| Primary | Neuropathic Pain Scale - Pain Intensity | The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. Item numbers ask respondents to describe the intensity of their combat limb pain on a scale of 0 - 10, where "0" is no pain and "10" is the most intense pain imaginable. | | Posted | | Mean | Standard Error | units on the Neuropathic Pain Scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. | | OG003 | No RA | During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia. |
| | Units | Counts |
|---|
| Participants | - OG000126
- OG00142
- OG00220
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003± 0.16
- OG0013.44± 0.3
- OG0023.92± 0.45
- OG003
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. | Mixed Models Analysis | | <0.0001 | | Slope | -0.03230 | Standard Error of the Mean | 0.006190 | 2-Sided | 95 | -0.0448 | -0.02013 | | | | | Superiority or Other |
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| Primary | Neuropathic Pain Scale - Overall Pain Quality | The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. The NPS Overall Pain Quality composite score is a measure of six distinct pain qualities of respondents' combat limb pain on a scale of 0 - 10, where "0" is no pain and "10" is the most intense sensation imaginable. The six pain qualities included in the composite score is sharp, hot, dull, cold, itchy, and sensitive to touch. | | Posted | | Mean | Standard Error | units on the Neuropathic Pain Scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury |
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| Primary | Neuropathic Pain Scale - Total Score | The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. It has a scale of 0 - 10, where "0" is no pain and "10" is the most intense sensation imaginable. The NPS total score is an average of all ten items. | | Posted | | Mean | Standard Error | units on the Neuropathic Pain Scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. |
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| Primary | Brief Pain Inventory - Worst Pain | The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Worst Pain asks the respondent to rate worst pain in the past week from the combat limb injury on a scale of 0 to 10, where "0" is no pain, and "10" is pain as bad as you can imagine. | | Posted | | Mean | Standard Error | units on the Brief Pain Inventory Scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. |
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| Primary | Brief Pain Inventory - Average Pain | The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Average Pain asks the respondent to rate combat limb injury pain on average (no time frame given) on a scale of 0 to 10, where "0" is no pain, and "10" is pain as bad as you can imagine. | | Posted | | Mean | Standard Error | units on the Brief Pain Inventory Scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. |
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| Primary | Brief Pain Inventory - Pain Interference | The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is scored as the mean of the seven interference items, each ranging 0 to 10, where "0" is pain from combat limb injury does not interfere and "10" is pain from combat limb injury completely interferes with this aspect of daily life. | | Posted | | Mean | Standard Error | units on the Brief Pain Inventory Scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | |
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| Primary | Brief Pain Inventory - Treatment Relief | The Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess the severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures in the last 24 hours, how much relief pain treatments or medications provided on a scale of 0%, meaning no relief, to 100%, indicating complete relief. | | Posted | | Mean | Standard Error | percentage of pain relief | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. |
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| Primary | SF-36 Physical Component Summary | The Physical component score (PCS) is an aggregate of the eight subscale scores measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is calculated for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the PCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the PCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996 | | Posted | | Mean | Standard Error | t-score | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. |
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| Primary | SF-36 Mental Component Summary | The Mental component score (MCS) is an aggregate of the eight subscale scores that account for measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the MCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the MCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996 | | Posted | | Mean | Standard Error | t-score | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. |
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| Primary | Post Traumatic Stress Disorder (PTSD) Total Severity | Post-Traumatic Stress Disorder Checklist (PCL): The PCL is a 17-item PTSD assessment instrument that asks respondents to rate the extent to which they have experienced each of the 17 diagnostic symptoms for PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). Scores are computed by adding the 17 items scored 1 to 5. Scores range from 17 to 85. Higher scores indicate higher severity of symptoms. | | Posted | | Mean | Standard Error | units on the PCL scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. |
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| Primary | Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. | | Posted | | Mean | Standard Error | units on TOPS scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | |
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| Primary | Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the health care satisfaction scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied. | | Posted | | Mean | Standard Error | units on TOPS scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | |
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| Primary | Treatment Outcomes in Pain Survey (TOPS):Life Control | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. | | Posted | | Mean | Standard Error | units on TOPS scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | |
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| Primary | Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. | | Posted | | Mean | Standard Error | units on TOPS scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury |
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| Primary | Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the satisfaction with outcomes scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied. | | Posted | | Mean | Standard Error | units on TOPS scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | |
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| Primary | Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. | | Posted | | Mean | Standard Error | units on TOPS scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | |
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| Primary | Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses | Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain. | | Posted | | Mean | Standard Error | units on TOPS scale | | Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months | | | | ID | Title | Description |
|---|
| OG000 | RA Within 7 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. | | OG001 | RA 8 - 14 Days From Injury | During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. | | OG002 | RA > 14 Days From Injury | |
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