M77.3
Conditions
Interventions
Group 1: Patients receiving low-dose radiation therapy (6 sessions of 0.5 Gy, 3 sessions per week).
Group 2: Patients receiving extracorporeal shock wave therapy (3 sessions, sessions at weekly interv
Sponsors
Universitätsklinikum Jena
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinical evidence of plantar fasciitis with symptoms lasting = 6 months Typical clinical symptoms with tenderness on palpation Treatment-resistant symptoms with no response to pharmacological and non-pharmacological measures, including patient-centered measures (including at least rest, stretching exercises, and insoles). Typical functional deficit: limitation of pain-free walking distance Karnofsky Performance Index = 70% Written patient consent to participate in the study (informed consent)
Exclusion criteria
Exclusion criteria: Previous radiation therapy or extracorporeal shock wave therapy on the affected foot within the last 12 months Previous trauma to the affected foot (e.g., fracture, tendon rupture) Active rheumatoid arthritis Symptomatic peripheral arterial occlusive disease Severe venous insufficiency Manifest lymphedema in the affected limb Pregnancy, breastfeeding Severe psychiatric illness Legal guardianship in medical matters by third parties
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Co-primary endpoints: Change (a) in average pain level within one week, measured as NRS score, and (b) in functional level, measured using calcaneodynia total score, after 6 months compared to before the start of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: ? Identification of predictive factors for response to LDRT and ESWT therapy and comparison of these factors between the therapy arms ? Quality of life, assessed using the modified Short Form 12 Health Survey (SF-12-ENSURE) questionnaire ? Duration of freedom from the need for further therapeutic measures ? Medication burden based on the Medication Quantification Scale Version 4.0 (MQS 4.0) ? Changes in the individual domains of the Calcaneodynia Score ? Maximum and minimum pain within one week, measured using NRS ? Subjective response via Patient Global Impression of Change (PGIC) questionnaire ? Decision regret using the Ottawa Decision Regret Scale (DRS) and perception of participatory decision-making using the questionnaire on participatory decision-making (revised 9-item version) (PEF-FB-9) ? Recording of side effects that occurred and comparison of the burden of therapy and its side effects using a self-developed questionnaire ? QALYs using the EuroQol 5 Dimensions – 5 Level (EQ-5D-5L) questionnaire ? ICER (derived from QALYs) ? Reliability and validity of the German translation of the Plantar Fasciitis Pain/Disability Scale (PFPS) | — |
Countries
Germany
Contacts
Public ContactMaximilian Römer
Universitätsklinikum Jena
Outcome results
None listed