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

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

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.

Study Overview

• Status: Terminated
• Conditions: Osteoarthritis, Spine; Lower Back Pain Chronic; Facet Joint Arthrosis
• Intervention / Treatment: Drug: Intra-articular steroid injections; Radiation: Low-dose radiation therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intra-articular steroid injections; The intra-articular steroid injections are the most common standard of care to treat the lower back pain resulting from FJA.	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.
Experimental: Low-dose radiation therapy; LDRT is commonly used as treatment for benign degenerative inflammatory disorders	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain level, measured on a numeric rating scale (NRS)	Difference in pain score on a numeric rating scale (NRS) with values from 0 to 10 (0 = no pain, 10 = highest imaginable pain)	Baseline and 3 month after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reported (serious) adverse events ((S)AE)	Toxicity of LDRT measured by number and description of reported (S)AE (serious adverse events)	Up to 12 months
Percentage of patients with NRS<4 (equals responders) after first treatment session	Efficacy of LDRT measured by percentage of patients with NRS<4 (equals responders) after first treatment session.	Up to 3.5 weeks
Percentage of patients with NRS<4 (equals responders) after six months	Efficacy of LDRT measured by percentage of patients with NRS<4	At six months
Change in pain level, measured on a numeric rating scale (NRS)	Difference in pain score on a numeric rating scale (NRS) with values from 0 to 10 (0 = no pain, 10 = highest imaginable pain)	Baseline, at 6 and 12 months after randomization
Change in quality of life measured by the Short Form Health (SF)-36 questionnaire	The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health or emotional wellbeing	Baseline, at 3, 6 and 12 months after randomization

Collaborators and Investigators

• Sponsor: Silvia Gomez Ordonez
• Investigators: Principal Investigator: Silvia Gomez Ordonez, Dr. med., Kantonsspital Aarau

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Actual): May 10, 2024
• Study Completion (Actual): May 10, 2024

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: SPECT-CT; Low dose radiation therapy; facet joint steroid injection
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Spinal Diseases; Spondylarthritis; Spondylitis; Back Pain; Osteoarthritis; Low Back Pain; Osteoarthritis, Spine
• Other Study ID Numbers: 2022-00272; ex22Gomez

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No