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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Intra-articular steroid injections
* Radiation: Low-dose radiation therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective non-inferiority double-arm randomized controlled single centre trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intra-articular steroid injections<br>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<br>* 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.<br>|
| Experimental: Low-dose radiation therapy<br>LDRT is commonly used as treatment for benign degenerative inflammatory disorders | Radiation: Low-dose radiation therapy<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low dose radiation therapy, SPECT-CT, facet joint steroid injection