ArthrosisIMMO-LDRT02NCT05887284
Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis
A study testing low dose radiotherapy (0.5 Gy), mock radiation treatment and low dose radiotherapy (1.0 Gy) in people with Arthrosis and Osteoarthritis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
IMMO-LDRT02 is a prospective, placebo-controlled, double-blind, randomized trial to investigate the clinical efficacy of low dose radiation therapy (LDRT) in the treatment of arthrosis. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Read more about this study
- Who is it for?
- Ages 39 years and older
- Conditions the study is for
- Arthrosis, Osteoarthritis
- What is being tested?
- low dose radiotherapy (0.5 Gy), mock radiation treatment and low dose radiotherapy (1.0 Gy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed osteoarthritis according to ACR criteria (exclusion of other other arthritides and chronic rheumatoid arthritis via laboratory tests):
- Finger and wrist osteoarthritis
- Elbow arthrosis
- Shoulder arthrosis
- Knee arthrosis
- Ankle and foot joint arthrosis
- First time application of low-dose radiotherapy (LDRT) of the affected joint.
- Willingness to cooperate and accessibility of the patients (geographical proximity) for treatment and Follow-up care
Who cannot join
- Patients with tumor diseases
- People capable of childbearing or procreation who do not take consistent contraceptive measures during therapy
- Persistent drug, medication or alcohol abuse
- Patients for whom, in the physician's judgment, participation is not justifiable with regard to their well-being due to temporary withdrawal of standard medication.
- Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be made without doubt. To establish the diagnosis, the guidelines of the American College of Rheumatology (ACR) are followed.
- Earlier radiation therapy for treatment of cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Benjamin Frey, Dr.-Ing., +49 9131 85 ext. 44248, benjamin.frey@uk-erlangen.de
Anna Donaubauer, M.Sc., +49 9131 85 ext. 32311, anna-jasmina.donaubauer@uk-erlangen.de
About this study
IMMO-LDRT02 is a prospective, placebo-controlled, double-blind, randomized trial to investigate the clinical efficacy of low dose radiation therapy (LDRT) in the treatment of arthrosis. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale and identification of immunological changes.
Read the detailed description
The prevalence of chronic degenerative and inflammatory disorders, such as osteoarthritis, is constantly rising. As not all patients do respond adequately to the standard therapies, alternative treatment options such as low dose radiation therapy (LDRT) has gained further importance. LDRT is known to induce a long-lasting pain reduction, while having few side effects. Nonetheless, the detailed biological and immunological modes of action remain mostly elusive. In addition, there is a lack in placebo controlled randomised controlled trials (RCTs) proofing the pain-relieving effects of LDRT. So, the prospective, placebo-controlled, double-blind, randomized IMMO-LDRT02 trial to investigate the clinical efficacy of LDRT in the treatment of arthrosis should close this gap. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale (VAS) and identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group (IMMO-LDRT01 trial; ClinicalTrials.gov Identifier: NCT02653079).
- Conditions
- Arthrosis, Osteoarthritis
- Being tested
- low dose radiotherapy (0.5 Gy), mock radiation treatment, low dose radiotherapy (1.0 Gy)
- Keywords
- low dose radiotherapy, LDRT
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low dose radiotherapy (0.5 Gy)Radiation
12 times 0.5 Gy
mock radiation treatmentRadiation
6 times 0.0 Gy
low dose radiotherapy (1.0 Gy)Radiation
6 times 1.0 Gy
| Study group | Role | What they receive |
|---|---|---|
| Low dose Radiation Therapy | Experimental | In the test group, patients receive radiotherapy with six fractions of 0.5 Gy each over a period of 3 weeks, with 2 doses applied per week (total dose 3.0 Gy). After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients from the test group receive another irradiation series with six fractions of 0.5 Gy each according to the same schedule as before (total dose 3.0 Gy and in sum with the first series 6.0 Gy). Receives: Radiation: low dose radiotherapy (0.5 Gy) |
| Mock Radiation Therapy | Placebo comparator | In the control group, patients receive sham irradiation with six fractions of 0.0 Gy each over a period of 3 weeks, with 2 treatments per week. After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients in the control group, on the other hand, now also receive a radiotherapy with six fractions of 1.0 Gy each over a period of 3 weeks with 2 fractions per week (total dose 6.0 Gy). Receives: Radiation: mock radiation treatment; Radiation: low dose radiotherapy (1.0 Gy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in general pain (determined by visual analog scale (VAS) score) after LDRT compared to the placebo.
Determination of the general pain level by determining a so-called pain score which is calculated from the parameters pain level (VAS) and pain history (duration, frequency, maximum, quality and occurrence of pain). VAS is determined from 0 (no pain) to 10 (maximum pain). Pain history will also assessed bei an scale from 1 to 10.
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group.
Longitudinal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatment.
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Secondary outcomes (12)
Evidence of an objectionable clinical benefit of LDRT for finger/wrist osteoarthritis.
Analysis of the pain-free finger and hand force by using finger and hand strength meter.
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the efficacy of LDRT against placebo in modulating patient's well-being.
Determination of disease activity and pain using the international accepted EuroQol Research Foundation questionnaire EQ-5D-5L (IMMOLDRT02/EQ-5D-5L). Scale of EQ-5D-5L is from 5 (perfect well being) to 25 (illness with pain).
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the clinical efficacy of LDRT against placebo in fingers / wrists.
Determination of disease activity and pain in treated Fingers / Wrists using international disease specific questionnaires (AUSCAN score). Scaled on 5-point Likert, 100mm Visual Analog and 11-box Numerical Rating Scales, the AUSCAN™ 3.1 is a valid, reliable and responsive measure of outcome. Scale from 0 (no pain) to 100 (worst pain).
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the clinical efficacy of LDRT against placebo in shoulders.
Determination of disease activity and pain in treated shoulders using international disease specific questionnaires (Oxford Shoulder Questionnaire (OSS). Score from 12 (no trouble) to 60 impossible to do).
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the clinical efficacy of LDRT against placebo in knees.
Determination of disease activity and pain in treated knees using international disease specific questionnaires (Oxford Knee Questionnaire). Score from 12 (no trouble) to 60 impossible to do).
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the clinical efficacy of LDRT against placebo in foot and ankle joints.
Determination of disease activity and pain in treated foot and ankle joints using international disease specific questionnaires (EFAS European Foot and ankle score questionnaire). Score from 0 (no problems) to 40 impossible to do).
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Documentation and examination of general medication and pain medication.
Collection of patient's drug use by electronic medication diary.
Measured: From Randomisation (day 0) till end of the trial (day 336), assessed every 7 days from day 0 to day 336..
Investigation of the drop-out rate in the test and control group.
Determination of the patients number changing the group from placebo to treatment group.
Measured: Fraom day of randomisation (day 0) till patient's independent trial abort or day 336, whichever came first.
Comparison of the two series with single doses 0.5 Gy against one series with single dose 1.0 Gy with regard to pain score reduction and immunological changes
Determination of the general pain level by determining a so-called pain score which is calculated from the parameters pain level (VAS) and pain history (duration, frequency, maximum, quality and occurrence of pain). VAS is determined from 0 (no pain) to 10 (maximum pain). Pain history will also assessed bei an scale from 1 to 10.
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Modulation-matrix of immune cell function.
After blood collection, immune cells were separated and harvested. Cells are differentiated ex-vivo into mature immune cell sub populations, and their functionality is assessed by staining with surface markers using multicolour flowcytometry. Functionality is described by the amount of differentiable cells.
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Detection of chromosome aberrations
After blood collection, the immune cells were separated and harvested. The cells are examined ex-vivo for the occurrence of chromosomal aberrations using the multicolour Fluorescence in situ hybridization (FISH) method. The number of chromosomal defects as well as the type is recorded. Comparison is then made with normal human donors as well as the between study groups.
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Investigation of side effect profile of LDRT
The adverse effects of LDRT is recorded by official questionnaire
Measured: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthrosisStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Responsible party
- Sponsor
- Investigators
- Oliver Ott, Prof. Dr, Study director, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergBenjamin Frey, PD Dr.-Ing., Principal investigator, Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergThomas Weissmann, Dr., Principal investigator, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-NürnbergRainer Fietkau, Prof. Dr., Study chair, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887284
- Sponsor's protocol ID
- IMMO-LDRT02
- Acronym
- IMMO-LDRT02
- Status last verified
- Feb 2024
- First submitted
- 5 May 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Clinical Efficacy of Low-dose Ionizing Radiation in the Treatment of Osteoarthritis
- ClinicalTrials.gov ID
- NCT05887284
- Acronym / sponsor ID
- IMMO-LDRT02 / IMMO-LDRT02
- Conditions
- Arthrosis, Osteoarthritis
- Keywords
- low dose radiotherapy, LDRT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Johann Wolfgang Goethe University Hospital
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
IMMO-LDRT02 is a prospective, placebo-controlled, double-blind, randomized trial to investigate the clinical efficacy of low dose radiation therapy (LDRT) in the treatment of arthrosis. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale and identification of immunological changes.
Detailed description
The prevalence of chronic degenerative and inflammatory disorders, such as osteoarthritis, is constantly rising. As not all patients do respond adequately to the standard therapies, alternative treatment options such as low dose radiation therapy (LDRT) has gained further importance. LDRT is known to induce a long-lasting pain reduction, while having few side effects. Nonetheless, the detailed biological and immunological modes of action remain mostly elusive. In addition, there is a lack in placebo controlled randomised controlled trials (RCTs) proofing the pain-relieving effects of LDRT. So, the prospective, placebo-controlled, double-blind, randomized IMMO-LDRT02 trial to investigate the clinical efficacy of LDRT in the treatment of arthrosis should close this gap. Newly diagnosed or already existing arthroses of the fingers, wrists, shoulders, knees, ankles and feet will be enclosed. Finally, the evidence of clinical benefit from LDRT (6 x 0.5 Gy) will be compared to the placebo group (6 x 0 Gy), by determination via a visual analog scale (VAS) and identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group (IMMO-LDRT01 trial; ClinicalTrials.gov Identifier: NCT02653079).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose Radiation Therapy | Experimental | Radiation: low dose radiotherapy (0.5 Gy)In the test group, patients receive radiotherapy with six fractions of 0.5 Gy each over a period of 3 weeks, with 2 doses applied per week (total dose 3.0 Gy). After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients from the test group receive another irradiation series with six fractions of 0.5 Gy each according to the same schedule as before (total dose 3.0 Gy and in sum with the first series 6.0 Gy). |
| Mock Radiation Therapy | Placebo comparator | Radiation: mock radiation treatment, Radiation: low dose radiotherapy (1.0 Gy)In the control group, patients receive sham irradiation with six fractions of 0.0 Gy each over a period of 3 weeks, with 2 treatments per week. After the 1st follow-up (3 months after radiotherapy), patients receive the patients in both arms have the option to receive a 2nd series of radiotherapy in consultation with the study physician if no improvement in symptoms has occurred or patients are still not sufficiently satisfied with the outcome (this decision is still made by the physician and patient in a blinded manner). The patients in the control group, on the other hand, now also receive a radiotherapy with six fractions of 1.0 Gy each over a period of 3 weeks with 2 fractions per week (total dose 6.0 Gy). |
Who may qualify
- Ages
- 39 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed osteoarthritis according to ACR criteria (exclusion of other other arthritides and chronic rheumatoid arthritis via laboratory tests):
- First time application of low-dose radiotherapy (LDRT) of the affected joint.
- Willingness to cooperate and accessibility of the patients (geographical proximity) for treatment and Follow-up care
Key exclusion criteria (6 listed)
- Patients with tumor diseases
- People capable of childbearing or procreation who do not take consistent contraceptive measures during therapy
- Persistent drug, medication or alcohol abuse
- Patients for whom, in the physician's judgment, participation is not justifiable with regard to their well-being due to temporary withdrawal of standard medication.
- Patients in whom the diagnosis of osteoarthritis of the affected joint cannot be made without doubt. To establish the diagnosis, the guidelines of the American College of Rheumatology (ACR) are followed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low dose radiotherapy (0.5 Gy)12 times 0.5 Gy | Radiation | Low dose Radiation Therapy |
| mock radiation treatment6 times 0.0 Gy | Radiation | Mock Radiation Therapy |
| low dose radiotherapy (1.0 Gy)6 times 1.0 Gy | Radiation | Mock Radiation Therapy |
Primary outcome
Improvement in general pain (determined by visual analog scale (VAS) score) after LDRT compared to the placebo.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Determination of the general pain level by determining a so-called pain score which is calculated from the parameters pain level (VAS) and pain history (duration, frequency, maximum, quality and occurrence of pain). VAS is determined from 0 (no pain) to 10 (maximum pain). Pain history will also assessed bei an scale from 1 to 10.
Identification of immunological changes, which contribute to the success of therapy and are specifically found in the test group.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Longitudinal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatment.
12 secondary outcomes
Evidence of an objectionable clinical benefit of LDRT for finger/wrist osteoarthritis.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the efficacy of LDRT against placebo in modulating patient's well-being.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the clinical efficacy of LDRT against placebo in fingers / wrists.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the clinical efficacy of LDRT against placebo in shoulders.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the clinical efficacy of LDRT against placebo in knees.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Analysis of the clinical efficacy of LDRT against placebo in foot and ankle joints.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Documentation and examination of general medication and pain medication.
Time frame: From Randomisation (day 0) till end of the trial (day 336), assessed every 7 days from day 0 to day 336..
Investigation of the drop-out rate in the test and control group.
Time frame: Fraom day of randomisation (day 0) till patient's independent trial abort or day 336, whichever came first.
Comparison of the two series with single doses 0.5 Gy against one series with single dose 1.0 Gy with regard to pain score reduction and immunological changes
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Modulation-matrix of immune cell function.
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Detection of chromosome aberrations
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Investigation of side effect profile of LDRT
Time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver Ott, Prof. Dr study director
Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Benjamin Frey, PD Dr.-Ing. principal investigator
Translational Radiobiology, Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
Thomas Weissmann, Dr. principal investigator
Department of Radiation Oncology, Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low dose radiotherapy (0.5 Gy), mock radiation treatment and low dose radiotherapy (1.0 Gy) in people with Arthrosis and Osteoarthritis, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Frey, PD Dr.-Ing. (+49 9131 85 ext. 44248, benjamin.frey@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in general pain (determined by visual analog scale (VAS) score) after LDRT compared to the placebo. (time frame: Day 0 till end of the trial at the distinct time points of end of first LDRT series (day 28), first follow up (day 112), end of second LDRT series (day 140), second follow up (day 224), final follow up (day336).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.