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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Visuel Analog Scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Tuba Tanyel
Medical Doctor, Research Assistant
Eskisehir Osmangazi University