Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis

• Status: Not yet recruiting
• Trial end date: 2025-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Silvia Gomez Ordonez

Criteria

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 in study) except:

nonmelanoma skin cancer, cervix carcinoma in situ, prostatic intraepithelial neoplasia) Contraindications to radiotherapy (for example connective tissue disorders such as scleroderma)

• 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

• Pregnancy, desire to have own children or lactation during study participation.