A randomized, controlled, single-blinded, multicenter clinical trial to evaluate the percutaneous radiofrequency treatment of facet joint pain versus a sham-operated group

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38121

Enrollment

Registered

2012-02-08

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

Facet joint Zygapophyseal joint

Interventions

Group 1 (treatment group): percutaneous RF heat lesion (80º C during 60 sec. per level) at the medial branches of the primary dorsal rami on three adjecent levels

group 2 (sham-operated group) same procedure as in group 1 except RF heat lesion. Both groups will receive graded activity.

Eligibility

Age

18 Years to 99 Years

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 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

Design outcomes

Primary

Measure	Time frame
Pain reduction (NRS).	—

Secondary

Measure	Time 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)