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

Conditions: 10009720
Facet joint
Zygapophyseal joint
10023213

Registration Number: NL-OMON38121

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

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

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain reduction (NRS).</p><br>

Secondary Outcome Measures

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