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

Sponsor

Silvia Gomez Ordonez (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05852808

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lower Back Pain Chronic Facet Joint Arthrosis Osteoarthritis, Spine	Drug: Intra-articular steroid injections Radiation: Low-dose radiation therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective non-inferiority double-arm randomized controlled single centre trialProspective non-inferiority double-arm randomized controlled single centre trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Number of reported (serious) adverse events ((S)AE) [Up to 12 months]
Toxicity of LDRT measured by number and description of reported (S)AE (serious adverse events)
Percentage of patients with NRS<4 (equals responders) after first treatment session [Up to 3.5 weeks]
Efficacy of LDRT measured by percentage of patients with NRS<4 (equals responders) after first treatment session.
Percentage of patients with NRS<4 (equals responders) after six months [At six months]
Efficacy of LDRT measured by percentage of patients with NRS<4
Change in pain level, measured on a numeric rating scale (NRS) [Baseline, at 6 and 12 months after randomization]
Difference in pain score on a numeric rating scale (NRS) with values from 0 to 10 (0 = no pain, 10 = highest imaginable pain)
Change in quality of life measured by the Short Form Health (SF)-36 questionnaire [Baseline, at 3, 6 and 12 months after randomization]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.