Trial Outcomes & Findings for A Prospective Controlled Treatment Trial for Post-Traumatic Headaches (NCT NCT03007420)
NCT ID: NCT03007420
Last Updated: 2025-10-14
Results Overview
Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
16 participants
Primary outcome timeframe
One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure
Results posted on
2025-10-14
Participant Flow
Patients were recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center. Eligibility Criteria included: * Age 14 - 45 years. * History of post-traumatic headache or neck pain following a concussion or head injury within the last 2 years. * Self-reported lack of meaningful benefit with at least one previous treatment trial.
Participant milestones
| Measure |
Occipital Nerve Block
After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.
If patients exhibited \< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
|
Cervical Medial Branch Block
After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.
If patients exhibited \< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
|
Overall Study
Crossover
|
3
|
2
|
|
Overall Study
COMPLETED
|
8
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Occipital Nerve Block
After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.
If patients exhibited \< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
|
Cervical Medial Branch Block
After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.
If patients exhibited \< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Physician Decision
|
0
|
1
|
Baseline Characteristics
A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
Baseline characteristics by cohort
| Measure |
Occipital Nerve Block
n=8 Participants
After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.
If patients exhibited \< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
|
Cervical Medial Branch Block
n=8 Participants
After enrollment in the study, patients were randomized (but not blinded) to receive either an occipital nerve block or a cervical medial branch block. If patients exhibited a \> or = 50% pain reduction on receiving the block evaluated after four weeks, they had an option to continue receiving blocks as needed, but not more than one every three months.
If patients exhibited \< 50% pain reduction, they were treated as per the clinician's judgment with the possibility of a cross over to the other treatment option.
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23 years
STANDARD_DEVIATION 6 • n=5 Participants
|
21 years
STANDARD_DEVIATION 7 • n=7 Participants
|
22 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Pain Score at Baseline
|
3.8 units on a scale
n=5 Participants
|
4.9 units on a scale
n=7 Participants
|
4.6 units on a scale
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedurePopulation: 16 patients provided baseline pain score data that has been presented in the Baseline Demographics section. Post-procedure pain scores have been reported below.
Pain intensity was rated using the Numerical Rating Scale (NRS) of 0 to 10, with 0 indicating 'no pain' and 10 indicating the 'worst pain imaginable'.
Outcome measures
| Measure |
Cervical Medial Branch Block
n=7 Participants
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.
|
Occipital Nerve Block
n=8 Participants
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.
|
|---|---|---|
|
Pain Score
Numerical Rating Scale at 1 week post procedure timepoint
|
3.7 units on a scale
Interval 1.5 to 4.5
|
2.9 units on a scale
Interval 1.5 to 4.7
|
|
Pain Score
Numerical Rating Scale at 1 month post procedure time point
|
1.6 units on a scale
Interval 1.0 to 3.3
|
1 units on a scale
Interval 0.4 to 2.4
|
|
Pain Score
Numerical Rating Scale at 2 months post procedure time point
|
5.2 units on a scale
Interval 2.0 to 5.5
|
2.3 units on a scale
Interval 1.3 to 4.6
|
|
Pain Score
Numerical Rating Scale at 3 months post procedure time
|
1.7 units on a scale
Interval 0.0 to 3.5
|
2.1 units on a scale
Interval 1.2 to 3.0
|
|
Pain Score
Numerical Rating Scale at 6 months post procedure time
|
0.8 units on a scale
Interval 0.4 to 2.9
|
1.8 units on a scale
Interval 1.0 to 4.0
|
|
Pain Score
Numerical Rating Scale at 9 months post procedure time
|
3.6 units on a scale
Interval 2.6 to 4.5
|
0 units on a scale
Interval 0.0 to 3.5
|
|
Pain Score
Numerical Rating Scale at 12 months post procedure time
|
3.4 units on a scale
Interval 3.0 to 3.9
|
0.5 units on a scale
Interval 0.3 to 0.6
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: The Migraine Disability Assessment (MIDAS) is validated for patients 18 years and older only.
The Migraine Disability Assessment (MIDAS) is a self-administered standardized questionnaire to quantify headache-related disability. The MIDAS score ranges from 0 to 270. The higher the score on the MIDAS questionnaire, the greater the disability caused by headaches.
Outcome measures
| Measure |
Cervical Medial Branch Block
n=5 Participants
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.
|
Occipital Nerve Block
n=5 Participants
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.
|
|---|---|---|
|
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)
MIDAS Score at Baseline
|
159 units on a scale
Interval 55.0 to 168.0
|
85 units on a scale
Interval 53.0 to 94.0
|
|
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)
MIDAS Score at 3 months
|
43 units on a scale
Interval 26.0 to 49.5
|
16 units on a scale
Interval 12.0 to 59.5
|
|
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)
MIDAS Score at 6 months
|
5 units on a scale
Interval 2.5 to 18.5
|
96 units on a scale
Interval 68.0 to 124.0
|
|
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)
MIDAS Score at 9 months
|
60 units on a scale
Interval 60.0 to 60.0
|
26.5 units on a scale
Interval 26.5 to 26.75
|
|
Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS)
MIDAS Score at 12 months
|
39 units on a scale
Interval 39.0 to 39.0
|
9 units on a scale
Interval 4.5 to 13.5
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: PedsMIDAS is only validated for patients for patients under the age of 18 years.
The Pediatric Migraine Disability Assessment (PedsMIDAS) is a self-administered standardized questionnaire to quantify headache related disability. The PedsMIDAS score ranges from 0 to 240. The higher the score on the PedsMIDAS questionnaire, the greater the disability caused by headaches.
Outcome measures
| Measure |
Cervical Medial Branch Block
n=3 Participants
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.
|
Occipital Nerve Block
n=3 Participants
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.
|
|---|---|---|
|
Pediatric Migraine Disability Assessment (PedMIDAS)
PedsMIDAS at Baseline
|
70 units on a scale
Interval 42.0 to 151.5
|
227 units on a scale
Interval 205.0 to 248.0
|
|
Pediatric Migraine Disability Assessment (PedMIDAS)
PedsMIDAS at 3 months
|
217 units on a scale
Interval 217.0 to 217.0
|
23 units on a scale
Interval 11.5 to 88.5
|
|
Pediatric Migraine Disability Assessment (PedMIDAS)
PedsMIDAS at 6 months
|
—
|
16 units on a scale
Interval 8.0 to 75.0
|
|
Pediatric Migraine Disability Assessment (PedMIDAS)
PedsMIDAS at 9 months
|
67 units on a scale
Interval 67.0 to 67.0
|
9 units on a scale
Interval 4.5 to 72.0
|
|
Pediatric Migraine Disability Assessment (PedMIDAS)
PedsMIDAS at 12 months
|
68 units on a scale
Interval 68.0 to 68.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: The Migraine Disability Assessment (MIDAS) is validated for patients 18 years and older only.
Self-administered questionnaire to quantify headache-severity using the following question: On a scale of 0 - 10, on average how painful were these headaches? (where 0=no pain at all, and 10=pain as bad as it can be)
Outcome measures
| Measure |
Cervical Medial Branch Block
n=5 Participants
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.
|
Occipital Nerve Block
n=5 Participants
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.
|
|---|---|---|
|
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)
MIDAS severity at baseline
|
6 units on a scale
Interval 4.0 to 7.0
|
6 units on a scale
Interval 5.0 to 7.0
|
|
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)
MIDAS severity at 3 months
|
3 units on a scale
Interval 2.5 to 4.0
|
3 units on a scale
Interval 3.0 to 4.0
|
|
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)
MIDAS severity at 6 months
|
4 units on a scale
Interval 3.0 to 4.5
|
4.5 units on a scale
Interval 3.25 to 5.75
|
|
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)
MIDAS severity at 9 months
|
6 units on a scale
Interval 6.0 to 6.0
|
4 units on a scale
Interval 3.0 to 5.0
|
|
Headache Severity Assessed by Migraine Disability Assessment (MIDAS)
MIDAS severity at 12 months
|
4 units on a scale
Interval 4.0 to 4.0
|
1 units on a scale
Interval 0.5 to 1.5
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: Although the investigators initially intended to assess headache severity using the PedsMIDAS questionnaire, it was discovered the specific headache severity assessment question was not included in the validated PedsMIDAS questionnaire. Consequently, we are unable to report data for this measure. Other alternate measures are reported. This was identified and reported as a minor deviation.
Self-administered questionnaire to quantify headache-related disability
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: The FDI is validated in patients under the age 18 years.
The Functional Disability Inventory (FDI) was used to assess functional disability. The FDI is scored by summing the ratings for each of its 15 items, with scores ranging from 0 to 60. Higher scores indicate greater perceived functional disability.
Outcome measures
| Measure |
Cervical Medial Branch Block
n=3 Participants
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.
|
Occipital Nerve Block
n=3 Participants
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.
|
|---|---|---|
|
Functional Disability Inventory Scores (FDI)
FDI Score at Baseline
|
18 units on a scale
Interval 11.0 to 26.5
|
9 units on a scale
Interval 9.0 to 18.5
|
|
Functional Disability Inventory Scores (FDI)
FDI Score at 3 months
|
30 units on a scale
Interval 30.0 to 30.0
|
11 units on a scale
Interval 5.5 to 19.5
|
|
Functional Disability Inventory Scores (FDI)
FDI Score at 6 months
|
—
|
17 units on a scale
Interval 8.5 to 22.0
|
|
Functional Disability Inventory Scores (FDI)
FDI Score at 9 months
|
14 units on a scale
Interval 14.0 to 14.0
|
10 units on a scale
Interval 5.0 to 16.0
|
|
Functional Disability Inventory Scores (FDI)
FDI Score at 12 months
|
4 units on a scale
Interval 4.0 to 4.0
|
0 units on a scale
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, 3 months, 6 months, 9 months, 12 monthsPopulation: The PDI is validated in patients 18 years of age or older.
The Pain Disability Index (PDI) was used to assess functional disability in adults. The PDI is scored by summing the ratings of seven different life domains, each scored on a scale of 0 to 10, with higher scores indicating greater pain-related disability. The total score can range from 0 to 70. A higher score reflects a greater impact of pain on daily activities.
Outcome measures
| Measure |
Cervical Medial Branch Block
n=5 Participants
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.
|
Occipital Nerve Block
n=5 Participants
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.
|
|---|---|---|
|
Pain Disability Index (PDI)
PDI Score at Baseline
|
36 units on a scale
Interval 11.0 to 37.0
|
30 units on a scale
Interval 29.0 to 33.0
|
|
Pain Disability Index (PDI)
PDI Score at 3 months
|
0 units on a scale
Interval 0.0 to 7.5
|
19 units on a scale
Interval 13.5 to 22.0
|
|
Pain Disability Index (PDI)
PDI Score at 6 months
|
0 units on a scale
Interval 0.0 to 11.0
|
16 units on a scale
Interval 10.5 to 21.5
|
|
Pain Disability Index (PDI)
PDI Score at 9 months
|
13 units on a scale
Interval 13.0 to 13.0
|
2.5 units on a scale
Interval 1.25 to 3.75
|
|
Pain Disability Index (PDI)
PDI Score at 12 months
|
10 units on a scale
Interval 10.0 to 10.0
|
6 units on a scale
Interval 5.5 to 6.5
|
SECONDARY outcome
Timeframe: Baseline, 2 months, 3 months, 6 months, 9 months, 12 monthsPopulation: WHOQOL-BREF is validated in adults 18 years of age or older.
The WHOQOL-BREF produces four domain scores (Physical health, Psychological, Social Relationships, and Environment) and two overall items (overall quality of life and general health). The scores range from 4-20 with higher scores indicating a better quality of life.
Outcome measures
| Measure |
Cervical Medial Branch Block
n=5 Participants
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.
|
Occipital Nerve Block
n=5 Participants
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.
|
|---|---|---|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Environment Scores at 12 months
|
16 units on a scale
Interval 16.0 to 16.0
|
16 units on a scale
Interval 15.8 to 16.3
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Physical Health Scores at Baseline
|
12 units on a scale
Interval 10.9 to 13.7
|
10.9 units on a scale
Interval 9.7 to 11.4
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Psychological Health Scores at Baseline
|
14 units on a scale
Interval 12.0 to 15.3
|
11.3 units on a scale
Interval 10.7 to 12.0
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Social Relationship Scores at Baseline
|
14.7 units on a scale
Interval 14.7 to 16.0
|
14.7 units on a scale
Interval 12.0 to 16.0
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Environment Scores at Baseline
|
15.3 units on a scale
Interval 15.0 to 16.0
|
15.5 units on a scale
Interval 15.5 to 16.5
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Physical Health Scores at 2 months
|
12.6 units on a scale
Interval 11.7 to 13.9
|
12.6 units on a scale
Interval 12.6 to 12.9
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Psychological Health Scores at 2 months
|
13.3 units on a scale
Interval 11.7 to 14.7
|
12 units on a scale
Interval 10.7 to 12.7
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Social Relationships Scores at 2 months
|
13.3 units on a scale
Interval 13.0 to 15.0
|
16 units on a scale
Interval 15.3 to 16.0
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Environment Scores at 2 months
|
16 units on a scale
Interval 14.9 to 17.4
|
15.5 units on a scale
Interval 15.0 to 15.8
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Physical Health Scores at 3 months
|
13.7 units on a scale
Interval 12.9 to 14.6
|
13.1 units on a scale
Interval 12.9 to 13.1
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
HOQOL-BREF Psychological Health Scores at 3 months
|
15 units on a scale
Interval 13.8 to 16.2
|
12.7 units on a scale
Interval 12.7 to 12.7
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Social Relationship Scores at 3 months
|
16 units on a scale
Interval 14.0 to 18.0
|
16 units on a scale
Interval 14.7 to 16.7
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Environment Scores at 3 months
|
18 units on a scale
Interval 17.0 to 19.0
|
15.5 units on a scale
Interval 15.0 to 16.8
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Physical Health Scores at 6 months
|
13.1 units on a scale
Interval 12.9 to 14.0
|
12 units on a scale
Interval 11.4 to 12.6
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Psychological Health Scores at 6 months
|
14.7 units on a scale
Interval 13.3 to 16.0
|
13 units on a scale
Interval 12.8 to 13.7
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Social Relationship Scores at 6 months
|
16.5 units on a scale
Interval 16.3 to 17.8
|
14.7 units on a scale
Interval 14.7 to 14.7
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Environment Scores at 6 months
|
16.5 units on a scale
Interval 16.3 to 17.8
|
15.5 units on a scale
Interval 15.3 to 15.8
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Physical Health Scores at 9 months
|
12.6 units on a scale
Interval 12.6 to 12.6
|
12.9 units on a scale
Interval 12.1 to 13.6
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Psychological Health Scores at 9 months
|
12 units on a scale
Interval 12.0 to 12.0
|
15 units on a scale
Interval 14.8 to 15.2
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Social Relationship Scores at 9 months
|
16 units on a scale
Interval 16.0 to 16.0
|
—
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Environment Scores at 9 months
|
16 units on a scale
Interval 16.0 to 16.0
|
16.3 units on a scale
Interval 15.9 to 16.6
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Physical Health Scores at 12 months
|
12 units on a scale
Interval 12.0 to 12.0
|
14.6 units on a scale
Interval 14.4 to 14.7
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Psychological Health Scores at 12 months
|
11.3 units on a scale
Interval 11.3 to 11.3
|
15.3 units on a scale
Interval 14.7 to 16.0
|
|
World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF)
WHOQOL-BREF Social Relationship Scores at 12 months
|
14.7 units on a scale
Interval 14.7 to 14.7
|
14.7 units on a scale
Interval 14.0 to 15.3
|
SECONDARY outcome
Timeframe: Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedurePopulation: The PEDsQL assessment is validated in patients under the age 18 years.
The Pediatric Quality of Life Assessment (PedsQL) is a standardized questionnaire that assesses a pediatric patient's perceptions of health-related quality of life (HRQOL) with chronic health conditions using 4 domains (Physical, Emotional, Social, School Functioning). PedsQL scores range from 0-100 where higher scores indicate better health-related quality of life.
Outcome measures
| Measure |
Cervical Medial Branch Block
n=3 Participants
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.
|
Occipital Nerve Block
n=3 Participants
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.
|
|---|---|---|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Physical Functioning at Baseline
|
43.6 units on a scale
Interval 40.6 to 68.8
|
53.1 units on a scale
Interval 53.1 to 70.3
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Emotional Functioning at Baseline
|
65 units on a scale
Interval 60.0 to 82.5
|
75 units on a scale
Interval 67.5 to 77.5
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Social Functioning at Baseline
|
80 units on a scale
Interval 67.5 to 90.0
|
100 units on a scale
Interval 82.5 to 100.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL School Functioning at Baseline
|
55 units on a scale
Interval 42.5 to 65.0
|
35 units on a scale
Interval 30.0 to 50.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Physical Functioning at 2 months
|
34.4 units on a scale
Interval 34.4 to 34.4
|
68.6 units on a scale
Interval 68.6 to 68.6
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Emotional Functioning at 2 months
|
90 units on a scale
Interval 90.0 to 90.0
|
85 units on a scale
Interval 85.0 to 85.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Social Functioning at 2 months
|
70 units on a scale
Interval 70.0 to 70.0
|
95 units on a scale
Interval 95.0 to 95.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL School Functioning at 2 months
|
30 units on a scale
Interval 30.0 to 30.0
|
35 units on a scale
Interval 35.0 to
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Physical Functioning at 3 months
|
40.6 units on a scale
Interval 40.6 to 40.6
|
62.5 units on a scale
Interval 57.8 to 81.3
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Emotional Functioning at 3 months
|
65 units on a scale
Interval 65.0 to 65.0
|
85 units on a scale
Interval 85.0 to 85.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Social Functioning at 3 months
|
60 units on a scale
Interval 60.0 to 60.0
|
90 units on a scale
Interval 85.0 to 95.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL School Functioning at 3 months
|
40 units on a scale
Interval 40.0 to 40.0
|
50 units on a scale
Interval 37.5 to 72.5
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Physical Functioning at 6 months
|
—
|
65.6 units on a scale
Interval 50.0 to 82.8
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Emotional Functioning at 6 months
|
—
|
75 units on a scale
Interval 72.5 to 87.5
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Social Functioning at 6 months
|
—
|
100 units on a scale
Interval 95.0 to 100.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Sleep Functioning at 6 months
|
—
|
50 units on a scale
Interval 47.5 to 75.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Physical Functioning at 9 months
|
65.6 units on a scale
Interval 65.6 to 65.6
|
65.6 units on a scale
Interval 64.1 to 82.8
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Emotional Functioning at 9 months
|
80 units on a scale
Interval 80.0 to 80.0
|
100 units on a scale
Interval 80.0 to 100.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Social Functioning at 9 months
|
80 units on a scale
Interval 80.0 to 80.0
|
100 units on a scale
Interval 90.0 to 100.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL School Functioning at 9 months
|
80 units on a scale
Interval 80.0 to 80.0
|
50 units on a scale
Interval 45.0 to 75.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Physical Functioning at 12 months
|
84.4 units on a scale
Interval 84.4 to 84.4
|
100 units on a scale
Interval 100.0 to 100.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Emotional Functioning at 12 months
|
80 units on a scale
Interval 80.0 to 80.0
|
100 units on a scale
Interval 100.0 to 100.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL Social Functioning at 12 months
|
85 units on a scale
Interval 85.0 to 85.0
|
100 units on a scale
Interval 100.0 to 100.0
|
|
Pediatric Quality of Life Assessment (PedsQL)
PedsQL School Functioning at 12 months
|
75 units on a scale
Interval 75.0 to 75.0
|
100 units on a scale
Interval 100.0 to 100.0
|
Adverse Events
Occipital Nerve Block_Initial Treatment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cervical Medial Branch Block_Initial Treatment
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Crossover to CMBB From Initial ONB
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Crossover to ONB From Initial CMBB
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Occipital Nerve Block_Initial Treatment
n=8 participants at risk
This arm/group represents the total number of patients who were randomized to the occipital nerve block treatment at the start of the study.
|
Cervical Medial Branch Block_Initial Treatment
n=8 participants at risk
This arm/group represents the total number of patients who were randomized to the cervical medial branch block treatment at the start of the study.
|
Crossover to CMBB From Initial ONB
n=3 participants at risk
This arm/group represents the total number of patients who were initially randomized to the occipital nerve block treatment at the start of the study but then crossed over to the cervical medial branch block treatment arm.
|
Crossover to ONB From Initial CMBB
n=2 participants at risk
This arm/group represents the total number of patients who were initially randomized to the cervical medial branch block treatment at the start of the study but then crossed over to the occipital nerve block treatment arm.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Pain at the site of injection
|
62.5%
5/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
75.0%
6/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
66.7%
2/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
2/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Bleeding from the site of injection
|
12.5%
1/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Infection (warmth, redness, swelling) at the site of injection
|
0.00%
0/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Neck stiffness
|
87.5%
7/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
8/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
3/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
2/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Muscle soreness/pain
|
87.5%
7/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
8/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
3/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
2/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Dizziness
|
62.5%
5/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
75.0%
6/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
33.3%
1/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
2/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Upper limb numbness/weakness
|
37.5%
3/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
37.5%
3/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
33.3%
1/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
50.0%
1/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Fatigue
|
87.5%
7/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
87.5%
7/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
66.7%
2/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
2/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Gait instability or balance problems
|
25.0%
2/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
62.5%
5/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
33.3%
1/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
100.0%
2/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Difficulty swallowing
|
0.00%
0/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
37.5%
3/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
|
Surgical and medical procedures
Other
|
37.5%
3/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
25.0%
2/8 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
33.3%
1/3 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
0.00%
0/2 • Self-reported side effect data collected through surveys administered over a 12-month time period evaluated after study termination.
Self-reported side effect data collected through surveys administered over a 12-month time period and Counts reflect the number of patients reporting side effect at least once. Data must be interpreted with caution due to longitudinal data collection design which may reflect results that are unrelated to the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place