Plantar Fasciitis
Conditions
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.
Interventions
DEVICEDuolith SD1
DEVICESham Duolith SD1
Sponsors
Storz Medical AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of success | Follow-Up 1 | at least 60% pain reduction in the single VAS scores |
| 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 |
| Physician judgement of effectiveness | Follow-Up 1 | 5-point scale ranging from very good to poor |
| Heel pain composite score | Follow-Up 2 | Sum of three VAS scales |
| 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. |
| consumption of concomitant analgesic medication | Follow-Up 1 | medication |
| Subject satisfaction with treatment | Follow-Up 1 | 7-point scale ranging from very satisfied to very unsatisfied |
Countries
United States
Outcome results
None listed