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

Lower Back Pain Chronic Clinical Trial

— LORAFA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05852808
• Other study ID #: 2022-00272; ex22Gomez
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: August 2025

Study information

• Verified date: November 2023
• Source: Kantonsspital Aarau
• Contact: Silvia Gomez Ordonez, Dr. med.
• Phone: +41 62 838 02 15
• Email: silvia.gomezordonez[@]ksa.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Back Pain
• Lower Back Pain Chronic
• Osteoarthritis
• Osteoarthritis, Spine

Intervention

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.

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau

Sponsors (1)

Lead Sponsor	Collaborator
Silvia Gomez Ordonez

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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