Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Placebo Controlled Study to Investigate the Effectiveness and Safety of Extracorporeal Shock Wave Therapy in Unsuccessful Conservatively Treated Subject Suffering From Painful Heel Syndrome

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Device: Duolith SD1
* Device: Sham Duolith SD1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verum<br>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. | Device: Duolith SD1<br> <br> * Other names: ESWT;|
| Sham Comparator: Placebo / Sham<br>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. | Device: Sham Duolith SD1<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician judgement of effectiveness | 5-point scale ranging from very good to poor | Follow-Up 1 | 
| Subject satisfaction with treatment | 7-point scale ranging from very satisfied to very unsatisfied | Follow-Up 1 | 
| Rate of success | at least 60% pain reduction in the single VAS scores | Follow-Up 1 | 
| Rate of success | at least 60% pain reduction in the single VAS scores | 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 | Follow-Up 1 | 
| Roles and Maudsley score rate of success | rating of excellent or good | Follow-Up 1 | 
| consumption of concomitant analgesic medication | medication | Follow-Up 1 | 
| Heel pain composite score | Sum of three VAS scales | 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. | Follow-Up 2 |