Trial · NCT03007420
A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
NCT03007420, Phase 3, Terminated, Boston Children's Hospital; results first posted 2025-10-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Prospective Controlled Treatment Trial for Post-Traumatic Headaches. Trials, record NCT03007420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03007420
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
- NCT number
- NCT03007420
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 16 participants, actual
- Lead sponsor
- Boston Children's Hospital
- Conditions
- Post-Traumatic Headaches
- Interventions
- Occipital Nerve Block (ONB) using lidocaine and dexamethosone, Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone
- First posted
- 2017-01-02
- Last updated
- 2025-10-14
- Results first posted
- 2025-10-14
- Limitations and caveats
Even though post-traumatic headache management is multimodal, we have limited evidence of any current treatment options showing longer term benefits. The trial was preliminary halted due to difficulties with patient recruitment. As such, limited results have been presented which should be interpreted with caution.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pain Score | One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure | 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'. |
| Secondary | Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS) | Baseline, 3 months, 6 months, 9 months, 12 months | 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. |
| Secondary | Pediatric Migraine Disability Assessment (PedMIDAS) | Baseline, 3 months, 6 months, 9 months, 12 months | 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. |
| Secondary | Headache Severity Assessed by Migraine Disability Assessment (MIDAS) | Baseline, 3 months, 6 months, 9 months, 12 months | 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) |
| Secondary | Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS) | Baseline, 3 months, 6 months, 9 months, 12 months | Self-administered questionnaire to quantify headache-related disability |
| Secondary | Functional Disability Inventory Scores (FDI) | Baseline, 3 months, 6 months, 9 months, 12 months | 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. |
| Secondary | Pain Disability Index (PDI) | Baseline, 3 months, 6 months, 9 months, 12 months | 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. |
| Secondary | World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF) | Baseline, 2 months, 3 months, 6 months, 9 months, 12 months | 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. |
| Secondary | Pediatric Quality of Life Assessment (PedsQL) | Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pain Score | One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure | 16 patients provided baseline pain score data that has been presented in the Baseline Demographics section. Post-procedure pain scores have been reported below. | units on a scale | MEDIAN |
| SECONDARY | Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS) | Baseline, 3 months, 6 months, 9 months, 12 months | The Migraine Disability Assessment (MIDAS) is validated for patients 18 years and older only. | units on a scale | MEDIAN |
| SECONDARY | Pediatric Migraine Disability Assessment (PedMIDAS) | Baseline, 3 months, 6 months, 9 months, 12 months | PedsMIDAS is only validated for patients for patients under the age of 18 years. | units on a scale | MEDIAN |
| SECONDARY | Headache Severity Assessed by Migraine Disability Assessment (MIDAS) | Baseline, 3 months, 6 months, 9 months, 12 months | The Migraine Disability Assessment (MIDAS) is validated for patients 18 years and older only. | units on a scale | MEDIAN |
| SECONDARY | Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS) | Baseline, 3 months, 6 months, 9 months, 12 months | 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. | ||
| SECONDARY | Functional Disability Inventory Scores (FDI) | Baseline, 3 months, 6 months, 9 months, 12 months | The FDI is validated in patients under the age 18 years. | units on a scale | MEDIAN |
| SECONDARY | Pain Disability Index (PDI) | Baseline, 3 months, 6 months, 9 months, 12 months | The PDI is validated in patients 18 years of age or older. | units on a scale | MEDIAN |
| SECONDARY | World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF) | Baseline, 2 months, 3 months, 6 months, 9 months, 12 months | WHOQOL-BREF is validated in adults 18 years of age or older. | units on a scale | MEDIAN |
| SECONDARY | Pediatric Quality of Life Assessment (PedsQL) | Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure | The PEDsQL assessment is validated in patients under the age 18 years. | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group153
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pain Score | Occipital Nerve Block | Numerical Rating Scale at 1 week post procedure timepoint | 2.9 | Inter-Quartile Range 1.5 to 4.7 | units on a scale |
| Pain Score | Cervical Medial Branch Block | Numerical Rating Scale at 1 week post procedure timepoint | 3.7 | Inter-Quartile Range 1.5 to 4.5 | units on a scale |
| Pain Score | Occipital Nerve Block | Numerical Rating Scale at 1 month post procedure time point | 1 | Inter-Quartile Range 0.4 to 2.4 | units on a scale |
| Pain Score | Cervical Medial Branch Block | Numerical Rating Scale at 1 month post procedure time point | 1.6 | Inter-Quartile Range 1 to 3.3 | units on a scale |
| Pain Score | Occipital Nerve Block | Numerical Rating Scale at 2 months post procedure time point | 2.3 | Inter-Quartile Range 1.3 to 4.6 | units on a scale |
| Pain Score | Cervical Medial Branch Block | Numerical Rating Scale at 2 months post procedure time point | 5.2 | Inter-Quartile Range 2 to 5.5 | units on a scale |
| Pain Score | Occipital Nerve Block | Numerical Rating Scale at 3 months post procedure time | 2.1 | Inter-Quartile Range 1.2 to 3 | units on a scale |
| Pain Score | Cervical Medial Branch Block | Numerical Rating Scale at 3 months post procedure time | 1.7 | Inter-Quartile Range 0 to 3.5 | units on a scale |
| Pain Score | Occipital Nerve Block | Numerical Rating Scale at 6 months post procedure time | 1.8 | Inter-Quartile Range 1 to 4 | units on a scale |
| Pain Score | Cervical Medial Branch Block | Numerical Rating Scale at 6 months post procedure time | 0.8 | Inter-Quartile Range 0.4 to 2.9 | units on a scale |
1 to 10 of 153Source ClinicalTrials.gov
See all 153 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Occipital Nerve Block | 8 | |
| Overall Study | STARTED | Cervical Medial Branch Block | 8 | |
| Overall Study | Crossover | Occipital Nerve Block | 3 | |
| Overall Study | Crossover | Cervical Medial Branch Block | 2 | |
| Overall Study | COMPLETED | Occipital Nerve Block | 8 | |
| Overall Study | COMPLETED | Cervical Medial Branch Block | 5 | |
| Overall Study | NOT COMPLETED | Occipital Nerve Block | 0 | |
| Overall Study | NOT COMPLETED | Cervical Medial Branch Block | 3 |
Source ClinicalTrials.gov
Adverse events44
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain at the site of injection | Surgical and medical procedures | Occipital Nerve Block_Initial Treatment | 5 | 8 | |
| other | Pain at the site of injection | Surgical and medical procedures | Cervical Medial Branch Block_Initial Treatment | 6 | 8 | |
| other | Pain at the site of injection | Surgical and medical procedures | Crossover to CMBB From Initial ONB | 2 | 3 | |
| other | Pain at the site of injection | Surgical and medical procedures | Crossover to ONB From Initial CMBB | 2 | 2 | |
| other | Bleeding from the site of injection | Surgical and medical procedures | Occipital Nerve Block_Initial Treatment | 1 | 8 | |
| other | Bleeding from the site of injection | Surgical and medical procedures | Cervical Medial Branch Block_Initial Treatment | 0 | 8 | |
| other | Bleeding from the site of injection | Surgical and medical procedures | Crossover to CMBB From Initial ONB | 0 | 3 | |
| other | Bleeding from the site of injection | Surgical and medical procedures | Crossover to ONB From Initial CMBB | 0 | 2 | |
| other | Infection (warmth, redness, swelling) at the site of injection | Surgical and medical procedures | Occipital Nerve Block_Initial Treatment | 0 | 8 | |
| other | Infection (warmth, redness, swelling) at the site of injection | Surgical and medical procedures | Cervical Medial Branch Block_Initial Treatment | 0 | 8 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Occipital Nerve Block_Initial Treatment | 0 | 8 |
| Total, all-cause mortality | Cervical Medial Branch Block_Initial Treatment | 0 | 8 |
| Total, all-cause mortality | Crossover to CMBB From Initial ONB | 0 | 3 |
| Total, all-cause mortality | Crossover to ONB From Initial CMBB | 0 | 2 |
| Total, other adverse events | Occipital Nerve Block_Initial Treatment | 8 | 8 |
| Total, other adverse events | Cervical Medial Branch Block_Initial Treatment | 8 | 8 |
| Total, other adverse events | Crossover to CMBB From Initial ONB | 3 | 3 |
| Total, other adverse events | Crossover to ONB From Initial CMBB | 2 | 2 |
| Total, serious adverse events | Occipital Nerve Block_Initial Treatment | 0 | 8 |
| Total, serious adverse events | Cervical Medial Branch Block_Initial Treatment | 0 | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT03007420/results?page=2