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

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

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.

Study Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Device: Duolith SD1; Device: Sham Duolith SD1

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: ESWT; Extracorporeal shock wave therapy
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Storz Medical AG

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 22, 2008
• First Posted (Estimate): July 23, 2008

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: SMS2005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes