Plantar FasciitisPhase 3ESWTNCT00720694
Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome
A Phase 3 study testing Duolith SD1 in people with Plantar Fasciitis, run by Storz Medical AG at 6 sites in United States.
Trial summary
The purpose of this study is to determine if the Storz Duolith SD1 is more effective than placebo for treatment of heel pain syndrome for patients who have failed conservative treatment with other therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Duolith SD1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2006to May 2007
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years
- ability of subject or legal respondent to give written informed consent
- signed informed consent
- diagnosis of painful heel syndrome
- 6 months of unsuccessful conservative treatment
- washout from conservative treatment
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- scores of 5 or greater on three VAS scales
- score of 3 or 4 on Roles and Maudsley Scale
- willingness to refrain from specified concomitant therapies
- willingness to keep subject diaries
- negative urine pregnancy test (if applicable) required use of contraception (if applicable)
Who cannot join
- tendon rupture, neurological or vascular insufficiencies
- inflammation of lower and upper ankle
- history of rheumatic disease, collagen, or metabolic disorders
- history of hyperthyroidism
- active malignant disease with or without metastasis
- Paget disease or calcaneal fat pad atrophy
Show all 31Show fewer
- osteomyelitis
- fracture of calcaneus
- immunosuppressive therapy
- long term (6 months or greater) treatment with corticosteroid
- insulin dependent diabetes, severe cardiac or respiratory disease
- coagulation disorder or therapy with anticoagulants or antiplatelet drugs
- bilateral painful heel
- planned treatment within 8 weeks of enrollment that may confound pain results
- less than required washout of other treatments
- previous surgery for painful heel
- previous unsuccessful treatment for painful heel with shock wave device
- history of allergy or hypersensitivity to local anesthetics
- significant abnormalities of hepatic function
- poor physical condition
- pregnant female
- active infection or history of chronic infection in treatment area
- history of peripheral neuropathy
- history of systemic inflammatory disease
- history of worker's compensation or litigation
- participation in study of investigational device within 30 days of selection or current active study participation
- in the opinion of the investigator, inappropriate for study inclusion
- unwilling to comply with study requirements
- implanted pacemaker, insulin pump, defibrillator, or neurostimulator
- implanted prosthetic device in area of treatment
- open wounds or skin rashes
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ankle and Foot Care Centers
Boardman, Ohio, 44512
Connecticut Orthopedics Specialists
Hamden, Connecticut, 06518
Galli Podiatric Foot and Ankle Associates
New York, New York, 10023
Advanced Footcare Specialists of Connecticut, LLC
Newtown, Connecticut, 06470
Palo Alto Medical Fondation
Palo Alto, California, 94301
The Sports Medicine Clinic
Seattle, Washington, 98133
About this study
Official title: Placebo Controlled Study to Investigate the Effectiveness and Safety of Extracorporeal Shock Wave Therapy in Unsuccessful Conservatively Treated Subject Suffering From Painful Heel Syndrome
The purpose of this study is to determine if the Storz Duolith SD1 is more effective than placebo for treatment of heel pain syndrome for patients who have failed conservative treatment with other therapies.
- Conditions
- Plantar Fasciitis
- Being tested
- Duolith SD1, Sham Duolith SD1
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duolith SD1Device
Also called Extracorporeal shock wave therapy, ESWT
Sham Duolith SD1Device
| Study group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | Device: Duolith SD1 (Storz Medical AG) - Focused Extracorporeal shock wave therapy.
The total energy flux density was increased continuously from 0.01 to 0.25 mJ/mm 2 within 500 introductory impulses. Thereafter, 2000 treatment impulses with 0.25 mJ/mm 2 (four impulses per second) were administered per session,and the interventionwas repeated up to a total of three sessions in weekly intervals. Receives: Device: Duolith SD1 |
| Placebo / Sham | Sham comparator | Sham Duolith SD1 (Storz Medical AG). The placebo group received identical sham intervention with an air- filled standoff that prevented the transmission of shock waves. The placebo handpiece was identical in design, shape, and weight to ensure that there was no way for the participants to identify the placebo handpiece. Receives: Device: Sham Duolith SD1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heel pain composite score
Sum of three VAS scales
Measured: Follow-Up 1
Roles and Maudsley Score
functional improvement on a four-level grading scale: excellent indicates no pain, full movement, and activity; good indicates occasional discomfort, full move- ment, and activity; fair indicates some discomfort after prolonged activity; and poor indicates pain-limiting activities.
Measured: Follow-Up 1
Secondary outcomes (9)
Physician judgement of effectiveness
5-point scale ranging from very good to poor
Measured: Follow-Up 1
Subject satisfaction with treatment
7-point scale ranging from very satisfied to very unsatisfied
Measured: Follow-Up 1
Rate of success
at least 60% pain reduction in the single VAS scores
Measured: Follow-Up 1
Rate of success
at least 60% pain reduction in the single VAS scores
Measured: Follow-Up 2
Overall rate of success with regard to heel pain
at least 60% decrease of heel pain in at least two of the three VAS measurements
Measured: Follow-Up 1
Roles and Maudsley score rate of success
rating of excellent or good
Measured: Follow-Up 1
consumption of concomitant analgesic medication
medication
Measured: Follow-Up 1
Heel pain composite score
Sum of three VAS scales
Measured: Follow-Up 2
Roles and Maudsley Score
functional improvement on a four-level grading scale: excellent indicates no pain, full movement, and activity; good indicates occasional discomfort, full move- ment, and activity; fair indicates some discomfort after prolonged activity; and poor indicates pain-limiting activities.
Measured: Follow-Up 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJun 2006
- Primary completionMay 2007
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 Plantar FasciitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Storz Medical AG
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720694
- Sponsor's protocol ID
- SMS2005
- Acronym
- ESWT
- Status last verified
- Feb 2018
- First submitted
- 21 Jul 2008
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Gollwitzer H, Saxena A, DiDomenico LA, Galli L, Bouche RT, Caminear DS, Fullem B, Vester JC, Horn C, Banke IJ, Burgkart R, Gerdesmeyer L. Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: a randomized, controlled multicenter study. J Bone Joint Surg Am. 2015 May 6;97(9):701-8. doi: 10.2106/JBJS.M.01331.
PubMed 25948515
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled Study to Investigate the Effectiveness and Safety of Extracorporeal Shock Wave Therapy in Unsuccessful Conservatively Treated Subject Suffering From Painful Heel Syndrome
- ClinicalTrials.gov ID
- NCT00720694
- Acronym / sponsor ID
- ESWT / SMS2005
- Conditions
- Plantar Fasciitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Storz Medical AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- May 2007 (actual)
- First posted
- 23 Jul 2008 (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.
The purpose of this study is to determine if the Storz Duolith SD1 is more effective than placebo for treatment of heel pain syndrome for patients who have failed conservative treatment with other therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Device: Duolith SD1Device: Duolith SD1 (Storz Medical AG) - Focused Extracorporeal shock wave therapy. The total energy flux density was increased continuously from 0.01 to 0.25 mJ/mm 2 within 500 introductory impulses. Thereafter, 2000 treatment impulses with 0.25 mJ/mm 2 (four impulses per second) were administered per session,and the interventionwas repeated up to a total of three sessions in weekly intervals. |
| Placebo / Sham | Sham comparator | Device: Sham Duolith SD1Sham Duolith SD1 (Storz Medical AG). The placebo group received identical sham intervention with an air- filled standoff that prevented the transmission of shock waves. The placebo handpiece was identical in design, shape, and weight to ensure that there was no way for the participants to identify the placebo handpiece. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age greater than 18 years
- ability of subject or legal respondent to give written informed consent
- signed informed consent
- diagnosis of painful heel syndrome
- 6 months of unsuccessful conservative treatment
Key exclusion criteria (31 listed)
- tendon rupture, neurological or vascular insufficiencies
- inflammation of lower and upper ankle
- history of rheumatic disease, collagen, or metabolic disorders
- history of hyperthyroidism
- active malignant disease with or without metastasis
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 |
|---|---|---|
| Duolith SD1Also: Extracorporeal shock wave therapy, ESWT | Device | Verum |
| Sham Duolith SD1 | Device | Placebo / Sham |
Primary outcome
Heel pain composite score
Time frame: Follow-Up 1
Sum of three VAS scales
Roles and Maudsley Score
Time frame: Follow-Up 1
functional improvement on a four-level grading scale: excellent indicates no pain, full movement, and activity; good indicates occasional discomfort, full move- ment, and activity; fair indicates some discomfort after prolonged activity; and poor indicates pain-limiting activities.
9 secondary outcomes
Physician judgement of effectiveness
Time frame: Follow-Up 1
Subject satisfaction with treatment
Time frame: Follow-Up 1
Rate of success
Time frame: Follow-Up 1
Rate of success
Time frame: Follow-Up 2
Overall rate of success with regard to heel pain
Time frame: Follow-Up 1
Roles and Maudsley score rate of success
Time frame: Follow-Up 1
consumption of concomitant analgesic medication
Time frame: Follow-Up 1
Heel pain composite score
Time frame: Follow-Up 2
Roles and Maudsley Score
Time frame: Follow-Up 2
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 19 Feb 2018.
- Results publication: PubMed 25948515Gollwitzer H, Saxena A, DiDomenico LA, Galli L, Bouche RT, Caminear DS, Fullem B, Vester JC, Horn C, Banke IJ, Burgkart R, Gerdesmeyer L. Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: a randomized, controlled multicenter study. J Bone Joint Surg Am. 2015 May 6;97(9):701-8. doi: 10.2106/JBJS.M.01331.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Duolith SD1 in people with Plantar Fasciitis, run by Storz Medical AG at 6 sites in United States.
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 11 inclusion and 31 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 19 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
What does this phase mean?
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?
Heel pain composite score (time frame: Follow-Up 1). 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?
On the ClinicalTrials.gov record for NCT00720694, 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 19 Feb 2018.