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Percutaneous pulsed radiofrequency treatment for lumbosacral radicular pain at the dorsal root ganglion

A randomised sham-controlled double-blind multicenter clinical trial to evaluate the percutaneous Pulsed RadioFrequency treatment at the Dorsal Root Ganglion

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN71336731
Enrollment
60
Registered
2013-07-23
Start date
2013-07-15
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

Lumbosacral radicular pain Musculoskeletal Diseases Radiculopathy

Interventions

Patients with lumbosacral radicular pain first receive a diagnostic block at the DRG: 1. Diagnostic injection at the DRG: The diagnostic injection is performed fluorosc

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 lumbosacral radicular pain for more than 3 months 3. Decrease in Numeric Rating Scale (NRS) of 2 or more / 10 on diagnostic block at the DRG

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. Aspecific low back pain 3. Corpus vertebrae problem 4. Progressive neurological deficits 5. Major psychiatric disorder (according to psychiatrists opinion) 6. Anticoagulation cannot be stopped 7. Pain in other parts of the body that is more severe (including facet joint -, SI joint - and discogenic pain) 8. Allergies to any medication used in the study 9. Pregnancy 10. Communication (language) difficulties (according to physicians opinion)

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

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