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Clinical Trials/NCT05464212
NCT05464212
Completed
Not Applicable

Comparison of the Efficacy of Ultrasound-guided Greater Occipital Nerve Block and Pulsed Radiofrequency Therapy in Chronic Migraine Patients: A Randomized Controlled Double-Blind Study

Eskisehir Osmangazi University1 site in 1 country32 target enrollmentApril 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Migraine, Headache
Sponsor
Eskisehir Osmangazi University
Enrollment
32
Locations
1
Primary Endpoint
Visuel Analog Scale
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Chronic migraine (CM) is related to headache-related disability and reduced quality of life. Therefore, patients with CM require preventive treatment. The aim of this double-blind, comparative-effectiveness study was to compare ultrasound-guided great occipital nerve (GON) block and pulsed radiofrequency (PRF) application in CM patients.

The study consisted of 2 groups: GON block (group GONB) and GON block + pulsed RF (group GONB+PRF). Each group had 16 patients. Ultrasound-guided GONB was performed to locate the nerve more accurately. With 0.5 Hz sensorial stimulation, a 5-cm-long radiofrequency needle was advanced under ultrasound guidance in both groups. GON block was performed in all patients by administering 5mg bupivacaine through a PRF needle. After the GON block, the PRF neuromodulation was applied at 42 degrees for 4 minutes in the GONB-PRF group. In the GONB group, no pulse was given. The patients were examined for follow-ups at the 1st, 2nd, 3rd, and 6th months after the procedure. The severity and the number of migraine attacks, and the number of analgesic drugs were noted.

Registry
clinicaltrials.gov
Start Date
April 1, 2019
End Date
April 30, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Eskisehir Osmangazi University
Responsible Party
Principal Investigator
Principal Investigator

Tuba Tanyel

Medical Doctor, Research Assistant

Eskisehir Osmangazi University

Eligibility Criteria

Inclusion Criteria

  • Age 18-65;
  • ICHD-3 defined chronic migraine

Exclusion Criteria

  • Patients who had been started on an effective preventive medication within the past three months;
  • Medication-overuse headache;
  • Treatment with peripheral nerve blocks, trigger point injections or botulinum toxin injections within the past three months;
  • Known allergic reaction to local anaesthetics;
  • Pregnancy or nursing;
  • History of another headaches;
  • History of chronic medical conditions (e.g. cardiovascular, hepatic, renal, endocrine);
  • History of other chronic pain syndromes (e.g. low back pain and fibromyalgia).

Outcomes

Primary Outcomes

Visuel Analog Scale

Time Frame: 6 months

The lowest score on the visual analog scale is 0 and the highest score is 10. 10 indicates very severe pain, 0 indicates no pain

Study Sites (1)

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