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A randomized, controlled, single-blinded, multicenter clinical trial to evaluate the percutaneous radiofrequency treatment of discogenic pain at the ramus communicans versus a sham-operated group

A randomized, controlled, single-blinded, multicenter clinical trial to evaluate the percutaneous radiofrequency treatment of discogenic pain at the ramus communicans versus a sham-operated group - Intervention for discogenic pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON38048
Enrollment
60
Registered
2012-02-07
Start date
2011-07-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Disc Discogenic

Interventions

Group 1 (treatment group): percutaneous RF heat lesion (80°C, 60 sec) at the ramus communicans
group 2 sham-operated group (same procedure as in group 1 except RF heat lesion). Both groups will receive graded activity.

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Age 18 years or older 2) Anamnesis and physical investigation suggestive of discogenic pain on lumbar level 3) Decrease in NRS of 2 or more / 10 on diagnostic ramus communicans 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

Design outcomes

Primary

MeasureTime frame
Pain reduction (NRS).—

Secondary

MeasureTime frame
Pain: Chronic Pain Acceptance Questionnaire (CPAQ), Four-Dimensional Symptom Questionnaire (4DSQ), Multidimensional Pain Inventory (MPI-DLV); Disability: Oswestry Disability Index (ODI); Generic health status: Rand-36; Kinesiophobia: Tampa Scale for Kinesiophobia (TSK); Coping: Pain Coping Inventory (PCI), Pain Cognition List (PCL-2003). Costs of intervention.—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)