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

Plantar Fasciitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720694
• Other study ID #: SMS2005
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2008
• Last updated: February 15, 2018
• Start date: June 2006

Study information

• Verified date: February 2018
• Source: Storz Medical AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• Duolith SD1

• Sham Duolith SD1

Locations

Country	Name	City	State
United States	Ankle and Foot Care Centers	Boardman	Ohio
United States	Connecticut Orthopedics Specialists	Hamden	Connecticut
United States	Galli Podiatric Foot and Ankle Associates	New York	New York
United States	Advanced Footcare Specialists of Connecticut, LLC	Newtown	Connecticut
United States	Palo Alto Medical Fondation	Palo Alto	California
United States	The Sports Medicine Clinic	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Storz Medical AG

Country where clinical trial is conducted

United States, 

References & Publications (1)

Gollwitzer H, Saxena A, DiDomenico LA, Galli L, Bouché 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 fa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heel pain composite score	Sum of three VAS scales	Follow-Up 1
Primary	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	Physician judgement of effectiveness	5-point scale ranging from very good to poor	Follow-Up 1
Secondary	Subject satisfaction with treatment	7-point scale ranging from very satisfied to very unsatisfied	Follow-Up 1
Secondary	Rate of success	at least 60% pain reduction in the single VAS scores	Follow-Up 1
Secondary	Rate of success	at least 60% pain reduction in the single VAS scores	Follow-Up 2
Secondary	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
Secondary	Roles and Maudsley score rate of success	rating of excellent or good	Follow-Up 1
Secondary	consumption of concomitant analgesic medication	medication	Follow-Up 1
Secondary	Heel pain composite score	Sum of three VAS scales	Follow-Up 2
Secondary	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