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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00006288
Date of registration:	09/07/2014
Prospective Registration:	No
Primary sponsor:	Kantonsspital AarauZentrum für Radio-Onkologie KSA-KSB
Public title:	Improvement in pain and function through analgesic and anti-inflammatory radiotherapy in patients with finger arthritis, medial/lateral epicondylitis or plantar fasciitis
Scientific title:	Improvement in pain and function through analgesic and anti-inflammatory radiotherapy in patients with finger arthritis, medial/lateral epicondylitis or plantar fasciitis
Date of first enrolment:	20/01/2013
Target sample size:	150
Recruitment status:	Recruiting
URL:	http://drks.de/search/en/trial/DRKS00006288
Study type:	interventional
Study design:	Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment
Phase:	N/A

Countries of recruitment
Switzerland

Contacts

Name:	Susanne Desborough
Address:	Tellstrasse 5001 Aarau Switzerland
Telephone:	+41628385408
Email:	susanne.desborough@ksa.ch
Affiliation:	Kantonsspital Aarau AGZentrum für Radio-Onkologie KSA-KSB

Name:	Brigitte Eberle
Address:	Tellstrasse 5001 Aarau Switzerland
Telephone:	+41628385387
Email:	brigitte.eberle@ksa.ch
Affiliation:	Kantonsspital Aarau AGZentrum für Radio-Onkologie KSA-KSB

Key inclusion & exclusion criteria

Inclusion criteria: Age over 40 year, Karnofsky Index at least 70%, Patients cannot be pregnant, Patients of child bearing age must use a medically acceptable form of contraception during the radiotherapy as well as 12 months after, Patients cannot have any congenital disease with increased sensitivity to radiation, absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial, before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations, patients will have been treated with conventional therapeutic interventions for at least 6 months
Exclusion criteria: congenital disease with increased sensitivity to radiation, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

Age minimum: 40 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

M77.1

Other enthesopathy of foot

M19.9

M77.3

M77.9

plantar fasciitis, epicondylitis, polyarthritis of the finger joints
M15.9
M19.9
M18
M76
M77.0
M77.1
M77.3
M77.5
M77.9

Calcaneal spur

Enthesopathy, unspecified

Medial epicondylitis

Arthrosis, unspecified

Enthesopathies of lower limb, excluding foot

M77.0

Arthrosis of first carpometacarpal joint

Lateral epicondylitis

M15.9

Polyarthrosis, unspecified

M77.5

Intervention(s)

Group 1: Analgesic and anti-inflammatory Radiotherapy. Radiotherapy is given twice a week for eight treatments, i.e. over 4 weeks. Each treatment lasts 10 – 15 minutes. The clinical assessments will be performed before the first treatment and 2, 6 and 12 months afer completion of radiotherapy. Furthermore, the patients will be asked to complete a questionnaire at these timepoints. The treatment will be repeated if necessary.

Primary Outcome(s)

Pain will be assessed using the Visual Analog Scale. Musculoskeletal function will be documented using a dynamometer for patients with hand and elbow disorders and a walking test will be performed for patients with plantar fasciitis. The HAQ (health assessment) and EQ-5D (quality of life) questionnaires will be completed by all patients. Assessments will be performed at baseline and at 2, 6 and 12 months after radiotherapy.

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Kantonsspital Aarau AGForschungsrat

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 25/10/2012
Contact:

Kanon AargauKantonale Ethikkommssion [Kanton Aargau Kantonale Ethikkommsision Bachstrasse 15 5001 Aarau]

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00006288#studyResults

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