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

Storz Medical

Status and phase: Completed; Phase 3

Conditions: Plantar Fasciitis

Treatments: Device: Sham Duolith SD1; Device: Duolith SD1

Study type: Interventional

Funder types: Industry

Identifiers

NCT00720694

SMS2005

Details and patient eligibility

About

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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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250 participants in 2 patient groups

Verum

Active Comparator group

Description:

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.

Treatment:

Device: Duolith SD1

Placebo / Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Duolith SD1