Cervical headache Headache from the neck
Conditions
Interventions
In this RCT, the effectiveness of lateral C1/2 joint pulsed radiofrequency
application (LPRF) is compared to conventional C3-5 facet denervation (MBRF).
The 2 procedures differs in several aspects.
Sponsors
Universitair Medisch Centrum Sint Radboud
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Male and female patients who are 18 years or more of age. Patients with a history of chronic, function-limiting cervicogenic headache of at least 3 months duration. Patients who are able to provide voluntary, written informed consent to participate in this evaluation. Patients willing to return for follow-ups. Patients without a history of recent surgical procedures (i.e. within the last 6 months)
Exclusion criteria
Exclusion criteria: Patients with uncontrolled major depression or psychiatric disorders. Patients with recent history of heavy opioid usage, chronic alcoholism or substance abuse. Patients with acute or uncontrolled medical illness, malignancy or poorly controlled epilepsy. Patients with chronic severe conditions that could interfere with the interpretations of the outcome assessments. Patients with fibromylagia or painful syndromes of unknown origin or associated with diffuse pains. Female patients who are pregnant or lactating, Patients with histories of adverse reactions to local anesthetic or steroids Patients with anatomical abnormalities on cervical spine X-ray that may result in technical difficulties for blocks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the proportion of patients that experience more than 50% pain relief at 1 month after either procedure. Numerical rating scale (NRS) scores for pain will be recored at baseline and at each follow-up visit. Secondary objectives include the rescue rates (proportion of patients with less than 50% pain relief requiring additional treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes in this study includes 1. The proportion of patients that require additional treatment 1 month after the first procedure 2. The NRS (Numerical Rating Scale) scores at 1, 2 and 3 moth intervals using the PGIC (Patient Global Impression of Change) . 3. Scores from 4 questionnaires a. SF-36 (Quality of Life) b. HIT-6 (Headache Impact) c. NDI (Neck Disability Index) d. MOS Sleep Scale (Medical Outcomes Study Sleep Scale) | — |
Countries
Netherlands
Outcome results
None listed