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Percutaneous RadioFrequency treatment for FACET joint pain

Randomised sham-controlled double-blind multicenter clinical trials to evaluate the percutaneous radiofrequency treatment for facet joint pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17868852
Enrollment
60
Registered
2013-07-19
Start date
2012-03-01
Completion date
Unknown
Last updated
2020-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spine related pain disorders Musculoskeletal Diseases

Interventions

Patients with chronic low back pain in whom anamnesis, physical investigation and additional investigations point towards a facet joint problem first receive a diagnostic facet joint medial branch blo

Sponsors

Erasmus University Medical Centre (MC) (Netherlands)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or older 2. Anamnesis and physical investigation suggestive of facet joint pain on lumbar level 3. Decrease in Numeric Rating Scale (NRS) of 2 or more / 10 on diagnostic facet joint medial branch block

Exclusion criteria

Exclusion criteria: 1. Presence of red flags: possible fracture (major trauma, minor trauma in elderly or osteoporotic), possible tumor or infection (age >50 or <20, history of cancer, constitutional symptoms (fever, chills, weight loss), recent bacterial infection, IV drug abuse, immunosuppression, pain worsening at night or when supine), possible significant neurological deficit (severe or progressive sensory alteration or weakness, bladder or bowel dysfunction, evidence of neurological deficit (in legs or perineum in the case of low back pain) 2. Lumboradicular syndrome 3. Aspecific low back pain 4. Corpus vertebrae problem 5. Progressive neurological defecits 6. Major psychiatric disorder (according to psychiatrists opinion) 7. Anticoagulation cannot be stopped 8. Active infection 9. Pain in other parts of the body that is more severe 10. Allergies to any medication used in the study 11. Pregnancy 12. Communication (language) difficulties (according to physicians opinion)

Design outcomes

Primary

MeasureTime frame
Pain reduction (NRS) measured on the day of first consultation, 1, 3, 6 and 12 months after the treatment

Secondary

MeasureTime frame
1. Pain: Chronic Pain Acceptance Questionnaire (CPAQ), Four-Dimensional Symptom Questionnaire (4DSQ), Multidimensional Pain Inventory (MPI-DLV) measured on the day of first consultation, 3 and 12 months after the treatment 2. Disability: Oswestry Disability Index (ODI) measured on the day of first consultation, 3 and 12 months after the treatment 3. Generic health status: Rand-36 measured on the day of first consultation, 3 and 12 months after the treatment 4. Kinesiophobia: Tampa Scale for Kinesiophobia (TSK) measured on the day of first consultation, 3 and 12 months after the treatment 5. Coping: Pain Coping Inventory (PCI), Pain Cognition List (PCL-2003) measured on the day of first consultation, 3 and 12 months after the treatment 6. Costs of intervention

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026