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

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Duolith SD1
Sham Duolith SD1
Sponsored by
Storz Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Palo Alto Medical Fondation
  • Connecticut Orthopedics Specialists
  • Advanced Footcare Specialists of Connecticut, LLC
  • Galli Podiatric Foot and Ankle Associates
  • Ankle and Foot Care Centers
  • The Sports Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Verum

Placebo / Sham

Arm 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.

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.

Outcomes

Primary Outcome Measures

Heel pain composite score
Sum of three VAS scales
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.

Secondary Outcome Measures

Physician judgement of effectiveness
5-point scale ranging from very good to poor
Subject satisfaction with treatment
7-point scale ranging from very satisfied to very unsatisfied
Rate of success
at least 60% pain reduction in the single VAS scores
Rate of success
at least 60% pain reduction in the single VAS scores
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
Roles and Maudsley score rate of success
rating of excellent or good
consumption of concomitant analgesic medication
medication
Heel pain composite score
Sum of three VAS scales
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.

Full Information

First Posted
July 21, 2008
Last Updated
February 15, 2018
Sponsor
Storz Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT00720694
Brief Title
Study of Effectiveness and Safety of Extracorporeal Shock Wave Therapy (ESWT) for Treatment of Painful Heel Syndrome
Acronym
ESWT
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Storz Medical AG

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verum
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo / Sham
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Duolith SD1
Other Intervention Name(s)
Extracorporeal shock wave therapy, ESWT
Intervention Type
Device
Intervention Name(s)
Sham Duolith SD1
Primary Outcome Measure Information:
Title
Heel pain composite score
Description
Sum of three VAS scales
Time Frame
Follow-Up 1
Title
Roles and Maudsley Score
Description
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.
Time Frame
Follow-Up 1
Secondary Outcome Measure Information:
Title
Physician judgement of effectiveness
Description
5-point scale ranging from very good to poor
Time Frame
Follow-Up 1
Title
Subject satisfaction with treatment
Description
7-point scale ranging from very satisfied to very unsatisfied
Time Frame
Follow-Up 1
Title
Rate of success
Description
at least 60% pain reduction in the single VAS scores
Time Frame
Follow-Up 1
Title
Rate of success
Description
at least 60% pain reduction in the single VAS scores
Time Frame
Follow-Up 2
Title
Overall rate of success with regard to heel pain
Description
at least 60% decrease of heel pain in at least two of the three VAS measurements
Time Frame
Follow-Up 1
Title
Roles and Maudsley score rate of success
Description
rating of excellent or good
Time Frame
Follow-Up 1
Title
consumption of concomitant analgesic medication
Description
medication
Time Frame
Follow-Up 1
Title
Heel pain composite score
Description
Sum of three VAS scales
Time Frame
Follow-Up 2
Title
Roles and Maudsley Score
Description
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.
Time Frame
Follow-Up 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Palo Alto Medical Fondation
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Facility Name
Connecticut Orthopedics Specialists
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Advanced Footcare Specialists of Connecticut, LLC
City
Newtown
State/Province
Connecticut
ZIP/Postal Code
06470
Country
United States
Facility Name
Galli Podiatric Foot and Ankle Associates
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
Ankle and Foot Care Centers
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
The Sports Medicine Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25948515
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.
Results Reference
result

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

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