Trial Outcomes & Findings for Prospective, Multi-Center Evaluation of the Efficacy of Peripheral Trigger Decompression Surgery for Migraine Headaches (NCT NCT02351544)
NCT ID: NCT02351544
Last Updated: 2024-04-22
Results Overview
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.
COMPLETED
NA
44 participants
1 year postoperatively
2024-04-22
Participant Flow
Participant milestones
| Measure |
Botulinum Toxin
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
33
|
|
Overall Study
COMPLETED
|
11
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Botulinum Toxin
n=11 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=33 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=44 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=11 Participants
|
33 Participants
n=33 Participants
|
44 Participants
n=44 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=44 Participants
|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 14.3 • n=11 Participants
|
43.8 years
STANDARD_DEVIATION 12.7 • n=33 Participants
|
43 years
STANDARD_DEVIATION 13.2 • n=44 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=11 Participants
|
29 Participants
n=33 Participants
|
39 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=11 Participants
|
4 Participants
n=33 Participants
|
5 Participants
n=44 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
11 participants
n=11 Participants
|
33 participants
n=33 Participants
|
44 participants
n=44 Participants
|
PRIMARY outcome
Timeframe: 1 year postoperativelyPopulation: Patients enrolled and analyzed in each group for this outcome measure.
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.
Outcome measures
| Measure |
Botulinum Toxin
n=11 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=12 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Headache Index (MHI) at 1 Year
|
7.81 index score
Interval 2.44 to 21.53
|
3.73 index score
Interval 0.94 to 10.53
|
PRIMARY outcome
Timeframe: 2 years postoperativelyPopulation: patients enrolled and analyzed in each group for this outcome measure.
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.
Outcome measures
| Measure |
Botulinum Toxin
n=10 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=10 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Headache Index (MHI) at 2 Years
|
61.12 index score
Interval 34.23 to 108.53
|
5.54 index score
Interval 1.52 to 15.94
|
PRIMARY outcome
Timeframe: 2.5 years postoperativelyPopulation: participants and enrolled and analyzed for this outcome measure
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.
Outcome measures
| Measure |
Botulinum Toxin
n=3 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=2 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Headache Index (MHI) at 2.5 Years
|
8.74 index score
Interval 2.69 to 24.72
|
1.28 index score
Interval 0.0 to 13.7
|
SECONDARY outcome
Timeframe: 1 year postoperativelyPopulation: participants enrolled and analyzed in this outcome measure at this time point
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.
Outcome measures
| Measure |
Botulinum Toxin
n=11 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=28 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Disability Assessment Test (MIDAS) Score at 1 Year
|
17.05 units on a scale
Interval 6.27 to 43.82
|
8.84 units on a scale
Interval 4.62 to 16.22
|
SECONDARY outcome
Timeframe: 2 years postoperativelyPopulation: participants enrolled and analyzed for this outcome at this timepoint
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.
Outcome measures
| Measure |
Botulinum Toxin
n=10 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=24 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Disability Assessment Test (MIDAS) Score at 2 Years
|
10.84 units on a scale
Interval 3.62 to 29.33
|
7.60 units on a scale
Interval 3.76 to 14.54
|
SECONDARY outcome
Timeframe: 2.5 years postoperativelyPopulation: participants enrolled and analyzed in the outcome measure at the timepoint
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.
Outcome measures
| Measure |
Botulinum Toxin
n=3 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=10 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Disability Assessment Test (MIDAS) Score at 2.5 Years
|
10.25 units on a scale
Interval 1.48 to 50.08
|
10.55 units on a scale
Interval 3.98 to 25.79
|
SECONDARY outcome
Timeframe: 1 year postoperativelyPopulation: participants enrolled and analyzed for this outcome measure at this timepoint
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
Outcome measures
| Measure |
Botulinum Toxin
n=10 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=16 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 1 Year
|
40.44 units on a scale
Interval 20.73 to 78.03
|
16.03 units on a scale
Interval 9.34 to 27.06
|
SECONDARY outcome
Timeframe: 2 years postoperativelyPopulation: participants enrolled and analyzed for this outcome measure at this timepoint
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
Outcome measures
| Measure |
Botulinum Toxin
n=9 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=11 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 2 Years
|
34.68 units on a scale
Interval 17.21 to 68.87
|
7.63 units on a scale
Interval 3.82 to 14.41
|
SECONDARY outcome
Timeframe: 2.5 years postoperativelyPopulation: participants enrolled and analyzed for this outcome measure during this timepoint
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
Outcome measures
| Measure |
Botulinum Toxin
n=3 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=7 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine Work and Productivity Loss Questionnaire (MMWPLQ) Score at 2.5 Years
|
26.62 units on a scale
Interval 8.55 to 78.91
|
9.79 units on a scale
Interval 4.3 to 20.99
|
SECONDARY outcome
Timeframe: 1 year postoperativelyPopulation: participants enrolled and analyzed during this timepoint for this outcome
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.
Outcome measures
| Measure |
Botulinum Toxin
n=11 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=30 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 1 Year
|
55.05 units on a scale
Interval 31.62 to 95.3
|
60.61 units on a scale
Interval 43.41 to 84.47
|
SECONDARY outcome
Timeframe: 2 years postoperativelyPopulation: participants enrolled and analyzed for this outcome measure at this timepoint
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.
Outcome measures
| Measure |
Botulinum Toxin
n=10 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=26 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 2 Years
|
61.12 units on a scale
Interval 34.23 to 108.53
|
43.42 units on a scale
Interval 30.27 to 62.1
|
SECONDARY outcome
Timeframe: 2.5 years postoperativelyPopulation: participants enrolled and analyzed at this outcome measure at this timepoint
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.
Outcome measures
| Measure |
Botulinum Toxin
n=3 Participants
Patients in this arm will receive botulinum toxin for migraine headaches
Botulinum Toxin Type A
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
Surgery
n=13 Participants
Patients in this arm will receive surgery for migraine headaches
Surgery
Daily headache diary
Migraine Disability Assessment Test (MIDAS)
Migraine Work and Productivity Loss Questionnaire (MWPLQ)
Migraine-Specific Quality of Life Questionnaire (MSQ)
|
|---|---|---|
|
Migraine-Specific Quality of Life Questionnaire (MSQ) Score at 2.5 Years
|
74.30 units on a scale
Interval 26.08 to 208.37
|
37.73 units on a scale
Interval 22.66 to 62.4
|
Adverse Events
Botulinum Toxin
Surgery
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place