Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome
ESWT
Placebo Controlled Study to Investigate the Effectiveness and Safety of Extracorporeal Shock Wave Therapy in Unsuccessful Conservatively Treated Subject Suffering From Painful Heel Syndrome
1 other identifier
interventional
250
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 21, 2008
CompletedFirst Posted
Study publicly available on registry
July 23, 2008
CompletedFebruary 19, 2018
February 1, 2018
11 months
July 21, 2008
February 15, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Heel pain composite score
Sum of three VAS scales
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.
Follow-Up 1
Secondary Outcomes (9)
Physician judgement of effectiveness
Follow-Up 1
Subject satisfaction with treatment
Follow-Up 1
Rate of success
Follow-Up 1
Rate of success
Follow-Up 2
Overall rate of success with regard to heel pain
Follow-Up 1
- +4 more secondary outcomes
Study Arms (2)
Verum
ACTIVE COMPARATORDevice: 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 COMPARATORSham 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.
Interventions
Eligibility Criteria
You may qualify if:
- Age greater than 18 years
- ability of subject or legal respondent to give written informed consent
- signed informed consent
- diagnosis of painful heel syndrome
- months of unsuccessful conservative treatment
- washout from conservative treatment
- 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)
You may not qualify if:
- 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
- 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
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Storz Medical AGlead
Study Sites (6)
Palo Alto Medical Fondation
Palo Alto, California, 94301, United States
Connecticut Orthopedics Specialists
Hamden, Connecticut, 06518, United States
Advanced Footcare Specialists of Connecticut, LLC
Newtown, Connecticut, 06470, United States
Galli Podiatric Foot and Ankle Associates
New York, New York, 10023, United States
Ankle and Foot Care Centers
Boardman, Ohio, 44512, United States
The Sports Medicine Clinic
Seattle, Washington, 98133, United States
Related Publications (1)
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.
PMID: 25948515RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 21, 2008
First Posted
July 23, 2008
Study Start
June 1, 2006
Primary Completion
May 1, 2007
Last Updated
February 19, 2018
Record last verified: 2018-02