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Multicentric, prospective, randomized trial to examine the effect of radiotherapy on a painful heel spur depending on the dosage - Saarland Calcaneodynia Trial -

Multicentric, prospective, randomized trial to examine the effect of radiotherapy on a painful heel spur depending on the dosage - Saarland Calcaneodynia Trial - - FESPOSA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00004458
Enrollment
240
Registered
2012-10-15
Start date
2012-11-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M77.3

Interventions

Group 1: Radiotherapy with a total dose of 6.0Gy applied in single fractions of 1.0Gy twice a week (total duration 3 weeks) Group 2: Radiotherapy with a total dose of 6.0Gy in single fractions of 0.5G

Sponsors

Universitätsklinikum des Saarlandes
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: - clinical diagnosis of a painful plantar heel spur with a minumum duration of symptoms of 6 months - radiological diagnosis of a heel spur (conventional x-ray) - facultatively ultrasound, nmr, bone scan in order to diagnose plantar fasciitis - typical clinical symptoms (pain at the calcaneus) - typical functional deficits (limitation of painful walking distance - Karnofsky performance index >= 70% - Age >= 40 years - written informed consent

Exclusion criteria

Exclusion criteria: - Radiotherapy and trauma to the foot involved in anamneses - rheumatic diseases - arterial occlusion disease - intense venous insufficiency - lymphatic edema at the foot to be irradiated - pregnancy - time of breastfeeding - psychiatric illness - person in charge by law

Design outcomes

Primary

MeasureTime frame
Global quality of life, recorded using the SF-12 (short form 12) sum score, pain, recorded using the VAS scale (visual analogue scale); pain, use of aids for gait (orthopedic shoes); limitations during work, sports or daily life, gait using the calcaneodynia sum score published by Rowe at the following time points: before radiotherapy, after radiotherapy every 6 weeks up to 48 weeks. 6,12,24,36,48 weeks after radiotherapy the patients will be examined in the clinic, 18,30,42 weeks after radiotherapy the questionnaires will be mailed to the patients.

Secondary

MeasureTime frame
Global quality of life, recorded using the SF-12 (short form 12) single scores concerning somatic and psychic aspects of quality of life; pain, recorded using the VAS scale (visual analogue scale); pain, use of aids for gait (orthopedic shoes); limitations during work, sports or daily life, gait using the calcaneodynia single scores published by Rowe at the following time points: before radiotherapy, after radiotherapy every 6 weeks up to 48 weeks. 6,12,24,36,48 weeks after radiotherapy the patients will be examined in the clinic, 18,30,42 weeks after radiotherapy the questionnaires will be mailed to the patients.

Countries

Germany

Contacts

Public ContactMarcus Niewald

Klinik für Strahlentherapie und Radioonkologie, Universitätsklinikum des Saarlandes

marcus.niewald@uks.eu06841 1624673

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 15, 2026