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The clinical picture of calcaneal spur with plantar fasciitis is a debilitating disease that is difficult to treat with conservative and interventional measures. Radiotherapy has shown very good therapeutic results in retrospective data, which need to be clinically confirmed both subjectively and in terms of image morphology in a prospective approach.
Primary objective of the study:
To demonstrate a clinical benefit of LDRT: improvement of pain, functionality and quality of life after LDRT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group | Radiotherapy with a guideline-compliant (Radiotherapy of benign diseases; specialist group-specific evidence-based S2e guideline of the German Society for Radio-Oncology (DEGRO)) single dose of 0.5 Gy (3.0 Gy total dose) over 3 weeks and, if pain persists, a second series with the same dosage at 12-week intervals. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques | Procedure | LDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase. |
| Measure | Description | Time Frame |
|---|---|---|
| Proof of clinical benefit of LDRT using pain scale | Visual analog scale: pain scale from 0-10 (0..no pain - 10..worst pain) | 36 months |
| Proof of clinical benefit of LDRT using QoL | QoL: SF-8 (Short Form-8 Health Survey), scale from 0-100 (0..worst score - 100..best score) | 36 months |
| Proof of clinical benefit of LDRT using Calcaneodynia score | Calcaneodynia score, scale from 0-100 (0..worst performance - 100..best performance) | 36 months |
| Proof of clinical benefit of LDRT using AOFAS Hindfoot Scale | AOFAS Hindfoot Scale, Score ranges from 0 to 100, with healthy ankles receiving 100 points. | 36 months |
| Proof of clinical benefit of LDRT using Roles and Maudsley Scale | Roles and Maudsley scale is a 4-point subjective assessment used to evaluate patient pain and limitations in daily activities following treatment. It ranges from 1 (excellent result, no symptoms) to 4 (poor result, symptoms identical or worse than before treatment). | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol | 36 months | |
| Correlation of subjective pain parameters with laboratory chemical examinations. | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with heel spurs experience pain and inflammation, as do those with plantar fasciitis, which often goes hand in hand with it.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas PD. Dr. med. Weissmann, MD | Contact | +49913185 | 44209 | thomas.weissmann@uk-erlangen.de |
| Lisa Dr. rer. nat. Deloch, PhD | Contact | +49913185 | 44279 | lisa.deloch@uk-erlangen.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg | Erlangen | Bavaria | 91054 | Germany |
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| Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum. | 36 months |
| Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings. | 36 months |
| ID | Term |
|---|---|
| D036982 | Heel Spur |
| ID | Term |
|---|---|
| D005096 | Exostoses |
| D015576 | Hyperostosis |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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