.