Improvement in pain and function through analgesic and anti-inflammatory radiotherapy in patients with finger arthritis, medial/lateral epicondylitis or plantar fasciitis
Organizational Data
- DRKS-ID:
- DRKS00006288
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2014-07-09
- Last update in DRKS:
- 2014-07-09
- Registration type:
- Retrospective
Acronym/abbreviation of the study
No Entry
URL of the study
No Entry
Brief summary in lay language
We have successfully treated patients with conditions such as arthitis in our Institute of Radiation Oncology for many years. Radiotherapy can reduce the need for painkillers and other medication, and thus reduce drug-associated side effects (such as bleeding from the stomach and loss of kidney function related to non steroidal anti-inflammatory drugs). The aim of the study is to assess the response to radiotherapy using a questionnaire and clinical tests to document pain and movement. Analysis of the data should lead to an improvement and optimisation of the treatment. 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.
Brief summary in scientific language
In Germany, over 40,000 patients are irradiated for benign conditions each year and account for 10-20% of all radiotherapy patients. Indications include inflammatory soft tissue diseases, degenerative joint diseases and connective tissue diseases such as arthritis, calcaneal spur, tennis elbow and benign vascular tumours. The radiation dose is much lower than in cancer therapy but the success rate is high as recommended by DEGRO (Deutsche Gesellschaft für Radioonkologie . (Ärzte Zeitung Verlags-GmbH, Springer Medizin, 07.12.2011(http://www.aerztezeitung.de/medizin/krankheiten/skelett_und_weichteilkrankheiten/article/682313/strahlentherapie-fersensporn.html)). Radiotherapy can reduce the need for painkillers and other medication, and thus reduce drug-associated side effects (such as gastric haemorrhage and renal impairment secondary to non-steroidal anti-inflammatory drugs ) Strahlentherapie und Onkologie, Rolf Sauer, Verlag: Elsevier, München; Urban & Fischer) The aim of the study is to evaluate pain reduction and gain of function through the analgesic and anti-inflammatory effects of radiotherapy in patients with arthritis of the fingers, medial or lateral epicondylitis or plantar fasciitis. These patients will have been treated with conventional therapeutic interventions for at least 6 months. The efficacy of the radiotherapy will be repeatedly assessed during the first year following completion of therapy. Data will be collected using validated questionnaire and validated clinical tests. There will be no comparison between therapies. 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. Treatment will be delivered with 8 x 50 cGy, 2x/week and repeated as necessary.
Health condition or problem studied
- Free text:
- plantar fasciitis, epicondylitis, polyarthritis of the finger joints
- ICD10:
- M15.9 - Polyarthrosis, unspecified
- ICD10:
- M19.9 - Arthrosis, unspecified
- ICD10:
- M18 - Arthrosis of first carpometacarpal joint
- ICD10:
- M76 - Enthesopathies of lower limb, excluding foot
- ICD10:
- M77.0 - Medial epicondylitis
- ICD10:
- M77.1 - Lateral epicondylitis
- ICD10:
- M77.3 - Calcaneal spur
- ICD10:
- M77.5 - Other enthesopathy of foot
- ICD10:
- M77.9 - Enthesopathy, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 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.
Endpoints
- Primary outcome:
- 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:
- none
Study Design
- Purpose:
- Treatment
- Allocation:
- N/A (single arm study)
- Control:
-
- Uncontrolled/single arm
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Single (group)
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Switzerland
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Kantonsspital Aarau Aarau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2013-01-20
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 150
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 40 Years
- Maximum Age:
- no maximum age
- Additional 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
Addresses
Primary Sponsor
- Address:
- Kantonsspital AarauZentrum für Radio-Onkologie KSA-KSB5001 AarauSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Kantonsspital Aarau AGZentrum für Radio-Onkologie KSA-KSBDr. med. Brigitte EberleTellstrasse5001 AarauSwitzerland
- Telephone:
- +41628385387
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ksa.ch
Contact for Public Queries
- Address:
- Kantonsspital Aarau AGZentrum für Radio-Onkologie KSA-KSBSusanne DesboroughTellstrasse5001 AarauSwitzerland
- Telephone:
- +41628385408
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Kantonsspital Aarau AGZentrum für Radio-Onkologie KSA-KSBDr. med. Brigitte EberleTellstrasse5001 AarauSwitzerland
- Telephone:
- +41628385387
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ksa.ch
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Kantonsspital Aarau AGForschungsrat5001 AarauSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Kanon AargauKantonale Ethikkommssion [Kanton Aargau Kantonale Ethikkommsision Bachstrasse 15 5001 Aarau]Bachstrasse 155001 AargauSwitzerland
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2012-09-27
- Ethics committee number:
- 2012/069
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2012-10-25
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry