Clinical trial NCT00720694: Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome
Official title: Placebo Controlled Study to Investigate the Effectiveness and Safety of Extracorporeal Shock Wave Therapy in Unsuccessful Conservatively Treated Subject Suffering From Painful Heel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Plantar Fasciitis
Lead sponsor: Storz Medical AG
Sponsor class: INDUSTRY
First posted: 2008-07-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Heel pain composite score
timeFrame: Follow-Up 1
measure: Roles and Maudsley Score
timeFrame: Follow-Up 1
Secondary outcomes:
measure: Physician judgement of effectiveness
timeFrame: Follow-Up 1
measure: Subject satisfaction with treatment
timeFrame: Follow-Up 1
measure: Rate of success
timeFrame: Follow-Up 1
measure: Rate of success
timeFrame: Follow-Up 2
measure: Overall rate of success with regard to heel pain
timeFrame: Follow-Up 1
measure: Roles and Maudsley score rate of success
timeFrame: Follow-Up 1
measure: consumption of concomitant analgesic medication
timeFrame: Follow-Up 1
measure: Heel pain composite score
timeFrame: Follow-Up 2
measure: Roles and Maudsley Score
timeFrame: Follow-Up 2
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Fondation
state: California
city: Hamden
country: United States
facility: Connecticut Orthopedics Specialists
state: Connecticut
city: Newtown
country: United States
facility: Advanced Footcare Specialists of Connecticut, LLC
state: Connecticut
city: New York
country: United States
facility: Galli Podiatric Foot and Ankle Associates
state: New York
city: Boardman
country: United States
facility: Ankle and Foot Care Centers
state: Ohio
city: Seattle
country: United States
facility: The Sports Medicine Clinic
state: Washington
Study officials:
References:
citation: 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.