Coxarthrosis, Gonarthrosis
Conditions
Keywords
Low Dose Radiotherapy, Anti-inflammatory effects, Pain release, Quality of Life
Brief summary
This is a non-inferiority study in which the investigators compare two low-dose radiotherapy schemes, which are recommended from DEGRO Clinical Practice Guidelines (3 Gy vs 6 Gy) for the treatment of osteoarthritis and other osteodegenerative disorders. A first randomization will be carried out among the patients included in the study: * Patients in arm A will be treated at 3 Gy (0.5 Gy/fraction, 3 fractions/week), and patients in arm B will be treated at 6 Gy (1 Gy/fraction, 3 fractions/week). * Patients should not know the arm to which they have been randomized. * Once the treatment is finished, patients will be assessed at 8 weeks. If pain does not improve, a re-irradiation will be performed. If the patients were treated with 3 Gy a new randomization will be performed (3 vs 6 Gy again). If the patiens were treated with 6 Gy they will be re-irradiated with 6 Gy again. The investigators will analyze the results obtained depending on the dose received and depending on the location of the treatment.
Detailed description
Painfull skeletal disorders are susceptible to be treated with low-dose radiotherapy. DEGRO guidelines recommend a dose between 3 and 6 Gy at 0'5 Gy/fraction or 1 Gy/fraction respectively. The investigators want to verify that both treatments (3 and 6 Gy) are similar to improve the pain and function in patiens with gonarthrosis and coxarthrosis, and there are no differences between both treatments, therefore, 3 Gy is not less than 6 Gy. In this context, a prospective multicenter study is proposed. The study will include 338 patients to assess the efficacy of low dose irradiation (3 vs 6 Gy) in gonarthrosis and coxarthrosis.
Interventions
RADIATIONLow dose radiotherapy A
Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is randomized to 3 or 6 Gy again
RADIATIONLow dose radiotherapy B
Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is treated with 6 Gy again
Sponsors
Elekta Limited
Fundacion GenesisCare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
Patients label
Intervention model description
Arm 1: 3 Gy (repeated at 8 weeks if necessary. New ramdomization to 3 Gy or 6 Gy) Arm 2: 6 Gy (repeated at 8 weeks if necessry)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>50 years * Gonarthrosis or/and Coxarthrosis diagnose * At least 1 year of evolution * Non response to drug or surgery treatments * Risk of colateral side effects due to the comorbidity of the patient with conventional treatments.
Exclusion criteria
* Previous high dose radiotherapy in the same location * Conective tissue disease (LUPUS, reumathoid artritis, esclerodermia, Sd. Raynaud, Sd. Sjögren, polymiositis) * Inherited Hipersesitivity Sindromes (ataxia-telangiectasia, Fanconi's anaemya, Sd. Nijmegen, Sd. Gorlyn, Sd. Cockayne, Sd. Down, Sd. Gardner, Sd. Usher) * No follow up possibility * Other study inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain control at 8-12 weeks and every 6 months | At 8-12 weeks, 6 months, 12 months, 18 months and 24 months | To evaluate the non inferiority efficacy of low dose radiotherapy 3 or 6 Gy to change in pain with VAS (Visual Analogue Scale). The patient scores his painfrom 0 (no hurt) to 10 (hurts worst). It is better a low score. |
| Quality of Life at 8-12 weeks and every 6 months | At 8-12 weeks, 6 months, 12 months, 18 months and 24 months | To evaluate the non inferiority efficacy of low dose radiotherapy 3 or 6 Gy to change in pain with WOMAC scale (Western Ontario MacMaster Questionnaire). This questionnaire has 24 questions about pain, joint stiffness and joint function. It is better a low score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin toxicity at 8-12 weeks. | At 8-12 weeks. | Skin toxicity will be assessed and rated acording to the RTOG scale (0= no change over baseline; 1: Follicular, faint or dull erythema epilation, dry desquamation, decreased sweating; 2: Tender or bright erythema, patchy moist desquamation, moderate oedema; 3: Confluent, moist desquamation other tan skin folds, pitting oedema; 4: Ulceration haemorrhege, necrosis. |
Countries
Spain
Contacts
Primary ContactDaniel Rivas Sanchez, MD
Backup ContactRaul Hernaz, MD
Outcome results
None listed