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

NCT05852808 | Terminated

• 1 other identifier: 2022-00272; ex22Gomez
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Low dose radiation therapy; SPECT-CT; facet joint steroid injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of reported (serious) adverse events ((S)AE)

  Up to 12 months

• 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

  At six months

• Change in pain level, measured on a numeric rating scale (NRS)

  Baseline, at 6 and 12 months after randomization

• Change in quality of life measured by the Short Form Health (SF)-36 questionnaire

  Baseline, at 3, 6 and 12 months after randomization

Study Arms (2)

Intra-articular steroid injections

ACTIVE COMPARATOR

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

Low-dose radiation therapy

EXPERIMENTAL

LDRT is commonly used as treatment for benign degenerative inflammatory disorders

Radiation: Low-dose radiation therapy

Interventions

Intra-articular steroid injections DRUG

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.

Intra-articular steroid injections

Low-dose radiation therapy RADIATION

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.

Low-dose radiation therapy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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")

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silvia Gomez Ordonez: lead

Study Sites (1)

Kantonsspital Aarau

Aarau, 5001, Switzerland

Location

MeSH Terms

Conditions

Osteoarthritis, Spine

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Osteoarthritis; Arthritis; Joint Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Silvia Gomez Ordonez, Dr. med.

  Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Model Details: Prospective non-inferiority double-arm randomized controlled single centre trial

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 10, 2023
• Study Start: October 31, 2023
• Primary Completion: May 10, 2024
• Study Completion: May 10, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

CH (1)