Calcaneal Spur
Conditions
Brief summary
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
Interventions
PROCEDURELow-dose Radiation Therapy (LDRT) using MRI-based imaging techniques
LDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase.
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 39 years * Typical clinical picture of plantar fasciitis for at least 3 months without associated trauma, other musculoskeletal co-morbidities or degenerative joint disease * Patients with first-time application of LDRT to the affected joint * Willingness to cooperate and accessibility of patients, especially geographical proximity, for treatment and follow-up * Patients for whom LDRT is indicated independently of the study * Karnofsky Index \>70%
Exclusion criteria
* Achillodynia ("dorsal" calcaneal spur) * Previous trauma to the foot (fracture, tendon rupture) * Musculoskeletal comorbidities of the foot * Acute infections/open wounds in the area of the tendon to be examined or other relevant damage to the tendon to be examined * Local steroid injections into the tendon prior to the study * Rheumatic or vascular diseases, lymphedema * Patients with tumors * Individuals of childbearing potential who do not use adequate contraceptive measures consistently during therapy * Persistent drug, medication or alcohol abuse * Patients who have already undergone radiotherapy for the treatment of cancer * Patients with an increased risk of an MRI examination, including the presence of metal implants, pacemakers or claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proof of clinical benefit of LDRT using pain scale | 36 months | Visual analog scale: pain scale from 0-10 (0..no pain - 10..worst pain) |
| Proof of clinical benefit of LDRT using QoL | 36 months | QoL: SF-8 (Short Form-8 Health Survey), scale from 0-100 (0..worst score - 100..best score) |
| Proof of clinical benefit of LDRT using Calcaneodynia score | 36 months | Calcaneodynia score, scale from 0-100 (0..worst performance - 100..best performance) |
| Proof of clinical benefit of LDRT using AOFAS Hindfoot Scale | 36 months | AOFAS Hindfoot Scale, Score ranges from 0 to 100, with healthy ankles receiving 100 points. |
| Proof of clinical benefit of LDRT using Roles and Maudsley Scale | 36 months | 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). |
Secondary
| Measure | 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 |
| 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 |
Countries
Germany
Contacts
CONTACTThomas PD. Dr. med. Weissmann, MD
CONTACTLisa Dr. rer. nat. Weissmann, PhD
Outcome results
None listed