Skip to content

A Randomised Placebo-Controlled Double-blinded High Cervical Epidural Neurostimulation Trial in patients with Intractable Cervicogenic Headache

A Randomised Placebo-Controlled Double-blinded High Cervical Epidural Neurostimulation Trial in patients with Intractable Cervicogenic Headache - High Cervical Neurostimulation in Intractable Cervicogenic Headache

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35036
Enrollment
8
Registered
2010-06-28
Start date
2010-02-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Pesistant Headache associated with Chronic Neck Pain Resistant Head and Neck Pain

Interventions

High Cervical Epidural Neurostimulation We describe the standard approach to cervical epidural lead insertion. After local anaesthesia with Lignocaine 1%, the epidural space will be reached with a

Sponsors

Anesthesiologie, Pijn en Palliatieve Geneeskunde
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male and female patients who are 18 years or more of age. 2. Patients with a history of chronic, function-limiting cervicogenic headache of at least 12 months duration. 3. Patients who are able to provide voluntary, written informed consent to participate in this evaluation. 4. Patients willing to return for follow-ups. 5. Patients without a history of recent surgical procedures (i.e. within the last 6 months)

Exclusion criteria

Exclusion criteria: 1. Patients with uncontrolled major depression or psychiatric disorders. 2. Patients with recent history of heavy opioid usage, chronic alcoholism or substance abuse. 3. Patients with acute or uncontrolled medical illness, malignancy or poorly controlled epilepsy. 4. Patients with chronic severe conditions that could interfere with the interpretations of the outcome assessments. 5. Patients with fibromylagia or painful syndromes of unknown origin or associated with diffuse pains. 6. Female patients who are pregnant or lactating, 7. Patients with histories of adverse reactions to local anesthetic 8. Patients with anatomical abnormalities on cervical spine X-ray that may result in technical difficulties for blocks

Design outcomes

Primary

MeasureTime frame
The main study parameter is the mean daily VAS (visual analogue scale) pain scores during the 4 days of test-stimulation versus the 4 days of placebo-stimulation. Objective parameters in the form of QST measurements will also be obtained.

Secondary

MeasureTime frame
Secondary parameters includes: 1. QST measurements over: a. Thenar eminence on the hand b. Suboccipital area (2 cm inferior and lateral to the occipital protuberance) c. V2-3 dermatome (over the masseter muscle) 2. Qualitiy of Life using the SF-12 which will be applied at baseline assessment and at the last consult after the trial.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)