About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with heel spurs experience pain and inflammation, as do those with plantar fasciitis, which often goes hand in hand with it.
Trial design
Cohort
Prospective
Treatments tested in this trial
Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques
Procedure/SurgeryLDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase.
Treatment groups
Trial outcomes
Primary outcomes
Proof of clinical benefit of LDRT using pain scale
Visual analog scale: pain scale from 0-10 (0..no pain - 10..worst pain)
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)
Proof of clinical benefit of LDRT using Calcaneodynia score
Calcaneodynia score, scale from 0-100 (0..worst performance - 100..best performance)
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.
Secondary outcomes
Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol
Correlation of subjective pain parameters with laboratory chemical examinations.
Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum.
Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.