Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis (NCT05852808) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis
Stopped: bad recruiting
Switzerland5 participantsStarted 2023-10-31
Plain-language summary
The goal of this clinical trial is to compare low-dose radiation therapy (LDRT) with intra-articular steroid injections in participants suffering from chronic lower back pain as cause of facet joint arthritis (FJA).
The main question\[s\] it aims to answer are:
* Is LDRT non-inferior to intra-articular steroid injections in terms of pain reduction
* Is there a difference in long-term pain reduction between LDRT and intra-articular steroid injections Participants will be randomly assigned to one of the two treatment groups.
Who can participate
Age range45 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with degenerative symptomatic facet joint osteoarthritis confirmed by MRI (lumbar spine) and standing X-ray
* Patients who underwent treatment for facet joint syndrome at the Dept. of Orthopaedic Surgery and Traumatology of KSA (Kantonsspital Aarau) or Dept. of Rheumatology of KSA or Dept. of Neurosurgery of KSA, onset of symptoms and treatment with pain medication and physiotherapy
* The informed consent form for participation in the study was signed
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Age ≥ 45 years
* Karnofsky Performance Status (KPS) ≥ 80 %
* Ability to take steroids and bridge or pause NOAC (New oral anticoagulants) / Marcoumar
* Show a positive Tracer-Uptake in the SPECT-CT in max. 4 facet joints of the lumbar spine (regardless of radiologic changes in MRI or CT)
* Immediate ≥ 70% pain reduction after 1 positive diagnostic infiltration of the suspected facet joint(s)
* Negative middle-/long-term effect (4-12 weeks after first steroid injection, defined as "NRS 5-10 at 4-12 weeks")
Exclusion Criteria:
* Any previous infiltration therapy in the suspected spine region (+/- 3 segments) within the last 3 years
* Any previous radiotherapy, radiofrequency ablation, other pain modulating interventions (e.g. thermos/-cryoablation or spinal cord stimulators) or surgery in the suspected spine region (+/- 3 segments)
* Prior or concurrent malignancy (≤ 5 years prior to enrolment …
What they're measuring
1
Change in pain level, measured on a numeric rating scale (NRS)
Timeframe: Baseline and 3 month after randomization