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Percutaneous Radiofrequency Treatment of the Cervical Facet joints compared with Cervical Medial Branch block of the Facet Joints for Patients with Chronic Degenerative Neck pain : A Prospective Randomized Clinical Study

Percutaneous Radiofrequency Treatment of the Cervical Facet joints compared with Cervical Medial Branch block of the Facet Joints for Patients with Chronic Degenerative Neck pain : A Prospective Randomized Clinical Study - RFD of the cervical facet joints versus Cervical Medial Branch block.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON37554
Enrollment
84
Registered
2012-09-07
Start date
2013-02-07
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

cervical facet degeneration facet arthrosis

Interventions

Patients with at least 3 months of neck pain without radiation to the arm will be randomized in 2 groups. The first group (RFD group) will receive a RF treatment adjacent to the medial branch inner

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) 1) Patient*s age > 25 year 2) Signs of degeneration on lateral X-ray 3) Cervical facets to be treated between C2 and C7 4) Pain for at least 3 months and conservative treatment prior to referral to the painclinic; medication (paracetamol, NSAID*s) and/or physical therapy 5) Neck pain NRS score * 5

Exclusion criteria

Exclusion criteria: 1) Radiation beyond the shoulder/radiculair pain 2) Shoulder pain/pathology 3) The complaints are directly related to traumatic event e.g. Whiplash (WAD) 4) Patient is pregnant, or pregnancy is suspected 5) Patient has a cardiac pacemaker, automatic defibrillator or any leads in the neck area 6) Allergy to contrast media or drugs to be used in the procedure 7) History of anterior fusion at the cervical level to be treated 8) Patient is simultaneously participating in another device or drug study related to cervical pain. 9) Patient has a spinal fracture, tumor or infection. 10) Patient has a central cord lesion in the cervical spine 11) Neurologic deficit 12) Evidence of disc herniation (extruded, sequestered on MRI imaging)

Design outcomes

Primary

MeasureTime frame
The primary research question is to evaluate the extent of pain reduction induced by RF treatment (RFD group) compared with the control group. Following evaluation tools are used : Numeric Rating Scale, Global Perceived Effect on Likert Scale.

Secondary

MeasureTime frame
Consumption of pain medication (MQS), Patient Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression scale (HADS), and Neck Disabilty Index (Dutch version).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)