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

ISRCTN	ISRCTN94220918
DOI	https://doi.org/10.1186/ISRCTN94220918
Secondary identifying numbers	14/07

Submission date: 16/05/2007
Registration date: 12/07/2007
Last edited: 12/08/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Marcus Niewald
Scientific

Department of Radiooncology
Saarland University Hospital
Kirrberger Strasse 1
Homburg/Saar
D-66421
Germany

Phone	+49 (0)6841 162 4673
Email	ramnie@uniklinikum-saarland.de

Study information

Study design	Multicentric controlled randomised trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	Radiotherapy for painful heel spur with a very low dose (0.6 Gy) is as effective regarding pain relief as a standard radiotherapy with a dose of 6.0 Gy.
Ethics approval(s)	Ethics committee of the Saarland Medical Association, Saarbrücken (Germany), 14/05/2007, ref: 14/07
Health condition(s) or problem(s) studied	Painful heel spur
Intervention	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 of 6.0 Gy in single fractions of 1.0 Gy twice weekly, total duration three weeks
Intervention type	Other
Primary outcome measure	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 outcome measures	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
Overall study start date	21/05/2007
Completion date	31/05/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200 (100 in each arm)
Key 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
Key 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
Date of first enrolment	21/05/2007
Date of final enrolment	31/05/2009

Locations

Countries of recruitment

Germany

Study participating centre

Department of Radiooncology

Homburg/Saar
D-66421
Germany

Sponsor information

German Cooperative Group on Radiotherapy for Benign Diseases (GCGBD) (Germany)
Research organisation

German Society for Radiation Oncology (DEGRO)
c/o Prof. Dr med. M. Heinrich Seegenschmiedt
Klinik für Radioonkologie, Strahlentherapie und Nuklearmedizin
Alfried Krupp Krankenhaus
Alfried Krupp Strasse 21
Essen
D-45117
Germany

Phone	+49 (0)201 434 2560
Email	heinrich.seegenschmiedt@krupp-krankenhaus.de

Funders

Funder type

Hospital/treatment centre

Costs are covered by the clinics involved:

No information available

Saarland University Hospital (Germany)

No information available

Alfried Krupp Hospital (Alfried-Krupp-Krankenhaus Essen) (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	18/09/2008		Yes	No