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

Last updated: March 11, 2025
Sponsor: Silvia Gomez Ordonez
Overall Status: Terminated

Phase

N/A

Condition

Osteoarthritis

Treatment

Intra-articular steroid injections

Low-dose radiation therapy

Clinical Study ID

NCT05852808
2022-00272; ex22Gomez
  • Ages > 45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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. ofOrthopaedic Surgery and Traumatology of KSA (Kantonsspital Aarau) or Dept. ofRheumatology of KSA or Dept. of Neurosurgery of KSA, onset of symptoms and treatmentwith 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 theduration 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 lumbarspine (regardless of radiologic changes in MRI or CT)

  • Immediate ≥ 70% pain reduction after 1 positive diagnostic infiltration of thesuspected facet joint(s)

  • Negative middle-/long-term effect (4-12 weeks after first steroid injection, definedas "NRS 5-10 at 4-12 weeks")

Exclusion

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 modulatinginterventions (e.g. thermos/-cryoablation or spinal cord stimulators) or surgery inthe 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 intraepithelialneoplasia) Contraindications to radiotherapy (for example connective tissuedisorders such as scleroderma)

  • Any psychological, familial, sociological or geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule; thoseconditions should be discussed with the patient before registration in the trial

  • Pregnancy, desire to have own children or lactation during study participation.

Study Design

Total Participants: 5
Treatment Group(s): 2
Primary Treatment: Intra-articular steroid injections
Phase:
Study Start date:
October 31, 2023
Estimated Completion Date:
May 10, 2024

Study 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.

Connect with a study center

  • Kantonsspital Aarau

    Aarau, 5001
    Switzerland

    Site Not Available

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