Clinical trial NCT06969820: Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis
Official title: Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Calcaneal Spur
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 35
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with heel spurs experience pain and inflammation, as do those with plantar fasciitis, which often goes hand in hand with it.

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


Eligibility criteria: 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

Primary outcomes:
measure: Proof of clinical benefit of LDRT using pain scale
timeFrame: 36 months
measure: Proof of clinical benefit of LDRT using QoL
timeFrame: 36 months
measure: Proof of clinical benefit of LDRT using Calcaneodynia score
timeFrame: 36 months
measure: Proof of clinical benefit of LDRT using AOFAS Hindfoot Scale
timeFrame: 36 months
measure: Proof of clinical benefit of LDRT using Roles and Maudsley Scale
timeFrame: 36 months
Secondary outcomes:
measure: Proof of an objectifiable clinical benefit of LDRT using MRI-based imaging techniques by developing an MRI imaging protocol
timeFrame: 36 months
measure: Correlation of subjective pain parameters with laboratory chemical examinations.
timeFrame: 36 months
measure: Correlation of subjective pain parameters, gait analyses and tendon elasticity with inflammatory components in the patient serum.
timeFrame: 36 months
measure: Correlation of immune cell subpopulations with disease severity by correlating them with MRI and laboratory findings.
timeFrame: 36 months
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Radiation Oncology, Translational Radiobiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
state: Bavaria
Study officials:
References: