Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity of Erlangen-Nürnberg Medical School

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Low-dose Radiation Therapy (LDRT) using MRI-based imaging techniques

    Procedure/Surgery

    LDRT using MRI-based imaging techniques by developing an MRI imaging protocol, deep learning-based image enhancement and resolution increase.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: Treatment Group1 intervention

Trial outcomes

Primary outcomes

1

Proof of clinical benefit of LDRT using pain scale

Visual analog scale: pain scale from 0-10 (0..no pain - 10..worst pain)

Time frame
36 months
2

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)

Time frame
36 months
3

Proof of clinical benefit of LDRT using Calcaneodynia score

Calcaneodynia score, scale from 0-100 (0..worst performance - 100..best performance)

Time frame
36 months
4

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.

Time frame
36 months

Secondary outcomes

1

Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol

Time frame
36 months
2

Correlation of subjective pain parameters with laboratory chemical examinations.

Time frame
36 months
3

Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum.

Time frame
36 months
4

Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.