RFD Versus Cervical Medial Branch Blocks in Chronic Degenerative Neck Pain
Unknown statusNot applicableNCT01743326
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Rationale: the facet joints are an important pain generator in chronic neck pain. The beneficial effect of radio frequency treatment (RFD) of the cervical facet joints has been described in a Randomized Clinical Trial (RCT) in patients with Whiplash Associated Disorders. In patients with degenerative neck complaints a positive effect has been described in observational studies. Given this positive effect performing a RCT of RFD in this patient population is indicated. Objective: to evaluate the effect of Radio Frequency treatment in patients with chronic degenerative neck pain. Study design: prospective, randomized, double blinded clinical trial. Study population: patients older than 25 years, referred to the University Pain Center of Maastricht and the Pain Center of Amphia hospital Breda, with chronic axial neck pain. Intervention: patients with at least 3 months of neck pain without radiation to the arm (only radiation beyond the shoulder) will be randomized in 2 groups. The first group (RFD + local anesthesia-group=intervention group) will receive RF treatment adjacent to the medial branch innervating the cervical facet joints after the application of bupivacaine 0.5 ml (0.25%). The second group (local anesthesia-group=control group) will only receive the application of 0.5 ml bupivacaine (0.25%) adjacent to the medial branch. The only difference between the two groups is the RF-denervation of the medial branches. Main study parameters/endpoints: the primary research question is to evaluate the extent of pain reduction induced by RF treatment (RFD + local anesthesia-group=intervention group) compared with the local anesthesia-group(control group. Following evaluation tools are used : Numeric Rating Scale (NRS), Patient global Impression of Change on a 7 point Likert Scale (PGIC), consumption of pain medication (MQS), Patient Specific Functional Scale, Quality of life scale (RAND 36), Hospital Anxiety and Depression scale (HADS), and Neck Disability Index (NDI, D…
Study details
- Official title
- Percutaneous Radiofrequency Denervation 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
- Conditions
- Facet Joint Arthritis
- Pain
- Radiofrequency Denervation
- Interventions
- Procedure: Radio Frequency Denervation
- Procedure: Local Anesthesia
- Sponsor
- Maastricht University Medical Center
- Start date
- 2012-11
- Primary completion
- 2015-06
- Sex
- All
- Age range
- from 25 Years to 90 Years
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Patient's age \> 25 year * Signs of degeneration on lateral X-ray * Cervical facets to be treated between C2 and C7 * Pain for at least 3 months and conservative treatment medication (=paracetamol, Non-Steroidal anti-inflammatory Drugs (NSAID) and/or physical therapy) prior to referral to the pain clinic * Neck pain on a Numeric Rating Scale ≥ 5 Exclusion Criteria: * Radiation beyond the shoulder/radicular pain * Shoulder pain/pathology * The complaints are directly related to traumatic event e.g. Whiplash (WAD) * Patient is pregnant, or pregnancy is suspected * Patient has a cardiac pacemaker, automatic defibrillator or any leads in the neck area * Allergy to contrast media or drugs to be used in the procedure * History of anterior fusion at the cervical level to be treated * Patient is simultaneously participating in another device or drug study related to cervical pain. * Patient has a spinal fracture, tumor or infection. * Patient has a central cord lesion in the cervical spine * Neurologic deficit * Evidence of disc herniation (extruded, sequestered on MRI imaging)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01743326