Back to resultsEvaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis (LORAFA)
Primary Purpose
Lower Back Pain Chronic, Facet Joint Arthrosis, Osteoarthritis, Spine
Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Intra-articular steroid injections
Low-dose radiation therapy
Sponsored by
About this trial
This is an interventional treatment trial for Lower Back Pain Chronic focused on measuring Low dose radiation therapy, SPECT-CT, facet joint steroid injection
Eligibility Criteria
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.
Sites / Locations
- Kantonsspital AarauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intra-articular steroid injections
Low-dose radiation therapy
Arm Description
The intra-articular steroid injections are the most common standard of care to treat the lower back pain resulting from FJA.
LDRT is commonly used as treatment for benign degenerative inflammatory disorders
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Number of reported (serious) adverse events ((S)AE)
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
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
Efficacy of LDRT measured by percentage of patients with NRS<4
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05852808
Brief Title
Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis
Acronym
LORAFA
Official Title
Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis - A Prospective Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Silvia Gomez Ordonez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Back Pain Chronic, Facet Joint Arthrosis, Osteoarthritis, Spine
Keywords
Low dose radiation therapy, SPECT-CT, facet joint steroid injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective non-inferiority double-arm randomized controlled single centre trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intra-articular steroid injections
Arm Type
Active Comparator
Arm Description
The intra-articular steroid injections are the most common standard of care to treat the lower back pain resulting from FJA.
Arm Title
Low-dose radiation therapy
Arm Type
Experimental
Arm Description
LDRT is commonly used as treatment for benign degenerative inflammatory disorders
Intervention Type
Drug
Intervention Name(s)
Intra-articular steroid injections
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Low-dose radiation therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in pain level, measured on a numeric rating scale (NRS)
Description
Difference in pain score on a numeric rating scale (NRS) with values from 0 to 10 (0 = no pain, 10 = highest imaginable pain)
Time Frame
Baseline and 3 month after randomization
Secondary Outcome Measure Information:
Title
Number of reported (serious) adverse events ((S)AE)
Description
Toxicity of LDRT measured by number and description of reported (S)AE (serious adverse events)
Time Frame
Up to 12 months
Title
Percentage of patients with NRS<4 (equals responders) after first treatment session
Description
Efficacy of LDRT measured by percentage of patients with NRS<4 (equals responders) after first treatment session.
Time Frame
Up to 3.5 weeks
Title
Percentage of patients with NRS<4 (equals responders) after six months
Description
Efficacy of LDRT measured by percentage of patients with NRS<4
Time Frame
At six months
Title
Change in pain level, measured on a numeric rating scale (NRS)
Description
Difference in pain score on a numeric rating scale (NRS) with values from 0 to 10 (0 = no pain, 10 = highest imaginable pain)
Time Frame
Baseline, at 6 and 12 months after randomization
Title
Change in quality of life measured by the Short Form Health (SF)-36 questionnaire
Description
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
Time Frame
Baseline, at 3, 6 and 12 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Gomez Ordonez, Dr. med.
Phone
+41 62 838 02 15
Email
silvia.gomezordonez@ksa.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Helena Milavec, Dr. med.
Phone
+41 62 838 47 48
Email
helena.milavec@ksa.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Gomez Ordonez, Dr. med.
Organizational Affiliation
Kantonsspital Aarau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Gomez Ordonez, Dr. med.
Phone
+41 62 838 02 15
Email
silvia.gomezordonez@ksa.ch
First Name & Middle Initial & Last Name & Degree
Helena Milavec, Dr. med.
Phone
+41 62 838 47 48
Email
helena.milavec@ksa.ch
First Name & Middle Initial & Last Name & Degree
Silvia Gomez Ordonez, Dr. med.
First Name & Middle Initial & Last Name & Degree
Helena Milavec, Dr. med.
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis
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