Nerve Blocks for Post-Traumatic Headache
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two nerve block treatments for headaches caused by head injuries, such as concussions. The goal is to determine if these treatments, involving injections in the neck and head, can reduce headache pain. It may be suitable for individuals who have experienced head injury-related headaches within the last year and have not found relief from other treatments. Participants will receive either an occipital nerve block (ONB) or a cervical medial branch block (CMBB) to evaluate which is more effective at reducing pain. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators for more details.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that both cervical medial branch block (CMBB) and occipital nerve block (ONB) are generally safe and well-tolerated. Studies on CMBB indicate that complications are rare, and most patients handle it well. Like any injection, it can cause temporary side effects, such as soreness at the injection site.
For ONB, studies also find it to be generally well-tolerated. Some people might experience mild side effects, like numbness or tingling at the injection site, but these usually don't last long.
Both treatments have been used successfully to manage pain, providing evidence that they can be safe options when performed under medical supervision.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using nerve blocks for post-traumatic headaches because they provide a targeted approach that directly addresses the pain at its source. Unlike traditional pain medications that can take time to work and may cause systemic side effects, nerve blocks offer immediate relief by delivering anti-inflammatory and numbing agents directly to the affected nerves in the head and neck. This method not only helps in reducing pain quickly but also minimizes overall medication use and potential side effects. Additionally, the potential for long-term pain management with fewer treatments is a promising advancement over conventional therapies.
What evidence suggests that this trial's treatments could be effective for post-traumatic headache?
This trial will compare the effectiveness of cervical medial branch blocks (CMBB) and occipital nerve blocks (ONB) for post-traumatic headaches. Research has shown that CMBB can effectively reduce headaches, with studies indicating that people with severe headaches experience both quick and long-lasting relief after these treatments. In one study, patients reported at least 50% less pain after receiving CMBB. ONB is another treatment option in this trial, and studies suggest it is also promising. In one study, some patients experienced complete relief from headaches, with an average pain reduction of 88%. Another study found that ONB led to fewer headaches over time. Both CMBB and ONB treatments offer hope for those suffering from post-traumatic headaches.56789
Are You a Good Fit for This Trial?
This trial is for adolescents and adults aged 14-45 who suffer from headaches or neck pain after a head injury in the past year. Participants must have tried at least one treatment without success, such as migraine prevention meds, neuropathic pain meds, physical therapy, or cognitive-behavioral therapy. Those with significant psychological issues or unable to consent are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either an occipital nerve block or a cervical medial branch block. If a >50% pain reduction is observed after four weeks, they may continue to receive blocks as needed, but not more than one every three months.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments of headache severity, frequency, and quality of life.
What Are the Treatments Tested in This Trial?
Interventions
- Cervical Medial Branch Block (CMBB)
- Occipital Nerve Block (ONB)
Trial Overview
The study tests two procedures: Cervical Medial Branch Block (CMBB) and Occipital Nerve Block (ONB), both using lidocaine and dexamethasone to manage post-traumatic headaches. It's a randomized controlled trial comparing these invasive treatments' effectiveness against standard conservative care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months. If patients exhibit \< 50% pain reduction, the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
After enrollment in the study, patients will be randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. These are injections of anti-inflammatory medications (steroids) and numbing medications (local anesthetics -lidocaine) in nerves located at the back of the head and neck. If patients exhibit a \> or = 50% pain reduction on receiving the block evaluated after four weeks, then they may continue to receive blocks as needed, but not more than one every three months. If patients exhibit \< 50% pain reduction the patient will be treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
Harvard University
Collaborator
Beth Israel Deaconess Medical Center
Collaborator
Citations
A Systematic Review and Meta-analysis of the Effectiveness of ...
In this study with the main outcome being NRS, significant improvement was defined as at least 50% improvement in pain relief. In this study, ...
The Clinical Effects of C2 and C3 Medial Branch Block for ...
This study demonstrates clinical effectiveness of C2/3 MBB in patients with medically intractable headaches, with both early and prolonged benefits.
Efficacy of Nerve Blocks for Managing Refractory ...
Conclusion: This retrospective review offers preliminary but compelling evidence that nerve blocks are a highly effective option for patients with posttraumatic ...
The Clinical Effects of C2 and C3 Medial Branch Block for ...
Conclusion : This study demonstrates clinical effectiveness of C2/3 MBB in patients with medically intractable headaches, with both early and prolonged benefits ...
Effectiveness of Cervical Medial Branch Thermal ...
Outcome data showed a greater degree of pain relief more often when patients ... medial branch block; cervicogenic headache. Issue Section: SPINE SECTION ...
Prospective evaluation of the safety of ultrasound-guided ...
Cervical medial branch block: a novel technique using ultrasound guidance. ... Comparative outcomes of a 2-year follow-up of cervical medial branch blocks ...
Evidence-based cervical facet consensus: access or ...
While studies show robust outcomes using parallel multisite and mutilesions with 18 or larger gauge radiofrequency needles or an equivalent ...
Dropped head syndrome after bilateral cervical ...
Cervical medial branch radiofrequency ablation is an effective treatment for cervical facet joint pain. It is considered a safe procedure, and permanent ...
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researchgate.net
researchgate.net/publication/330040587_Postdural_Puncture_Headache_after_Cervical_Medial_Branch_BlockPostdural Puncture Headache after Cervical Medial Branch ...
Cervical medial branch block (MBB) is a frequently performed procedure for management of neck pain that rarely has complica-.
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