NCT05852808

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

Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis - A Prospective Randomized Clinical Trial.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Silvia Gomez Ordonez · Academic / Other
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

However, there has been no published study providing scientific evidence by prospective randomized data on the effect of LDRT in patient suffering from facet osteoarthritis. LDRT seems a viable treatment method with anti-inflammatory potential and possible long-lasting benefit in pain resolution for patients with facet joint arthritis (FJA), which can prevent from an ultimate surgical treatment. The rationale of this trial is to generate scientific evidence that LDRT is an alternative non-invasive treatment option for FJA, whose primary outcome "pain reduction" is equivalent to the most common treatment intra-articular steroid injections.

Conditions

• Lower Back Pain Chronic
• Facet Joint Arthrosis
• Osteoarthritis, Spine

Interventions

Type	Name	Description
DRUG	Intra-articular steroid injections	The patient will be placed in prone position and the facet joints will be imaged by pa-radiation path with attention to radiation protection. 20 mg Kenacort + 1 ml Bupivacain (2.5 mg/ml) will be injected into the affected facet joints. The patient is monitored after the intervention for another 30 minutes before leaving the hospital. In order to track the pain level, the patient will be instructed to keep a pain diary. The patient will be contacted via telephone 72h after the intervention and asked about the pain level. The intervention is finished after one consultation.
RADIATION	Low-dose radiation therapy	The treatment consists of an informing consultation, a planning CT scan and a series of 10 radiation sessions delivered over 3.5 weeks ( = 12 visits in total). The clinical target volume (CTV) will be defined based on the MRI and SPECT/CT. Planning target volume (PTV) will be expanded in all directions by 0.5 cm beyond the CTV. Patients will be treated in a supine position with minimum 6 MV photons and a 3D-technique or volumetric modulated arc therapy (VMAT)-technique. A kilovolt (kV) and in exception a cone-beam CT will be performed before each treatment for positioning accuracy. A dose of 0.5 Gy x 10 fractions (3 times per week) will be delivered over 3.5 weeks. Each radiotherapy treatment session takes approximately 15 minutes. If a second radiotherapy series will be done (NRS 4-10 at visit 4), the radiotherapy dose und fractionation will be the same as the first series.

Timeline

• Start date: 2023-10-31
• Primary completion: 2024-05-10
• Completion: 2024-05-10
• First posted: 2023-05-10
• Last updated: 2025-03-14

Locations

1 site across 1 country: Switzerland