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

Migraine Headaches Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02351544
• Other study ID #: 2015H0024
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: June 2022

Study information

• Verified date: April 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Headache
• Migraine Disorders
• Migraine Headaches

Intervention

Drug:
• Botulinum Toxin Type A

Procedure:
• Surgery

Other:
• Daily headache diary

• Migraine Disability Assessment Test (MIDAS)

• Migraine Work and Productivity Loss Questionnaire (MWPLQ)

• Migraine-Specific Quality of Life Questionnaire (MSQ)

Locations

Country	Name	City	State
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	Premier Plastic Surgery of Kansas City	Olathe	Kansas
United States	Neuropax Clinic	Saint Louis	Missouri
United States	Peled Plastic Surgery	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
Ohio State University	Massachusetts General Hospital, University Hospitals Cleveland Medical Center, University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migraine Headache Index (MHI) at 1 Year	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.	1 year postoperatively
Primary	Migraine Headache Index (MHI) at 2 Years	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.	2 years postoperatively
Primary	Migraine Headache Index (MHI) at 2.5 Years	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.	2.5 years postoperatively
Secondary	Migraine Disability Assessment Test (MIDAS) Score at 1 Year	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.	1 year postoperatively
Secondary	Migraine Disability Assessment Test (MIDAS) Score at 2 Years	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.	2 years postoperatively
Secondary	Migraine Disability Assessment Test (MIDAS) Score at 2.5 Years	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.	2.5 years postoperatively
Secondary	Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 1 Year	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	1 year postoperatively
Secondary	Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 2 Years	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	2 years postoperatively
Secondary	Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 2.5 Years	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	2.5 years postoperatively
Secondary	Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 1 Year	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.	1 year postoperatively
Secondary	Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 2 Years	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.	2 years postoperatively
Secondary	Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 2.5 Years	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.	2.5 years postoperatively