TerminatedNot Applicable

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

Stopped: bad recruiting

Switzerland5 participantsStarted 2023-10-31

Plain-language 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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain level, measured on a numeric rating scale (NRS)

Timeframe: Baseline and 3 month after randomization

Trial details

NCT IDNCT05852808

SponsorSilvia Gomez Ordonez

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-10

View on ClinicalTrials.gov More Lower Back Pain Chronic trials