Fasciitis, PlantarRSWT_CPFNCT02679521
Radial Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciopathy
A study testing ESWT in people with Fasciitis, Plantar, run by Prof. Dr Mahmoud Ibrahim Ibrahim.
Trial summary
Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an efficient treatment option for heel pain associated with chronic proximal plantar fasciitis when administered in three sessions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Dec 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over the age of 18 years
- Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs: (i) pain in the morning or after sitting a long time; (ii) local pain where the fascia attaches to the heel; and (iii) increasing pain with extended walking or standing for more than 15 minutes
- History of six months of unsuccessful conservative treatment
- Therapy free period of at least four weeks before referral
- Signed informed consent
Who cannot join
- Bilateral plantar fasciitis
- Dysfunction of foot or ankle (for example, instability)
- Arthrosis or arthritis of the foot
- Infections or tumors of the lower extremity
- Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome)
- Vascular abnormality (for example, severe varicosities, chronic ischemia)
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- Operative treatments of the heel spur
- Hemorrhagic disorders and anticoagulant therapy
- Pregnancy
- Diabetes
About this study
Official title: The Effectiveness of Extracorporeal Shock Wave Therapy for Patients With Plantar Fasciitis Who Satisfy a Clinical Prediction Rule
Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an efficient treatment option for heel pain associated with chronic proximal plantar fasciitis when administered in three sessions. The present study tested the hypothesis that heel pain associated with chronic proximal plantar fasciitis can also be treated successfully with rESWT when only two treatment sessions are performed.
Read the detailed description
Plantar fasciitis, the most common cause of heel pain, accounts for approximately 11-15% of foot symptoms presenting to physicians. In the United States, more than two million individuals are treated for PF on an annual basis. The term Plantar Fasciitis implies an inflammatory condition by the suffix 'itis'. However, various lines of evidence indicate that this disorder is better classified as 'fasciosis' or 'fasciopathy'. Details about etiology, pathogenesis, risk factors, diagnosis and general treatment strategies for plantar fasciitis have been provided in a series of comprehensive reviews recently. Briefly, both athletes and the elderly commonly present to physicians with plantar fasciitis, and the diagnosis of plantar fasciitis is usually based on the patient's history and clinical examination. It has been recommended in the literature to start treatment of plantar fasciitis with conservative treatment modalities, including physical therapy, stretching, inserts/orthotics etc. For patients not responding to conservative treatment for 6 months (between 10% and 20% of all patients) extracorporeal shock wave therapy (ESWT) should be considered. In case a patient does not benefit from ESWT either, surgical intervention should be taken into account.
Several randomized, controlled trials of ESWT with focused shock waves for chronic plantar fasciitis were published, demonstrating favourable results in the range of 50% to 70% after a followup period of three months after treatment. Besides this, a recent study demonstrated safety and efficacy of radial extracorporeal shock wave therapy (rESWT) for chronic plantar fasciitis (Gerdesmeyer et al., Am J Sports Med 2008 Nov;36(11):2100-9). These authors administered rESWT or placebo treatment in three sessions, each two weeks (±4 days) apart and evaluated the treatment outcome at twelve weeks and twelve months after the first session. The authors found a statistically significant (p < 0.05) difference in the reduction of the mean Visual Analog Scale composite score between the patients treated with rESWT and the placebo-treated patients both at twelve weeks and twelve months from baseline.
To further evaluate the potential of rESWT to become a routine therapeutic modality in the treatment of chronic plantar fasciitis, the investigators of the present study identified the following questions not addressed in the study by Gerdesmeyer et al. (2008). First, it is unknown whether treatment success can also be reached by two rESWT sessions one week apart, rather than by three rESWT sessions each two weeks apart as applied by Gerdesmeyer et al. (2008). Anecdotal reports by colleagues in Europe indicated that this could indeed be the case. Second, immediate return to normal daily life activities (including sports activities) and normal daily shoe wear indicates that patients suffering from chronic plantar fasciitis and treated with rESWT experience profound pain relief already much earlier than three months after the first rESWT session, applied as first followup in the study by Gerdesmeyer et al. (2008).
Therefore the hypothesis was tested in the present prospective, randomized, double-blinded, placebo-controlled study that treatment of chronic plantar fasciopathy with two rESWT sessions one week apart will result in profound pain relief compared to placebo treatment already four weeks after the first rESWT treatment, lasting for at least six months.
- Conditions
- Fasciitis, Plantar
- Being tested
- ESWT, Placebo
- Keywords
- Extracorporeal Shock Wave Therapy, Painful Heel, Plantar fasciitis
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTDevice
Also called Swiss DolorClast
Radial extracorporeal shock wave therapy (rESWT) was performed by the principal investigator with a Swiss DolorClast device (EMS Electro Medical Systems Corporation; Dallas, Texas, USA).
The Swiss DolorClast device obtained Pre-Market Approval (PMA) by FDA as Class III orthopedic lithotripsy device to treat heel pain associated with chronic proximal plantar fasciitis on May 8, 2007 (PMA # P050004), and was re-classified as Class III Generator, Shock Wave, For Pain Relief (Product Code NBN) in the Spring 2009. The present study started on October 3, 2007.
Each patient received two sessions of rESWT one week apart, with 2,000 impulses per session (air pressure of the device set at 3.5 bar; impulses applied with the 15 mm applicator at frequency of 8 Hz).
PlaceboDevice
Placebo treatment was performed identically as rESWT but with a clasp on the heel that prevented transmission of the impulses from the applicator to the skin at the treatment site.
| Study group | Role | What they receive |
|---|---|---|
| rESWT | Active comparator | Radial extracorporeal shock wave therapy (rESWT). Receives: Device: ESWT |
| Placebo | Placebo comparator | Placebo treatment. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS score)
Measured: Change from Baseline Pain Score (VAS) at 6 months.
Secondary outcomes (1)
Quality of life (modified Roles & Maudsley score)
Measured: Change from Baseline Quality of Life Score (R&M) at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startOct 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr Mahmoud Ibrahim Ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr Mahmoud Ibrahim Ibrahim, Rocky Mountain University of Health Professions
- Investigators
- Mahmoud I Ibrahim, PhD, PT, Principal investigator, Rocky Mountain University of Health Professions, Provo, UT 84601, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679521
- Sponsor's protocol ID
- 070609-02
- Acronym
- RSWT_CPF
- Status last verified
- Feb 2016
- First submitted
- 3 Feb 2016
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ibrahim MI, Donatelli RA, Schmitz C, Hellman MA, Buxbaum F. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot Ankle Int. 2010 May;31(5):391-7. doi: 10.3113/FAI.2010.0391.
PubMed 20460065
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Extracorporeal Shock Wave Therapy for Patients With Plantar Fasciitis Who Satisfy a Clinical Prediction Rule
- ClinicalTrials.gov ID
- NCT02679521
- Acronym / sponsor ID
- RSWT_CPF / 070609-02
- Conditions
- Fasciitis, Plantar
- Keywords
- Extracorporeal Shock Wave Therapy, Painful Heel, Plantar fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Prof. Dr Mahmoud Ibrahim IbrahimUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Feb 2016 (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.
Radial extracorporeal shock wave therapy (rESWT) has been previously demonstrated as an efficient treatment option for heel pain associated with chronic proximal plantar fasciitis when administered in three sessions. The present study tested the hypothesis that heel pain associated with chronic proximal plantar fasciitis can also be treated successfully with rESWT when only two treatment sessions are performed.
Detailed description
Plantar fasciitis, the most common cause of heel pain, accounts for approximately 11-15% of foot symptoms presenting to physicians. In the United States, more than two million individuals are treated for PF on an annual basis. The term Plantar Fasciitis implies an inflammatory condition by the suffix 'itis'. However, various lines of evidence indicate that this disorder is better classified as 'fasciosis' or 'fasciopathy'. Details about etiology, pathogenesis, risk factors, diagnosis and general treatment strategies for plantar fasciitis have been provided in a series of comprehensive reviews recently. Briefly, both athletes and the elderly commonly present to physicians with plantar fasciitis, and the diagnosis of plantar fasciitis is usually based on the patient's history and clinical examination. It has been recommended in the literature to start treatment of plantar fasciitis with conservative treatment modalities, including physical therapy, stretching, inserts/orthotics etc. For patients not responding to conservative treatment for 6 months (between 10% and 20% of all patients) extracorporeal shock wave therapy (ESWT) should be considered. In case a patient does not benefit from ESWT either, surgical intervention should be taken into account.
Several randomized, controlled trials of ESWT with focused shock waves for chronic plantar fasciitis were published, demonstrating favourable results in the range of 50% to 70% after a followup period of three months after treatment. Besides this, a recent study demonstrated safety and efficacy of radial extracorporeal shock wave therapy (rESWT) for chronic plantar fasciitis (Gerdesmeyer et al., Am J Sports Med 2008 Nov;36(11):2100-9). These authors administered rESWT or placebo treatment in three sessions, each two weeks (±4 days) apart and evaluated the treatment outcome at twelve weeks and twelve months after the first session. The authors found a statistically significant (p < 0.05) difference in the reduction of the mean Visual Analog Scale composite score between the patients treated with rESWT and the placebo-treated patients both at twelve weeks and twelve months from baseline.
To further evaluate the potential of rESWT to become a routine therapeutic modality in the treatment of chronic plantar fasciitis, the investigators of the present study identified the following questions not addressed in the study by Gerdesmeyer et al. (2008). First, it is unknown whether treatment success can also be reached by two rESWT sessions one week apart, rather than by three rESWT sessions each two weeks apart as applied by Gerdesmeyer et al. (2008). Anecdotal reports by colleagues in Europe indicated that this could indeed be the case. Second, immediate return to normal daily life activities (including sports activities) and normal daily shoe wear indicates that patients suffering from chronic plantar fasciitis and treated with rESWT experience profound pain relief already much earlier than three months after the first rESWT session, applied as first followup in the study by Gerdesmeyer et al. (2008).
Therefore the hypothesis was tested in the present prospective, randomized, double-blinded, placebo-controlled study that treatment of chronic plantar fasciopathy with two rESWT sessions one week apart will result in profound pain relief compared to placebo treatment already four weeks after the first rESWT treatment, lasting for at least six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rESWT | Active comparator | Device: ESWTRadial extracorporeal shock wave therapy (rESWT). |
| Placebo | Placebo comparator | Device: PlaceboPlacebo treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults over the age of 18 years
- Diagnosis of painful heel syndrome by clinical examination, with the following positive clinical signs: (i) pain in the morning or after sitting a long time; (ii) local pain where the fascia attaches to the heel; and (iii) increasing pain with extended walking or standing for more than 15 minutes
- History of six months of unsuccessful conservative treatment
- Therapy free period of at least four weeks before referral
- Signed informed consent
Key exclusion criteria (10 listed)
- Bilateral plantar fasciitis
- Dysfunction of foot or ankle (for example, instability)
- Arthrosis or arthritis of the foot
- Infections or tumors of the lower extremity
- Neurological abnormalities, nerve entrapment (for example, tarsal tunnel syndrome)
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 |
|---|---|---|
| ESWTAlso: Swiss DolorClastRadial extracorporeal shock wave therapy (rESWT) was performed by the principal investigator with a Swiss DolorClast device (EMS Electro Medical Systems Corporation; Dallas, Texas, USA). The Swiss DolorClast device obtained Pre-Market Approval (PMA) by FDA as Class III orthopedic lithotripsy device to treat heel pain associated with chronic proximal plantar fasciitis on May 8, 2007 (PMA # P050004), and was re-classified as Class III Generator, Shock Wave, For Pain Relief (Product Code NBN) in the Spring 2009. The present study started on October 3, 2007. Each patient received two sessions of rESWT one week apart, with 2,000 impulses per session (air pressure of the device set at 3.5 bar; impulses applied with the 15 mm applicator at frequency of 8 Hz). | Device | rESWT |
| PlaceboPlacebo treatment was performed identically as rESWT but with a clasp on the heel that prevented transmission of the impulses from the applicator to the skin at the treatment site. | Device | Placebo |
Primary outcome
Pain (VAS score)
Time frame: Change from Baseline Pain Score (VAS) at 6 months.
1 secondary outcome
Quality of life (modified Roles & Maudsley score)
Time frame: Change from Baseline Quality of Life Score (R&M) at 6 months.
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 10 Feb 2016.
- Results publication: PubMed 20460065Ibrahim MI, Donatelli RA, Schmitz C, Hellman MA, Buxbaum F. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot Ankle Int. 2010 May;31(5):391-7. doi: 10.3113/FAI.2010.0391.
- Individual participant dataSharing planned: No
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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.
Mahmoud I Ibrahim, PhD, PT principal investigator
Rocky Mountain University of Health Professions, Provo, UT 84601, USA
Questions about this trial
What is this clinical trial studying?
A study testing ESWT in people with Fasciitis, Plantar, run by Prof. Dr Mahmoud Ibrahim Ibrahim.
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 5 inclusion and 10 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 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Pain (VAS score) (time frame: Change from Baseline Pain Score (VAS) at 6 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 NCT02679521, which also lists 1 linked publication.
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 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.