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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00720694
Recruitment Status : Completed
First Posted : July 23, 2008
Last Update Posted : February 16, 2018
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Device: Duolith SD1 Device: Sham Duolith SD1 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2006
Primary Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Verum

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
Other Names:
  • Extracorporeal shock wave therapy
  • ESWT
Sham Comparator: Placebo / Sham
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



Primary Outcome Measures :
  1. Heel pain composite score [ Time Frame: Follow-Up 1 ]
    Sum of three VAS scales

  2. Roles and Maudsley Score [ Time Frame: 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 :
  1. Physician judgement of effectiveness [ Time Frame: Follow-Up 1 ]
    5-point scale ranging from very good to poor

  2. Subject satisfaction with treatment [ Time Frame: Follow-Up 1 ]
    7-point scale ranging from very satisfied to very unsatisfied

  3. Rate of success [ Time Frame: Follow-Up 1 ]
    at least 60% pain reduction in the single VAS scores

  4. Rate of success [ Time Frame: Follow-Up 2 ]
    at least 60% pain reduction in the single VAS scores

  5. Overall rate of success with regard to heel pain [ Time Frame: Follow-Up 1 ]
    at least 60% decrease of heel pain in at least two of the three VAS measurements

  6. Roles and Maudsley score rate of success [ Time Frame: Follow-Up 1 ]
    rating of excellent or good

  7. consumption of concomitant analgesic medication [ Time Frame: Follow-Up 1 ]
    medication

  8. Heel pain composite score [ Time Frame: Follow-Up 2 ]
    Sum of three VAS scales

  9. Roles and Maudsley Score [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720694


Locations
United States, California
Palo Alto Medical Fondation
Palo Alto, California, United States, 94301
United States, Connecticut
Connecticut Orthopedics Specialists
Hamden, Connecticut, United States, 06518
Advanced Footcare Specialists of Connecticut, LLC
Newtown, Connecticut, United States, 06470
United States, New York
Galli Podiatric Foot and Ankle Associates
New York, New York, United States, 10023
United States, Ohio
Ankle and Foot Care Centers
Boardman, Ohio, United States, 44512
United States, Washington
The Sports Medicine Clinic
Seattle, Washington, United States, 98133
Sponsors and Collaborators
Storz Medical AG

Publications:
Responsible Party: Dr. Pavel Novak, Director Product Development, Storz Medical AG
ClinicalTrials.gov Identifier: NCT00720694     History of Changes
Other Study ID Numbers: SMS2005
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases