Lower Back Pain ChronicLORAFANCT05852808
Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis
A study testing Intra-articular steroid injections and Low-dose radiation therapy in people with Lower Back Pain Chronic and Facet Joint Arthrosis, run by Silvia Gomez Ordonez at 1 site in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Lower Back Pain Chronic, Facet Joint Arthrosis, Osteoarthritis, Spine
- What is being tested?
- Intra-articular steroid injections and Low-dose radiation therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 Oct 2023to 10 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 %
Show all 10Show fewer
- 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")
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis - A Prospective Randomized Clinical Trial.
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.
Read the 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.
- Being tested
- Intra-articular steroid injections, Low-dose radiation therapy
- Keywords
- Low dose radiation therapy, SPECT-CT, facet joint steroid injection
- Medical subject headings
- Osteoarthritis, Spine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular steroid injectionsDrug
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.
Low-dose radiation therapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Intra-articular steroid injections |
| Low-dose radiation therapy | Experimental | LDRT is commonly used as treatment for benign degenerative inflammatory disorders Receives: Radiation: Low-dose radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 3 month after randomization
Secondary outcomes (5)
Number of reported (serious) adverse events ((S)AE)
Toxicity of LDRT measured by number and description of reported (S)AE (serious adverse events)
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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
Measured: Baseline, at 3, 6 and 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start31 Oct 2023
- Primary completion10 May 2024
- Study completion10 May 2024
Why it stopped: bad recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective non-inferiority double-arm randomized controlled single centre trial
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silvia Gomez Ordonez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Silvia Gomez Ordonez, Kantonsspital Aarau
- Investigators
- Silvia Gomez Ordonez, Dr. med., Principal investigator, Kantonsspital Aarau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852808
- Sponsor's protocol ID
- 2022-00272; ex22Gomez
- Acronym
- LORAFA
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2023
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain Level Reduction After Low-dose Radiation in Symptomatic Facet Joint Arthritis - A Prospective Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05852808
- Acronym / sponsor ID
- LORAFA / 2022-00272; ex22Gomez
- Keywords
- Low dose radiation therapy, SPECT-CT, facet joint steroid injection
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: bad recruiting
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Silvia Gomez OrdonezUniversity, hospital or other
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 10 May 2024 (actual)
- Study completion
- 10 May 2024 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective non-inferiority double-arm randomized controlled single centre trial
| Arm | Type | Receives |
|---|---|---|
| Intra-articular steroid injections | Active comparator | Drug: Intra-articular steroid injectionsThe intra-articular steroid injections are the most common standard of care to treat the lower back pain resulting from FJA. |
| Low-dose radiation therapy | Experimental | Radiation: Low-dose radiation therapyLDRT is commonly used as treatment for benign degenerative inflammatory disorders |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular steroid injectionsThe 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. | Drug | Intra-articular steroid injections |
| Low-dose radiation therapyThe 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. | Radiation | Low-dose radiation therapy |
Primary outcome
Change in pain level, measured on a numeric rating scale (NRS)
Time frame: 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)
5 secondary outcomes
Number of reported (serious) adverse events ((S)AE)
Time frame: Up to 12 months
Percentage of patients with NRS<4 (equals responders) after first treatment session
Time frame: Up to 3.5 weeks
Percentage of patients with NRS<4 (equals responders) after six months
Time frame: At six months
Change in pain level, measured on a numeric rating scale (NRS)
Time frame: Baseline, at 6 and 12 months after randomization
Change in quality of life measured by the Short Form Health (SF)-36 questionnaire
Time frame: Baseline, at 3, 6 and 12 months after randomization
Results and safety
The study was stopped early (reason given: bad recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Gomez Ordonez, Dr. med. principal investigator
Kantonsspital Aarau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular steroid injections and Low-dose radiation therapy in people with Lower Back Pain Chronic and Facet Joint Arthrosis, run by Silvia Gomez Ordonez at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: bad recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level, measured on a numeric rating scale (NRS) (time frame: Baseline and 3 month after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.