ateral C1-2 Joint Pulsed Radiofrequency Application in the treatment of Cervicogenic Headache

• Conditions: Cervical headache; Headache from the neck; 10023213; 10019231

• Registration Number: NL-OMON34846
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 70

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameter is the proportion of patients that experience more<br /><br>than 50% pain relief at 1 month after either procedure. Numerical rating scale<br /><br>(NRS) scores for pain will be recored at baseline and at each follow-up visit.<br /><br>Secondary objectives include the rescue rates (proportion of patients with less<br /><br>than 50% pain relief requiring additional treatment).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes in this study includes<br /><br>1. The proportion of patients that require additional treatment 1 month after<br /><br>the first procedure<br /><br>2. The NRS (Numerical Rating Scale) scores at 1, 2 and 3 moth intervals using<br /><br>the PGIC (Patient Global Impression of Change) .<br /><br>3. Scores from 4 questionnaires<br /><br>a. SF-36 (Quality of Life)<br /><br>b. HIT-6 (Headache Impact)<br /><br>c. NDI (Neck Disability Index)<br /><br>d. MOS Sleep Scale (Medical Outcomes Study Sleep<br /><br>Scale)</p><br>