Condition category
Musculoskeletal Diseases
Date applied
16/05/2007
Date assigned
12/07/2007
Last edited
12/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.benignews.de

Contact information

Type

Scientific

Primary contact

Dr Marcus Niewald

ORCID ID

Contact details

Department of Radiooncology
Saarland University Hospital
Kirrberger Strasse 1
Homburg/Saar
D-66421
Germany
+49 (0)6841 162 4673
ramnie@uniklinikum-saarland.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

14/07

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics committee of the Saarland Medical Association, Saarbrücken (Germany), 14/05/2007, ref: 14/07

Study design

Multicentric controlled randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

21/05/2007

Overall trial end date

31/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (100 in each arm)

Participant 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

Recruitment start date

21/05/2007

Recruitment end date

31/05/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Radiooncology
Homburg/Saar
D-66421
Germany

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

Research organisation

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Costs are covered by the clinics involved:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Saarland University Hospital (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2008 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/18801159

Publication citations

  1. Protocol

    Niewald M, Seegenschmiedt MH, Micke O, Gräber S, , Randomized multicenter trial on the effect of radiotherapy for plantar Fasciitis (painful heel spur) using very low doses--a study protocol., Radiat Oncol, 2008, 3, 27, doi: 10.1186/1748-717X-3-27.

Additional files

Editorial Notes