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

NCT05852808 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Silvia Gomez Ordonez

    lead OTHER

Principal Investigators

  • Silvia Gomez Ordonez, Dr. med. · Kantonsspital Aarau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-05-10
Completion
2024-05-10

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05852808 on ClinicalTrials.gov