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Multicentric randomised trial concerning the effect of radiotherapy for painful heel spur with very low doses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94220918
Enrollment
200
Registered
2007-07-12
Start date
2007-05-21
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Painful heel spur Musculoskeletal Diseases Musculoskeletal pain

Interventions

Radiotherapy to the plantar aponeurosis and the calcaneus: 1. Experimental arm: total dose of 0.6 Gy in single fractions of 0.1 Gy twice weekly, total duration three weeks 2. Standard arm: total dose

Sponsors

German Cooperative Group on Radiotherapy for Benign Diseases (GCGBD) (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Clinical proof of a painful heel spur with a duration of anamnesis of more than six months 2. Radiological proof of a heel spur using conventional radiographs 3. Facultatively: Magnetic Resonance Imaging (MRI/MRT), ultrasound, bone scan with proof of an inflammation of the plantar aponeurosis 4. Typical clinical symptoms: tenderness of the calcaneus 5. Typical functional deficits: limitation of the distance that can be walked without pain 6. Aged greater than or equal to 40 years 7. Karnofsky performance index greater than or equal to 70% 8. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous radiotherapy to the foot 2. Previous trauma to the foot 3. Additional rheumatic diseases, arterial obturation, severe venous insufficiency, lymphatic oedema of the leg involved 4. Pregnancy, time period of breastfeeding 5. Severe psychiatric disorder 6. Legal incapacitation

Design outcomes

Primary

MeasureTime frame
1. 12-item Short Form health survey (SF-12): summed score, measured three months after the end of radiotherapy 2. Calcaneodynia summed score, measured three months after the end of radiotherapy 3. Visual Analogue Scale (VAS) score, measured three months after the end of radiotherapy

Secondary

MeasureTime frame
1. SF-12: single scores, measured three months after the end of radiotherapy 2. Calcaneodynia single scores, measured three months after the end of radiotherapy 3. Painless time interval after therapy, measured three months after the end of radiotherapy

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026