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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Active Comparator | 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. |
|
| Placebo / Sham | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duolith SD1 | Device |
|
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palo Alto Medical Fondation | Palo Alto | California | 94301 | United States | ||
| Connecticut Orthopedics Specialists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25948515 | Result | 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. |
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| Sham Duolith SD1 |
| Device |
|
| 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 |
| Hamden |
| Connecticut |
| 06518 |
| United States |
| Advanced Footcare Specialists of Connecticut, LLC | Newtown | Connecticut | 06470 | United States |
| Galli Podiatric Foot and Ankle Associates | New York | New York | 10023 | United States |
| Ankle and Foot Care Centers | Boardman | Ohio | 44512 | United States |
| The Sports Medicine Clinic | Seattle | Washington | 98133 | United States |
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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