Trial · NCT04676399
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Blood Pressure Measurement From Visit 1 to Visit 2 | 1 week | Measurements of blood pressure via arm cuff and finger cuff |
| Primary | Change in Blood Pressure Measurement From Visit 2 to Visit 3 | 1 week | Measurements of blood pressure via arm cuff and finger cuff |
| Primary | Change in Blood Pressure Measurement From Visit 3 to Visit 4 | 1 week | Measurements of blood pressure via arm cuff and finger cuff |
| Primary | Change in Blood Pressure Measurement From Visit 4 to Visit 5 | 2 week | Measurements of blood pressure via arm cuff and finger cuff |
| Primary | Change from Visit 1 PainDETECT Questionnaire to Visit 2 | 1 week | A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare. Neuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain. |
| Primary | Change from Visit 2 PainDETECT Questionnaire to Visit 3 | 1 week | A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare. Neuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain. |
| Primary | Change from Visit 3 PainDETECT Questionnaire to Visit 4 | 1 week | A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare. Neuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain. |
| Primary | Change from Visit 4 PainDETECT Questionnaire to Visit 5 | 2 week | A battery of questionnaires is intended to understand key aspects of pain, mood, and function as quickly and efficiently as possible. The focus of these measures is on obtaining an accurate assessment of pain, while also asking about physical function, anxiety, and other associated somatic disturbances. These questionnaires will be taken prior to SCS implant (Baseline) and after SCS implant (1 week post-op, 4 weeks post-op, and 8 weeks post-op ) to assess and compare. Neuropathic Pain Descriptors: The Pain DETECT is a 9-item measure of sensory descriptors and spatial and temporal characteristics that has demonstrated utility in identifying central neuropathic pain. |
| Primary | Visit 1 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work | Visit 1 (Day 1) | Catecholamines( Norepinephrine) Blood Test: pg/mL • normal range for norepinephrine is 70 to 1700 pg/mL Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL * IL-6 normal values was 6-31 pg/mL * TNF-α 5 pg/mL, |
| Primary | Visit 1 Lipid Panel Blood Work Results | Visit 1 (Day 1) | Lipid panel Blood Test: mg/dL, * Total Cholesterol Less than 170mg/dL * Non-HDL Less than 120mg/dL * LDL Less than 100mg/dL * HDL More than 45mg/dL |
| Primary | Visit 1 Comprehensive Metabolic Panel Blood Work Results | Visit 1 (Day 1) | Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L * Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L) * Alkaline phosphatase: 20 to 130 U/L * ALT (alanine aminotransferase): 4 to 36 U/L * AST (aspartate aminotransferase): 8 to 33 U/L * BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L) * Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L) * Chloride: 96 to 106 mEq/L (96 to 106 mmol/L) * CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L) * Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L) * Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L) * Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L) * Sodium: 135 to 145 mEq/L (135 to 145 mmol/L) * Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L) * Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L) |
| Primary | Visit 1 Stored Plasma Blood Work Results | Visit 1 (Day 1) | Stored plasma for inflammatory markers |
| Primary | Visit 2 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results | Visit 2 (Day 7) | Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L * Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L) * Alkaline phosphatase: 20 to 130 U/L * ALT (alanine aminotransferase): 4 to 36 U/L * AST (aspartate aminotransferase): 8 to 33 U/L * BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L) * Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L) * Chloride: 96 to 106 mEq/L (96 to 106 mmol/L) * CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L) * Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L) * Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L) * Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L) * Sodium: 135 to 145 mEq/L (135 to 145 mmol/L) * Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L) * Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L) |
| Primary | Visit 3 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results | Visit 3 (Day 14) | Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L * Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L) * Alkaline phosphatase: 20 to 130 U/L * ALT (alanine aminotransferase): 4 to 36 U/L * AST (aspartate aminotransferase): 8 to 33 U/L * BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L) * Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L) * Chloride: 96 to 106 mEq/L (96 to 106 mmol/L) * CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L) * Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L) * Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L) * Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L) * Sodium: 135 to 145 mEq/L (135 to 145 mmol/L) * Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L) * Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L) |
| Primary | Visit 4 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results | Visit 4 (Day 21) | Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L * Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L) * Alkaline phosphatase: 20 to 130 U/L * ALT (alanine aminotransferase): 4 to 36 U/L * AST (aspartate aminotransferase): 8 to 33 U/L * BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L) * Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L) * Chloride: 96 to 106 mEq/L (96 to 106 mmol/L) * CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L) * Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L) * Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L) * Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L) * Sodium: 135 to 145 mEq/L (135 to 145 mmol/L) * Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L) * Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L) |
| Primary | Visit 5 Comprehensive Metabolic Panel/Electrolyte Check Blood Work Results | Visit 5 (Day 28) | Metabolic Panel Blood Test (Electrolyte Check): mg/dL, mmol/L , g/dL, U/L, mEq/L * Albumin: 3.4 to 5.4 g/dL (34 to 54 g/L) * Alkaline phosphatase: 20 to 130 U/L * ALT (alanine aminotransferase): 4 to 36 U/L * AST (aspartate aminotransferase): 8 to 33 U/L * BUN (blood urea nitrogen): 6 to 20 mg/dL (2.14 to 7.14 mmol/L) * Calcium: 8.5 to 10.2 mg/dL (2.13 to 2.55 mmol/L) * Chloride: 96 to 106 mEq/L (96 to 106 mmol/L) * CO2 (carbon dioxide): 23 to 29 mEq/L (23 to 29 mmol/L) * Creatinine: 0.6 to 1.3 mg/dL (53 to 114.9 µmol/L) * Glucose: 70 to 100 mg/dL (3.9 to 5.6 mmol/L) * Potassium: 3.7 to 5.2 mEq/L (3.70 to 5.20 mmol/L) * Sodium: 135 to 145 mEq/L (135 to 145 mmol/L) * Total bilirubin: 0.1 to 1.2 mg/dL (2 to 21 µmol/L) * Total protein: 6.0 to 8.3 g/dL (60 to 83 g/L) |
| Primary | Visit 5 Lipid Panel Blood Work Results | Visit 5 (Day 28) | Lipid panel Blood Test: mg/dL, * Total Cholesterol Less than 170mg/dL * Non-HDL Less than 120mg/dL * LDL Less than 100mg/dL * HDL More than 45mg/dL |
| Primary | Visit 5 Stored Plasma Blood Work Results | Visit 5 (Day 35) | Stored plasma for inflammatory markers Blood Test |
| Primary | Visit 5 Catecholamines( Norepinephrine) & Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Work | Visit 5 (Day 28) | Catecholamines( Norepinephrine) Blood Test: pg/mL • normal range for norepinephrine is 70 to 1700 pg/mL Tumor necrosis factor-alpha (TNF-α) and interlukin-6 (IL6) Blood Test: pg/mL * IL-6 normal values was 6-31 pg/mL * TNF-α 5 pg/mL, |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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