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Study terminated prematurely by the study Principal Investigator due to slow patient recruitment.
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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| Harvard University | OTHER |
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Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for PTH management except for conservative modalities, such as cognitive rest, physical therapy, and neuropathic pain medications, all of which have minimal evidence to support them.
The investigators propose a randomized, controlled, clinical trial and prospective follow-up study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and cervical medial branch block (CMBB) in the management of PTH.
Adolescents and adults (14-45 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.
Headaches and neck pain following a concussion are potentially treatable and resolve over time. Nerve blockade may enhance the recovery of appropriate neural circuits involved in the pathophysiology of a chronic headache. Currently, no evidence-based guidelines exist for treatment of PTH. Adoption of "brain rest" for 1-2 weeks, followed by gradual return to activity and avoiding "second-impact syndrome" are current practice. The use of medications controlling neuropathic pain is of partial benefit for some. Adverse effects like sedation, mood changes, cardiac side effects of pharmacologic agents are often not compatible with the demands of athletics. For those patients where sports performance is paramount, they may therefore not be able to tolerate regular medications. The incidence of chronic post-concussive headaches (> 3 months) at one year is 8.4% - 35% and at four years is up to 25%. Therefore, patients can have a significant disability from their post-traumatic headaches for many years after their injury. Without appropriate treatment, these headaches can remain as chronic headaches. Over-the-counter and other symptomatic medication overuse can exacerbate and prolong PTH significantly, secondary to rebound headaches. Successful treatment is essential since PTH limits return to sports as well as more general activities of living, such as work and school. Most interventions currently in use partially help and take several weeks to months for a noticeable benefit. PTH interventions, including ONB and CMBB, are employed in the treatment of primary headache disorders and neck pain from cervical arthritis and may provide more improved, faster and more sustained pain relief in many patients. Also, given that most of the action of the nerve blocks is local, there are significantly fewer side effects than in more standard headache medications. Injections that use corticosteroids may be beneficial in a post-traumatic headache by reducing inflammation and therefore mechanical allodynia. Injection of corticosteroids in the cervical facet joint area has shown up to 13 months of pain relief. This prolonged effect may be secondary to central pain modulation. Ultimately, nerve blocks may be a more effective and efficient post-traumatic headache given the onset of effect and the minimal side effects.
To date, there have been no prospective studies of procedural treatments for medically refractory PTH and none in the adolescent and young adult population in whom football injuries are common. Despite the frequent clinical practice of using ONB and CMBB for occipital neuralgia, cervical arthritis, and cervicogenic headaches, there has been no adequate scientific investigation into the use of these interventions for PTH. Given that PTH is typically felt to be secondary to an inflammatory reaction to trauma, the use of injection of corticosteroids may be more effective in PTH than in common headache disorders.
The investigators propose a randomized, prospective, controlled treatment trial to evaluate the efficacy of minimally invasive nerve block interventions (ONB and CMBB) as treatments for PTH and neck pain in adolescents and adults aged 14-45 years of age with PTH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occipital Nerve Block | Experimental | 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. |
|
| Cervical Medial Branch Block | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occipital Nerve Block (ONB) using lidocaine and dexamethosone | Drug | Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score | 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'. | One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS) | 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. | Baseline, 3 months, 6 months, 9 months, 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Beth Israel Deaconess Medical Center |
The investigators do not plan to share any IPD collected during the study with other researchers not included in the protocol.
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Patients were recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center. Eligibility Criteria included:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This study was terminated early due to slow patient recruitment. Given this, data has been analyzed for all patients enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score | 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'. | 16 patients provided baseline pain score data that has been presented in the Baseline Demographics section. Post-procedure pain scores have been reported below. | Posted | Median | Inter-Quartile Range | units on a scale | One week, 1 month, 2 months, 3 months, 6months, 9 months, 12 months post-procedure |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Occipital Nerve Block_Initial Treatment | This arm/group represents the total number of patients who were randomized to the occipital nerve block treatment at the start of the study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at the site of injection | Surgical and medical procedures | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pradeep Dinakar, MD | Boston Children's Hospital | 857-218-3556 | Pradeep.Dinakar@childrens.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2022 | Jun 16, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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|
| Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone | Drug | Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side. |
|
| Pediatric Migraine Disability Assessment (PedMIDAS) | 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. | Baseline, 3 months, 6 months, 9 months, 12 months |
| Headache Severity Assessed by Migraine Disability Assessment (MIDAS) | 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) | Baseline, 3 months, 6 months, 9 months, 12 months |
| Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS) | Self-administered questionnaire to quantify headache-related disability | Baseline, 3 months, 6 months, 9 months, 12 months |
| Functional Disability Inventory Scores (FDI) | 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. | Baseline, 3 months, 6 months, 9 months, 12 months |
| Pain Disability Index (PDI) | 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. | Baseline, 3 months, 6 months, 9 months, 12 months |
| World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF) | 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. | Baseline, 2 months, 3 months, 6 months, 9 months, 12 months |
| Pediatric Quality of Life Assessment (PedsQL) | 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. | Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pain Score at Baseline | Pain Scores were assessed using the Numerical Rating Scale 0-10 with 0 being 'no pain' and 10 being 'worst pain imaginable'. | Median | Inter-Quartile Range | units on a scale |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Cervical Medial Branch Block | 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. |
|
|
| Secondary | Migraine Disability Assessed Using the Migraine Disability Assessment (MIDAS) | 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. | The Migraine Disability Assessment (MIDAS) is validated for patients 18 years and older only. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 3 months, 6 months, 9 months, 12 months |
|
|
|
| Secondary | Pediatric Migraine Disability Assessment (PedMIDAS) | 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. | PedsMIDAS is only validated for patients for patients under the age of 18 years. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 3 months, 6 months, 9 months, 12 months |
|
|
|
| Secondary | Headache Severity Assessed by Migraine Disability Assessment (MIDAS) | 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) | The Migraine Disability Assessment (MIDAS) is validated for patients 18 years and older only. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 3 months, 6 months, 9 months, 12 months |
|
|
|
| Secondary | Headache Severity Assessed by the Pediatric Migraine Disability Assessment (PedMIDAS) | Self-administered questionnaire to quantify headache-related disability | 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. | Posted | Baseline, 3 months, 6 months, 9 months, 12 months |
|
|
| Secondary | Functional Disability Inventory Scores (FDI) | 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. | The FDI is validated in patients under the age 18 years. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 3 months, 6 months, 9 months, 12 months |
|
|
|
| Secondary | Pain Disability Index (PDI) | 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. | The PDI is validated in patients 18 years of age or older. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 3 months, 6 months, 9 months, 12 months |
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| Secondary | World Health Organization Quality of Life - Brief Assessment (WHOQOL-BREF) | 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. | WHOQOL-BREF is validated in adults 18 years of age or older. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months, 3 months, 6 months, 9 months, 12 months |
|
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| Secondary | Pediatric Quality of Life Assessment (PedsQL) | 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. | The PEDsQL assessment is validated in patients under the age 18 years. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 2 months, 3 months, 6 months, 9 months, 12 months post procedure |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | Cervical Medial Branch Block_Initial Treatment | 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. | 0 | 8 | 0 | 8 | 8 | 8 |
| EG002 | Crossover to CMBB From Initial ONB | 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. | 0 | 3 | 0 | 3 | 3 | 3 |
| EG003 | Crossover to ONB From Initial CMBB | 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. | 0 | 2 | 0 | 2 | 2 | 2 |
| Bleeding from the site of injection | Surgical and medical procedures | Systematic Assessment |
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| Infection (warmth, redness, swelling) at the site of injection | Surgical and medical procedures | Systematic Assessment |
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| Neck stiffness | Surgical and medical procedures | Systematic Assessment |
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| Muscle soreness/pain | Surgical and medical procedures | Systematic Assessment |
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| Dizziness | Surgical and medical procedures | Systematic Assessment |
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| Upper limb numbness/weakness | Surgical and medical procedures | Systematic Assessment |
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| Fatigue | Surgical and medical procedures | Systematic Assessment |
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| Gait instability or balance problems | Surgical and medical procedures | Systematic Assessment |
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| Difficulty swallowing | Surgical and medical procedures | Systematic Assessment |
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| Other | Surgical and medical procedures | Systematic Assessment |
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| D009422 | Nervous System Diseases |
| MIDAS Score at 3 months |
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| MIDAS Score at 6 months |
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| MIDAS Score at 9 months |
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| MIDAS Score at 12 months |
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| PedsMIDAS at 3 months |
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| PedsMIDAS at 6 months |
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| PedsMIDAS at 9 months |
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| PedsMIDAS at 12 months |
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| MIDAS severity at 3 months |
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| MIDAS severity at 6 months |
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| MIDAS severity at 9 months |
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| MIDAS severity at 12 months |
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| FDI Score at 3 months |
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| FDI Score at 6 months |
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| FDI Score at 9 months |
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| FDI Score at 12 months |
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| PDI Score at 3 months |
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| PDI Score at 6 months |
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| PDI Score at 9 months |
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| PDI Score at 12 months |
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| HOQOL-BREF Psychological Health Scores at Baseline |
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| HOQOL-BREF Social Relationship Scores at Baseline |
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| HOQOL-BREF Environment Scores at Baseline |
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| HOQOL-BREF Physical Health Scores at 2 months |
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| HOQOL-BREF Psychological Health Scores at 2 months |
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| HOQOL-BREF Social Relationships Scores at 2 months |
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| HOQOL-BREF Environment Scores at 2 months |
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| HOQOL-BREF Physical Health Scores at 3 months |
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| HOQOL-BREF Psychological Health Scores at 3 months |
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| WHOQOL-BREF Social Relationship Scores at 3 months |
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| WHOQOL-BREF Environment Scores at 3 months |
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| WHOQOL-BREF Physical Health Scores at 6 months |
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| WHOQOL-BREF Psychological Health Scores at 6 months |
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| WHOQOL-BREF Social Relationship Scores at 6 months |
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| WHOQOL-BREF Environment Scores at 6 months |
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| WHOQOL-BREF Physical Health Scores at 9 months |
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| WHOQOL-BREF Psychological Health Scores at 9 months |
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| WHOQOL-BREF Social Relationship Scores at 9 months |
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| WHOQOL-BREF Environment Scores at 9 months |
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| WHOQOL-BREF Physical Health Scores at 12 months |
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| WHOQOL-BREF Psychological Health Scores at 12 months |
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| WHOQOL-BREF Social Relationship Scores at 12 months |
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| WHOQOL-BREF Environment Scores at 12 months |
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| PedsQL Emotional Functioning at Baseline |
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| PedsQL Social Functioning at Baseline |
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| PedsQL School Functioning at Baseline |
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| PedsQL Physical Functioning at 2 months |
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| PedsQL Emotional Functioning at 2 months |
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| PedsQL Social Functioning at 2 months |
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| PedsQL School Functioning at 2 months |
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| PedsQL Physical Functioning at 3 months |
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| PedsQL Emotional Functioning at 3 months |
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| PedsQL Social Functioning at 3 months |
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| PedsQL School Functioning at 3 months |
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| PedsQL Physical Functioning at 6 months |
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| PedsQL Emotional Functioning at 6 months |
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| PedsQL Social Functioning at 6 months |
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| PedsQL Sleep Functioning at 6 months |
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| PedsQL Physical Functioning at 9 months |
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| PedsQL Emotional Functioning at 9 months |
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| PedsQL Social Functioning at 9 months |
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| PedsQL School Functioning at 9 months |
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| PedsQL Physical Functioning at 12 months |
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| PedsQL Emotional Functioning at 12 months |
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| PedsQL Social Functioning at 12 months |
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| PedsQL School Functioning at 12 months |
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