Prospective, Multi-Center Evaluation of the Efficacy of Peripheral Trigger Decompression Surgery for Migraine Headaches

Not Applicable

Completed

Conditions: Migraine Headaches

Interventions: Procedure: Surgery
Drug: Botulinum Toxin Type A
Other: Daily headache diary
Other: Migraine Disability Assessment Test (MIDAS)
Other: Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Other: Migraine-Specific Quality of Life Questionnaire (MSQ)

Registration Number: NCT02351544

Lead Sponsor: Ohio State University

Brief Summary: According to the peripheral trigger theory of migraine headaches, nociceptive inputs from irritated or compressed cranial nerve branches can lead to neurovascular changes in the brain that cause migraine headaches. Advanced treatments aimed at deactivating the peripheral trigger points can be administered to patients who have failed medical management of migraines. Those accepted advanced treatments include botulinum toxin A injection in order to temporarily paralyze muscles causing nerve compression, and surgery to release those compression points permanently. An advantage of surgery is the ability to release non-muscular causes of nerve compression, such as fascial bands or intersecting arteries.

Botulinum toxin A injection into trigger sites has been shown in multiple studies to be effective at reducing the frequency and severity of migraine headaches, and is a very commonly administered treatment for refractory migraines. It is approved by the FDA for the treatment of chronic migraines.

Similarly, surgical decompression of trigger sites has previously been shown to have superior clinical outcomes to medical management, through a randomized, blinded controlled-trial performed at Case Western Reserve in 2009. Patients either received actual decompression of the trigger sites, or sham surgery (exposure and visualization of the trigger sites, without decompression). At one-year follow-up, the group who underwent actual surgery demonstrated a statistically higher proportion with significant improvement in their migraines (83.7% vs. 57.7%, p=0.014), and with complete elimination of their migraines (57.1% vs. 3.8%, p\<0.001). Several other reports have confirmed the good clinical outcomes of surgery demonstrated in this trial, and surgical decompression is now commonly performed by several surgeons around the United States.

Prognostic factors predicting the success of surgical decompression in migraine headache treatment include older age of migraine onset, visual symptoms/aura, and 4-site decompression. Factors predicting failure of surgery include excessive operative blood loss, and surgery on only one or two trigger sites.

One criticism of the studies on peripheral trigger decompression surgery for migraines has been that most of the results have originated from the same institution (Case Western Reserve), and from the same author (Guyuron). While several studies at other institutions have demonstrated positive outcomes of peripheral trigger decompression, these have only included a small number of patients.

In addition, the sham surgery randomized-controlled trial has been criticized for not clarifying any prior treatments that patients had undergone before peripheral trigger deactivation, and for not showing how medication use patterns changed after surgery. Another criticism of that study was the fact that patients were examined by neurologists before the study but not after the study, and that surgery was performed on some patients with episodic migraines, who are known to not benefit from botulinum toxin. It is unclear what migraine types are most likely to benefit from surgical decompression.

The investigators' goal is to perform a multi-center, prospective trial to demonstrate the effectiveness of peripheral trigger decompression in the treatment of migraine headaches, which would address the criticisms mentioned above. The main aim is to demonstrate that the positive results demonstrated by Guyuron et al are reproducible at other institutions and by other surgeons using similar techniques on different patient populations.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 44

Inclusion Criteria

Patients with migraines related to a trigger site at the location of a branch of a cranial nerve (frontal, temporal, occipital)
Patients with chronic migraine (≥15 days per month) as dictated by the FDA indication for botulinum, and as diagnosed by a board-certified neurologist
Patients with episodic migraines
- Those patients are included because there is no consensus whether surgical decompression is effective for chronic migraines only, or for chronic and episodic migraines. One of the goals of this trial is to determine this.
Patients who respond to diagnostic botulinum toxin injection or to a diagnostic anesthetic block
Patients who have failed 2 of 3 classes of preventative migraine medications

Exclusion Criteria

Patients deemed by the authors or the neurologist to not have migraine headaches, but an alternative diagnosis
Patients with systemic conditions that make them poor candidates for surgery (coronary artery disease, uncontrolled diabetes mellitus, etc...)
Patients with migraines related to inferior turbinate hypertrophy or septal deviation
Patients with a frontal, temporal or occipital trigger point who do not respond to a diagnostic botulinum toxin injection or to a diagnostic anesthetic block
Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
Infection at the proposed injection site for botulinum
Patients with trigger points at minor trigger sites (lesser occipital nerve, third occipital nerve)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Botulinum toxin	Migraine-Specific Quality of Life Questionnaire (MSQ)	Patients in this arm will receive botulinum toxin for migraine headaches
Surgery	Surgery	Patients in this arm will receive surgery for migraine headaches
Surgery	Migraine Disability Assessment Test (MIDAS)	Patients in this arm will receive surgery for migraine headaches
Botulinum toxin	Migraine Work and Productivity Loss Questionnaire (MWPLQ)	Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum toxin	Daily headache diary	Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum toxin	Migraine Disability Assessment Test (MIDAS)	Patients in this arm will receive botulinum toxin for migraine headaches
Surgery	Migraine-Specific Quality of Life Questionnaire (MSQ)	Patients in this arm will receive surgery for migraine headaches
Surgery	Daily headache diary	Patients in this arm will receive surgery for migraine headaches
Surgery	Migraine Work and Productivity Loss Questionnaire (MWPLQ)	Patients in this arm will receive surgery for migraine headaches
Botulinum toxin	Botulinum Toxin Type A	Patients in this arm will receive botulinum toxin for migraine headaches

Primary Outcome Measures

Name	Time	Method
Migraine Headache Index (MHI) at 2.5 Years	2.5 years postoperatively	MHI is a numerical value calculated by multiplying the severity (1-10 numerical rating scale), duration (fraction of 24 h), and frequency (days per month) of migraine headaches. The lower the value the lower migraine severity reported is. The index range is minimum 0.00 to maximum 300.00.
Migraine Headache Index (MHI) at 1 Year	1 year postoperatively	MHI is a numerical value calculated by multiplying the severity (1-10 numerical rating scale), duration (fraction of 24 h), and frequency (days per month) of migraine headaches. The lower the value the lower migraine severity reported is. The index range is minimum 0.00 to maximum 300.00.
Migraine Headache Index (MHI) at 2 Years	2 years postoperatively	MHI is a numerical value calculated by multiplying the severity (1-10 numerical rating scale), duration (fraction of 24 h), and frequency (days per month) of migraine headaches. The lower the value the lower migraine severity reported is. The index range is minimum 0.00 to maximum 300.00.

Secondary Outcome Measures

Name	Time	Method
Migraine Disability Assessment Test (MIDAS) Score at 1 Year	1 year postoperatively	MIDAS questionnaire was developed to quantify the effect of headaches on patients' daily functionality in the past 3 months. It consists of five questions related to paid work or school, household work, and leisure time. A total score of 0-5 corresponds to little or no disability, 6-10 points refers to mild disability, 11-20 points mean moderate disability, and more than 21 points represent severe disability (MIDAS total). For MIDAS total, the higher the numeric response, the greater the overall impact of MH. The minimum score is 0.00 and the maximum score is 90.00.
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 1 Year	1 year postoperatively	MSQ is a 14-item questionnaire that evaluates the long-term perceived impact of MH on health-related quality of life over the past 4 weeks. Responses per item include a 6-point scale: 'none of the time,' 'a little bit of the time,' 'some of the time,' 'a good bit of the time,' 'most of the time,' and 'all of the time.' Each option is assigned a score of 1 to 6, respectively. Each domain is scored independently as a sum of items and rescaled from a 0 to 100 scale, with higher scores indicating better quality of life. MSQ survey was analyzed in totality. A higher MSQ sum reflects patient improvement in quality of life. The minimum is 0.00 and the maximum is 270.00.
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 2 Years	2 years postoperatively	MSQ is a 14-item questionnaire that evaluates the long-term perceived impact of MH on health-related quality of life over the past 4 weeks. Responses per item include a 6-point scale: 'none of the time,' 'a little bit of the time,' 'some of the time,' 'a good bit of the time,' 'most of the time,' and 'all of the time.' Each option is assigned a score of 1 to 6, respectively. Each domain is scored independently as a sum of items and rescaled from a 0 to 100 scale, with higher scores indicating better quality of life. MSQ survey was analyzed in totality. A higher MSQ sum reflects patient improvement in quality of life. The minimum is 0.00 and the maximum is 270.00.
Migraine Disability Assessment Test (MIDAS) Score at 2.5 Years	2.5 years postoperatively	MIDAS questionnaire was developed to quantify the effect of headaches on patients' daily functionality in the past 3 months. It consists of five questions related to paid work or school, household work, and leisure time. A total score of 0-5 corresponds to little or no disability, 6-10 points refers to mild disability, 11-20 points mean moderate disability, and more than 21 points represent severe disability (MIDAS total). For MIDAS total, the higher the numeric response, the greater the overall impact of MH. The minimum score is 0.00 and the maximum score is 90.00.
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 1 Year	1 year postoperatively	MWPLQ has nine questions that evaluate the impact of migraine and migraine therapy on paid work and productivity loss. Question #7 from the MWPLQ (MWPLQ7) was the most frequently and consistently answered with meaningful responses and did not depend on questions #1-6, 8-9. Therefore, MWPLQ7 was analyzed independently, and the remaining questions were not included in the final analysis. Question #7 assesses the difficulty of 18 work-related activities caused by the most recent MH or migraine headache treatment. Each item in question 7 has the following options: 0 ('no difficulty'), 1 ('a slight amount'), 2 ('some'), 3 ('quite a bit'), 4 ('a great deal'), 5 ('so much difficulty, could not do at all'), and 6 ('does not apply to my work'). To quantify difficulty, a total sum score of these 18 items including only options 0 to 5 is obtained. A higher MWPLQ7 summed score reveals a higher (worse) effect of MH on work and productivity. The minimum is 0.00 and the maximum is 90.00
Migraine Disability Assessment Test (MIDAS) Score at 2 Years	2 years postoperatively	MIDAS questionnaire was developed to quantify the effect of headaches on patients' daily functionality in the past 3 months. It consists of five questions related to paid work or school, household work, and leisure time. A total score of 0-5 corresponds to little or no disability, 6-10 points refers to mild disability, 11-20 points mean moderate disability, and more than 21 points represent severe disability (MIDAS total). For MIDAS total, the higher the numeric response, the greater the overall impact of MH. The minimum score is 0.00 and the maximum score is 90.00.
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 2 Years	2 years postoperatively	MWPLQ has nine questions that evaluate the impact of migraine and migraine therapy on paid work and productivity loss. Question #7 from the MWPLQ (MWPLQ7) was the most frequently and consistently answered with meaningful responses and did not depend on questions #1-6, 8-9. Therefore, MWPLQ7 was analyzed independently, and the remaining questions were not included in the final analysis. Question #7 assesses the difficulty of 18 work-related activities caused by the most recent MH or migraine headache treatment. Each item in question 7 has the following options: 0 ('no difficulty'), 1 ('a slight amount'), 2 ('some'), 3 ('quite a bit'), 4 ('a great deal'), 5 ('so much difficulty, could not do at all'), and 6 ('does not apply to my work'). To quantify difficulty, a total sum score of these 18 items including only options 0 to 5 is obtained. A higher MWPLQ7 summed score reveals a higher (worse) effect of MH on work and productivity. The minimum is 0.00 and the maximum is 90.00
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 2.5 Years	2.5 years postoperatively	MWPLQ has nine questions that evaluate the impact of migraine and migraine therapy on paid work and productivity loss. Question #7 from the MWPLQ (MWPLQ7) was the most frequently and consistently answered with meaningful responses and did not depend on questions #1-6, 8-9. Therefore, MWPLQ7 was analyzed independently, and the remaining questions were not included in the final analysis. Question #7 assesses the difficulty of 18 work-related activities caused by the most recent MH or migraine headache treatment. Each item in question 7 has the following options: 0 ('no difficulty'), 1 ('a slight amount'), 2 ('some'), 3 ('quite a bit'), 4 ('a great deal'), 5 ('so much difficulty, could not do at all'), and 6 ('does not apply to my work'). To quantify difficulty, a total sum score of these 18 items including only options 0 to 5 is obtained. A higher MWPLQ7 summed score reveals a higher (worse) effect of MH on work and productivity. The minimum is 0.00 and the maximum is 90.00
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 2.5 Years	2.5 years postoperatively	MSQ is a 14-item questionnaire that evaluates the long-term perceived impact of MH on health-related quality of life over the past 4 weeks. Responses per item include a 6-point scale: 'none of the time,' 'a little bit of the time,' 'some of the time,' 'a good bit of the time,' 'most of the time,' and 'all of the time.' Each option is assigned a score of 1 to 6, respectively. Each domain is scored independently as a sum of items and rescaled from a 0 to 100 scale, with higher scores indicating better quality of life. MSQ survey was analyzed in totality. A higher MSQ sum reflects patient improvement in quality of life. The minimum is 0.00 and the maximum is 270.00.

Trial Locations

Locations (6): Neuropax Clinic
🇺🇸
Saint Louis, Missouri, United States
Premier Plastic Surgery of Kansas City
🇺🇸
Olathe, Kansas, United States
Peled Plastic Surgery
🇺🇸
San Francisco, California, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
The Ohio State University Wexner Medical Center
🇺🇸
Columbus, Ohio, United States
The University of Wisconsin-Madison
🇺🇸
Madison, Wisconsin, United States