Clinical verification of knee osteoarthritis pain relief and functional improvement using low-dose radiation therapy
This clinical trial is a multicenter, randomized, single-blinded, exploratory clinical trial to evaluate the efficacy and safety of low-dose radiation for knee osteoarthritis patients. The experimental group is treated with low-dose irradiation 6 times for 3 weeks according to the dose determined for each group, and the control group is treated with sham irradiation. Both the experimental group and the control group visit the hospital 4 weeks after irradiation and at 4, 8, and 12 months to evaluate the efficacy and safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
114
low-dose radiation therapy to involved knee joint
sham radiation therapy to involved knee joint
Seoul National University Hospital / SMG-SNU Boramae Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
OMERACT-OARSI response rate
OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) response rate at 4 months. The OMERACT-OARSI criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.
Time frame: 4 months
OMERACT-OARSI response rate
OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) response rate at 4 weeks, 8 months, and 12 months. The OMERACT-OARSI criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment.
Time frame: 4 weeks, 8 months, 12 months
Changes in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) score
Total score (min 0, max 96 points, higher scores mean a worse outcome) and WOMAC score subscale (pain: min 0 max 20, stiffness: min 0 max 8, physical function: min 0 max 68)
Time frame: 4 weeks, 4 months, 8 months, 12 months
Changes in pain score
VAS score (min 0, max 100, higher scores mean a worse outcome)
Time frame: 4 weeks, 4 months, 8 months, 12 months
Changes in global assessment
PGA (Patient Global Assessment) score (min 0, max 100, higher scores mean a worse outcome)
Time frame: 4 weeks, 4 months, 8 months, 12 months
Radiological Changes Evaluated by Knee MRI
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Radiological Changes Evaluated by Knee MRI
Time frame: 4 months, 12 months
Radiological Changes Evaluated by Knee X-ray
Radiological Changes Evaluated by Knee X-ray
Time frame: 12 months
Changes in serum ESR (Erythrocyte sedimentation rate)
Changes in ESR (Erythrocyte sedimentation rate)
Time frame: 4 weeks, 4 months, 8 months, 12 months
Changes in serum CRP (C-reactive protein)
Changes in CRP (C-reactive protein)
Time frame: 4 weeks, 4 months, 8 months, 12 months
Change in the amount of analgesic rescue medication usage
Concomitant use of analgesics is prohibited until 4 months after irradiation, when the primary efficacy evaluation is scheduled. During this period, the use of a rescue drug (acetaminophen) may be permitted if the subjects need it for osteoarthritis. Monitor the amount of rescue medication prescribed to measure changes in usage during visits up to 4 months
Time frame: 4 weeks, 4 months