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

Not Applicable

• Conditions: M77.3; Calcaneal spur

• Registration Number: DRKS00004458
• Lead Sponsor: niversitätsklinikum des Saarlandes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-15
• Study Completion: 2015-12-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 127

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

- 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.