Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome
- Conditions
- Plantar Fasciitis
- Interventions
- Device: Duolith SD1Device: Sham Duolith SD1
- Registration Number
- NCT00720694
- Lead Sponsor
- Storz Medical AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
- 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
- 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)
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Verum Duolith SD1 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. Placebo / Sham Sham Duolith SD1 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.
- Primary Outcome Measures
Name Time Method Heel pain composite score Follow-Up 1 Sum of three VAS scales
Roles and Maudsley Score 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.
- Secondary Outcome Measures
Name Time Method Heel pain composite score Follow-Up 2 Sum of three VAS scales
Physician judgement of effectiveness Follow-Up 1 5-point scale ranging from very good to poor
Overall rate of success with regard to heel pain Follow-Up 1 at least 60% decrease of heel pain in at least two of the three VAS measurements
Roles and Maudsley score rate of success Follow-Up 1 rating of excellent or good
Rate of success Follow-Up 2 at least 60% pain reduction in the single VAS scores
Roles and Maudsley Score Follow-Up 2 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.
Subject satisfaction with treatment Follow-Up 1 7-point scale ranging from very satisfied to very unsatisfied
consumption of concomitant analgesic medication Follow-Up 1 medication
Trial Locations
- Locations (6)
Ankle and Foot Care Centers
🇺🇸Boardman, Ohio, United States
Connecticut Orthopedics Specialists
🇺🇸Hamden, Connecticut, United States
The Sports Medicine Clinic
🇺🇸Seattle, Washington, United States
Palo Alto Medical Fondation
🇺🇸Palo Alto, California, United States
Advanced Footcare Specialists of Connecticut, LLC
🇺🇸Newtown, Connecticut, United States
Galli Podiatric Foot and Ankle Associates
🇺🇸New York, New York, United States