Understanding the association between perceived injustice, depression symptoms, and stigma in individuals with traumatic spinal cord injury.

STUDY DESIGN: This is a secondary analysis of data from a cross-sectional, observational study. OBJECTIVES: The study aimed to determine whether stigma mediates the relationship between preceived injustice and depression symptoms among individuals with spinal cord injuries. SETTING: Secondary analysis of participants enrolled in the Spinal Cord Injury Model System at a specialty rehabilitation hospital in the Western United States. METHODS: A sample of 225 participants completed the questionnaires; eight participants were removed due to incomplete data, resulting in a final sample size of 217 participants (79% male; 21% female). Participants were, on average, 53 years old and were predominantly male, white, and 20 years post-injury. A bootstrapping mediation analysis was conducted to evaluate the stigma-mediated relationship between injustice appraisals and depression symptoms. Injustice appraisals were assessed using the Injustice Experience Questionnaire, stigma with the Spinal Cord Injury Quality of Life Stigma-Short Form, and depression symptoms with the Patient Health Questionnaire-9. RESULTS: Stigma was found to mediate the relationship between injustice appraisals and depression, with an estimated proportion mediated of 80.9% (p ≤ 0.0001). CONCLUSIONS: This study provides a novel finding that the relationship between injustice appraisals and depression symptoms is mediated by stigma. Consistent with previous research, injustice appraisals were associated with greater severity of depression symptoms. Results provide further evidence for the role of injustice appraisals after spinal cord injury and a potential mechanism (i.e., stigma) by which it may exert its effect on depression symptoms.

Changes in essential care in individuals with spinal cord injury during the COVID-19 pandemic.

STUDY DESIGN: Cross-sectional, observational study. OBJECTIVES: To determine whether changes in essential care during the COVID-19 pandemic impacted satisfaction with activities, participation, and relationships among individuals with spinal cord injury (SCI). SETTING: Data were collected online between December 31, 2020 and February 14, 2021 among community dwelling adults with SCI (N = 123). METHODS: The primary outcome variables were satisfaction with the ability to complete activities of daily living (ADLs) (mobility, dressing, feeding, and toileting), as well as satisfaction with participation in household and recreational activities, and satisfaction with relationships among friends, family, and with the status of one's relationship measured with the International Spinal Cord Injury Data Sets Activities and Participation Basic Data Set. Primary predictors were age, gender, time since injury, completeness of injury, injury level, access to mental health, access to medications, access to medical supplies, and access to personal care assistants (PCAs). RESULTS: Impact on access to mental health and impact on access to supplies were the most common factors affecting satisfaction with activities, participation, and relationships for individuals with SCI during the COVID-19 pandemic. Impact on access to PCAs/homecare was also found to impact certain outcomes including feeding and participation in household activities. CONCLUSIONS: Future supply chain disruptions from pandemics or natural disasters could have wide-reaching effects for individuals with SCIs. Thus, further research and advocacy is needed to improve mental health care planning and supply chain access during subsequent natural disasters.

Resilience and mental health in individuals with spinal cord injury during the COVID-19 pandemic.

STUDY DESIGN: Cross-sectional, observational study. OBJECTIVES: To understand how resilience, access to personal care attendants (PCAs) and medical supplies, and concerns about medical rationing, finances, and social isolation are related to overall and mental health in individuals with spinal cord injury (SCI) in the context of the COVID-19 pandemic. SETTING: Community dwelling adults (N = 187) with SCI. METHODS: Data were collected online between May 1, 2020 and August 31, 2020. Outcomes were overall and mental health, depression and anxiety symptoms, and quality of life (QoL). Predictors were resilience, access to PCAs and medical supplies, and concerns about medical rationing, finances, and social isolation. RESULTS: Incomplete injury, concern about medical rationing, medical supply disruption, and social isolation predicted a greater perceived impact of the pandemic on overall heath. Younger age, decreased resilience, and concern about medical rationing and social isolation predicted greater perceived impact of the pandemic on mental health. Decreased resilience and concern about medical rationing and finances predicted increased anxiety symptoms. Incomplete injury, believing that medical rationing was occurring, decreased resilience, and concern about finances and social isolation predicted increased depressive symptoms. Decreased resilience and concern about finances, medical rationing, and social isolation predicted lower QoL. CONCLUSIONS: The negative effects of the pandemic on the overall and mental health of individuals with SCI may be ameliorated by resilience. In future crises, it may be beneficial to screen individuals for resilience so that those with decreased resilience are offered the appropriate resources to enhance resilience and improve overall wellbeing.

Validation of the Injustice Experience Questionnaire (IEQ) in a spinal cord injury population.

STUDY DESIGN: Retrospective analysis of cross-sectional data. OBJECTIVES: To verify the factor structure of the Injustice Experience Questionnaire (IEQ) using a sample of individuals with spinal cord injury (SCI) and to assess IEQ scale reliability and construct validity using the same population. SETTING: Two SCI rehabilitation sites in the United States. METHODS: Three datasets were combined to conduct this validation study. The sample consisted of 341 adults with SCI who completed the IEQ, measures of psychological distress and pain, and provided sociodemographic and injury-related information. A series of confirmatory factor analyses (CFA) and exploratory factor analyses (EFA) were conducted to verify the two-factor structure of the IEQ, Cronbach's alpha was used to demonstrate scale reliability, and correlations between the IEQ and measures of pain and psychological distress were examined to assess construct validity. RESULTS: Poor model fit was observed for the two-factor structure of the IEQ as well as for the subsequent factor-structures that were explored. The IEQ demonstrated strong scale reliability (α = 0.89) and correlations between the IEQ and measures of pain and psychological distress were in the expected direction, indicating good construct validity. CONCLUSIONS: In this preliminary validation study, we failed to confirm the two-factor structure of the IEQ in a population of individuals with SCI. Though good scale reliability and construct validity were observed, further study is needed to refine the IEQ for use in this population.

Volunteering and its association with participation and life satisfaction following traumatic brain injury.

Background: Volunteering has been found to improve life satisfaction and participation in the general population, but its impact has not been thoroughly studied among those with traumatic brain injury (TBI). It is important to investigate whether volunteering is helpful in addressing participation and life satisfaction to inform future treatment.Objective: To characterize those who volunteer after moderate-severe TBI and to investigate the association of volunteering with participation and life satisfaction after TBI.Methods: Using data from a single site contributing to the TBI Model Systems National Database, a retrospective analysis of 725 individuals with TBI was conducted. General Linear Models were used to compare outcomes of those who volunteer and those who do not after controlling for important covariates.Results: Volunteers were more likely to be employed/students, have better current functioning, be further post-injury, non-Hispanic white, and have more education. Significant relationships, after controlling for covariates, were found between volunteering and higher life satisfaction, more frequent community engagement, and greater social relations. No significant relationship between volunteering and productivity emerged.Conclusions: Given the positive relationship between volunteer status with life satisfaction and aspects of participation, future research should investigate the barriers/facilitators of volunteering to improve well-being and participation after TBI.

Improving well-being after traumatic brain injury through volunteering: a randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of a novel intervention facilitating volunteer activity to improve well-being in individuals with traumatic brain injury (TBI). DESIGN: Randomized two-arm controlled trial, with a wait-list control condition (ClinicalTrials.gov NCT#01728350). SETTING: Community-based setting. PARTICIPANTS: Seventy-four community-dwelling individuals at least 1-year post TBI, who had completed inpatient or outpatient TBI rehabilitation. INTERVENTIONS: A novel intervention, HOPE - Helping Others through Purpose and Engagement, involving orientation/training and a 3-month volunteer placement for the participant, along with training for community agencies regarding TBI. MAIN OUTCOME MEASURE(S: ): Satisfaction With Life Scale (SWLS); Flourishing Scale (FS); Brief Symptom Inventory-18 (BSI-18); Scale of Positive and Negative Experience (SPANE); Purpose in Life subscale (one of six in the Ryff Scale of Psychological Well-Being - 54 item version). RESULTS: There were significantly greater improvements in life satisfaction (SWLS) and self-perceived success (FS) in the intervention group compared to the control group. There were no significant treatment effects on the additional secondary measures of well-being, although they trended in a positive direction. CONCLUSIONS: This study supports our primary hypothesis that individuals who take part in a volunteer intervention will demonstrate greater psychological well-being in comparison to a control group.

Results From a Randomized Controlled Trial to Address Balance Deficits After Traumatic Brain Injury.

OBJECTIVE: To evaluate the efficacy of an in-home 12-week physical therapy (PT) intervention that utilized a virtual reality (VR) gaming system to improve balance in individuals with traumatic brain injury (TBI). SETTING: Home-based exercise program (HEP). PARTICIPANTS: Individuals (N=63; traditional HEP n=32; VR n=31) at least 1 year post-TBI, ambulating independently within the home, not currently receiving PT services. MAIN OUTCOME MEASURES: Primary: Community Balance and Mobility Scale (CB&M); Secondary: Balance Evaluation Systems Test (BESTest), Activities-Specific Balance Confidence Scale (ABC), Participation Assessment with Recombined Tools-Objective (PART-O). RESULTS: No significant between-group differences were observed in the CB&M over the study duration (P=.9983) for individuals who received VR compared to those who received a HEP to address balance deficits after chronic TBI nor in any of the secondary outcomes: BESTest (P=.8822); ABC (P=.4343) and PART-O (P=.8822). However, both groups demonstrated significant improvements in CB&M and BESTest from baseline to 6, 12, and at 12 weeks follow-up (all P's <.001). Regardless of treatment group, 52% of participants met or exceeded the minimal detectable change of 8 points on the CB&M at 24 weeks and 38% met or exceeded the minimal detectable change of 7.81 points on the BESTest. CONCLUSION: This study did not find that VR training was more beneficial than a traditional HEP for improving balance. However, individuals with chronic TBI in both treatment groups demonstrated improvements in balance in response to these interventions which were completed independently in the home environment.

Perceived injustice after spinal cord injury: evidence for a distinct psychological construct.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: To identify unique predictors of perceived injustice compared with depression symptoms within the first year after SCI. SETTING: Inpatient rehabilitation program in a large urban region in the Southwestern United States. METHODS: A sample of 74 participants with median time since injury of 52 days completed measures of perceived injustice, depression symptoms, posttraumatic stress symptoms, expected disability, pain intensity, and anger. RESULTS: Three unique predictors of perceived injustice as compared with depression symptoms were found-time since injury, state anger, and sex. These predictors had significantly different relationships with perceived injustice than with depression symptoms. CONCLUSIONS: Results replicate previous findings that perceived injustice is moderately correlated with depression symptoms. However, findings also reveal factors uniquely associated with perceived injustice than with depression symptoms, providing support that these are two separate constructs. Thus, these findings support development of novel interventions targeting perceptions of injustice.

Disrupted sleep predicts next day agitation following moderate to severe brain injury.

Objective: Disrupted sleep is common during acute recovery from traumatic brain injury (TBI) and has been linked to daytime agitation. This study investigated the relationship among nighttime sleep efficiency (SE), total sleep time (TST), wakefulness after sleep onset (WASO), and number of wake bouts (NWB) as measured by actigraphy to observer ratings of agitation for patients with TBI who were undergoing inpatient rehabilitation. Methods: This is a retrospective, observational study of a convenience sample of 65 individuals admitted to TBI inpatient rehabilitation who were monitored with actigraphy and the Agitated Behaviour Scale (ABS) for the first 72 h. Each patient's average SE, TST, WASO, and NWB for the 72-h period was calculated using actigraphy for the rest interval from 2100 to 0700. Daily ABS scores were obtained for each day following the nighttime sleep period. Results: Patients were not significantly different on age, gender, etiology of injury, days post-injury, rehabilitation length of stay, or severity of injury as measured by length of posttraumatic amnesia (PTA). SE and TST were significantly lower for patients with agitation than for patients without agitation. Conclusions: This study suggests a relationship between disrupted sleep and agitation for patients with TBI who are undergoing inpatient rehabilitation.

Physical, Cognitive, and Psychosocial Characteristics Associated With Mortality in Chronic TBI Survivors: A National Institute on Disability, Independent Living, and Rehabilitation Research Traumatic Brain Injury Model Systems Study.

OBJECTIVE: To compare a group of individuals who died more than 1 year posttraumatic brain injury (TBI) with a matched group of survivors and to identify physical function, cognitive function, and/or psychosocial function variables associated with mortality. DESIGN: Secondary analysis of data from a multicenter longitudinal cohort study. SETTING: Acute inpatient rehabilitation facilities and community follow-up. PARTICIPANTS: Individuals 16 years and older with a primary diagnosis of TBI. MAIN OUTCOME MEASURES: Functional Independence Measure (FIM), Disability Rating Scale, Participation Assessment with Recombined Tools Objective, Extended Glasgow Outcome Scale, Satisfaction With Life Scale. RESULTS: Individuals who died were distinguishable from their surviving counterparts. They demonstrated significantly poorer global functioning on all physical, cognitive, and psychosocial functioning variables at their most recent study follow-up visit prior to death. FIM Motor demonstrated the largest difference between survival groups, suggesting that independence in mobility may be particularly indicative of likelihood of longer-term survival. CONCLUSIONS: These findings may inform continued research to elucidate functional characteristics of individuals postchronic TBI prior to their death and to identify opportunities for prevention of accelerated death and interventions to improve health, longevity, and quality of life.

Psychological well-being in individuals living in the community with traumatic brain injury.

BACKGROUND: Well-being and quality of life issues remain a long-term problem for many individuals with traumatic brain injury (TBI). Meaningful activity is key to developing life satisfaction and a sense of contribution to society, yet individuals with TBI are often unable to return to competitive employment. OBJECTIVE: To describe the self-reported psychological well-being of a cohort of unemployed individuals living in the community at least 1 year post TBI with low life satisfaction. METHODS: Seventy-four unemployed individuals with low life satisfaction at least 1 year post TBI were administered measures of psychological well-being and cognitive functioning. RESULTS: This cohort of 74 participants demonstrated cognitive impairment and elevated levels of emotional distress. Significant bivariate relationships were noted among nearly all measures of well-being, and associations were in the directions as expected. Individuals reported low life satisfaction and well-being. Two newer measures of well-being correlated with established measures used with this population. CONCLUSIONS: Individuals with TBI living in the community who are not employed but who seek to be productive reported low life satisfaction and well-being. This study highlights the need for interventions aimed at increasing productivity and meaning in life for individuals with TBI, and a broader understanding of psychological health after TBI.

Test-Retest Reliability of Traumatic Brain Injury Outcome Measures: A Traumatic Brain Injury Model Systems Study.

OBJECTIVE: Evaluate the test-retest reliability of measures that comprise the Traumatic Brain Injury Model Systems follow-up data set. PARTICIPANTS: A total of 224 persons with a moderate-severe traumatic brain injury (TBI) enrolled in the Traumatic Brain Injury Model Systems National Database. DESIGN: Following standard administration of the follow-up interview, a second interview was administered 14 to 28 days later using the same interviewer and the same mode of administration. MAIN MEASURES: Traumatic Brain Injury Model Systems follow-up interview that includes 66 variables comprised (a) single item measures of demographics; employment; general health as well as specific health conditions; rehospitalization; tobacco, alcohol, and other drug use; transportation; and mental health and (b) multi-item instruments: FIM; Participation Assessment With Recombined Tools-Objective; Disability Rating Scale; Glasgow Outcome Scale-Extended; Supervision Rating Scale; Satisfaction With Life Scale; TBI Quality of Life Anxiety and Depression items; and The Ohio State University TBI Identification Method. RESULTS: Intraclass correlation coefficient values ranged from 0.65 to 0.99, weighted kappa values ranged from 0.54 to 0.99, and kappa values ranged from 0.43 to 1.00. Four kappa/weighted kappa estimates fell below 0.60: arrested, psychiatric hospitalization, number of days not in good physical health, and rating of general emotional health. CONCLUSIONS: With few exceptions, good to excellent test-retest reliability estimates were obtained. The findings support the use of these measures in prior and future studies and indicate that persons with moderate-severe TBI can provide reliable self-report.

Impact of religious attendance on psychosocial outcomes for individuals with traumatic brain injury: A NIDILRR funded TBI Model Systems study.

OBJECTIVES: To (1) identify demographic characteristics of individuals with traumatic brain injury (TBI) who attend religious services, (2) understand the relationship between attending religious services and psychosocial outcomes and (3) examine the independent contribution of religious service attendance to psychosocial outcomes while controlling for demographic characteristics, functional status and geographic location at 1, 5 and 10-years post injury. DESIGN: Retrospective, cross-sectional cohort study using secondary data analysis of the TBI Model Systems (TBIMS) National Database (NDB). PARTICIPANTS: TBIMS NDB participants who completed 1, 5 or 10-year follow-up interview with data on religious attendance. A total of 5573 interviews were analysed. OUTCOME MEASURES: Satisfaction with Life scale (SWLS), Generalized Anxiety Disorder (GAD-7), Patient Health Questionnaire (PHQ-9) and Participation Assessment with Recombined Tools-Objective Social sub-scale. RESULTS: Approximately half of the sample was attending religious services at each time point. Attendance was a significant protective factor for each outcome across all three-time periods. After controlling for demographic characteristics, functional status and geographic makeup, religious attendance contributed a small but significant amount of unique variance in all models except for GAD-7 at years 1 and 10. DISCUSSION: This study highlights the benefits of religious attendance on psychosocial outcomes post-TBI. Implications for rehabilitation are discussed.

Exploring the feasibility of heart rate variability biofeedback for individuals with tetraplegia: A pilot clinical trial.

PURPOSE/OBJECTIVE: This study aimed to determine the feasibility of using commercially available heart rate variability (HRV) biofeedback training to improve physiological and self-reported stress and anxiety among adults with tetraplegia. HRV biofeedback teaches individuals to effectively modify their HRV levels in synchronization with their respiration rate and amplitude. RESEARCH METHOD/DESIGN: Thirty participants with tetraplegia were enrolled and allocated into one of two study arms: biofeedback or control. The study was conducted remotely from June 2022 through February 2023. Participants in the biofeedback arm received eight HRV training sessions with physiological monitoring, while participants in the control arm received physiological monitoring only. Outcome measures included feasibility, percentage of time spent in the low-frequency range, the Depression Anxiety Stress Scale-21, the Subjective Units of Distress Scale, and the State-Trait Anxiety Inventory-Y Form. RESULTS: Feasibility was demonstrated with 100% completion of the protocol and no participant withdrawals due to adverse events. The biofeedback arm showed a greater percentage of time spent in the low-frequency range and reported greater improvement in anxiety from baseline to Session 8 on the Subjective Units of Distress Scale compared to the control arm. However, no differences were found between study arms on the Depression Anxiety Stress Scale-21 and State-Trait Anxiety Inventory-Y Form. CONCLUSIONS/IMPLICATIONS: This study demonstrated that a remotely delivered, self-administered HRV biofeedback intervention could feasibly be delivered to individuals with tetraplegia who report moderate-to-high levels of anxiety. Trends in the reduction of physiological and self-reported anxiety were observed. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Exploring perspectives on assistive technology use: barriers, facilitators, and access.

PURPOSE: This qualitative study explored perceived barriers and facilitators to access and utilization of assistive technology (AT) among Veterans and civilians living with tetraplegia. We also explored differences in access to and utilization of AT between civilians and Veterans. MATERIALS AND METHODS: Semi-structured focus groups were conducted with 32 adults (15 Veterans, 17 non-Veterans) living with tetraplegia between the ages of 18 and 65 and who were at least one-year post-injury. Focus groups were conducted at two rehabilitation sites: Craig Hospital and the Louis Stokes Cleveland VA Medical Center. Participants were asked to discuss what they perceive as (1) the facilitators and barriers of AT access and utilization, and (2) the value of AT use in everyday living. Data were analyzed using thematic analysis of verbatim transcripts. RESULTS AND CONCLUSIONS: Facilitators of AT utilization and access included being connected to resources, trial-and-error, and knowledge gained from peers. Barriers to AT use included cost of devices, a general lack of awareness of resources, and requirements for eligibility; the latter two themes were endorsed solely by Veteran participants. Benefits of AT included increased independence, participation, productivity, quality of life, and safety. Findings highlight key facilitators of AT procurement and use, barriers that contribute to underutilization of AT, and important benefits experienced as a result of using AT that underscore the importance of AT for individuals with SCI.

The need to maintain connections with rehabilitation resources (e.g., the Department of Vocational Rehabilitation, occupational and physical therapists, the VA, inpatient facilities) is vital to learning about and procuring AT.There is a need for a tailored approach to address AT underutilization in civilian and Veteran populations.Despite the barriers to AT use and the challenges associated with discovery of AT, utilization of AT may lead to increased independence, participation, productivity, quality of life, and safety.

Feasibility of using remotely delivered Spring Forest Qigong to reduce neuropathic pain in adults with spinal cord injury: a pilot study.

Introduction: Approximately 69% of 299,000 Americans with spinal cord injury (SCI) suffer debilitating chronic neuropathic pain, which is intractable to treatment. The aim of this study is to determine feasibility, as the primary objective, and estimates of efficacy of a remotely delivered Qigong intervention in adults with SCI-related neuropathic pain, as the secondary objective. Methods: We recruited adults with SCI-related neuropathic pain, with SCI ≥3 months, with complete or incomplete SCI, and highest neuropathic pain level of >3 on the Numeric Pain Rating Scale (NPRS), using nationwide volunteer sampling. Using a non-randomized controlled trial design, participants practiced Spring Forest Qigong's "Five Element Qigong Healing Movements" (online video) by combining movement to the best of their ability with kinesthetic imagery, at least 3x/week for 12 weeks. Adherence was automatically tracked through the Spring Forest Qigong website. Outcomes of neuropathic pain intensity (NPRS) were assessed weekly, and SCI-related symptoms were assessed at baseline, 6, and 12 weeks of Qigong practice and at 6-week and 1-year follow-ups. Results: We recruited 23 adults with chronic SCI (7/2021-2/2023). In total, 18 participants started the study and completed all study components, including the 6-week follow-up. Twelve participants completed the 1-year follow-up assessment. Feasibility was demonstrated through participants' willingness to participate, adherence, and acceptability of the study. Mean age of the 18 participants was 60 ± 12 years, and they were 15 ± 11 years post-SCI with the highest baseline neuropathic pain of 7.94 ± 2.33, which was reduced to 4.17 ± 3.07 after 12 weeks of Qigong practice (Cohen's d = 1.75). This pain relief remained at 6-week and 1-year follow-ups. Participants reported reduced spasm frequency (change score 1.17 ± 1.20, d = 0.98) and severity (0.72 ± 1.02, d = 0.71), reduced interference of neuropathic pain on mood (3.44 ± 2.53, d = 1.36), sleep (3.39 ± 2.40, d = 1.41), daily activities (3.17 ± 2.77, d = 1.14), greater ability to perform functional activities (6.68 ± 3.07, d = 2.18), and improved mood (2.33 ± 3.31, d = 0.70) after Qigong. Discussion: Remote Spring Forest Qigong's "Five Element Qigong Healing Movements" practice is feasible in adults with SCI-related neuropathic pain, with promising prolonged results of neuropathic pain relief and improvement in SCI-related symptoms after Qigong practice. Clinical trial registration: https://www.clinicaltrials.gov/ct2/show/NCT04917107, identifier NCT04917107.

Using remotely delivered Spring Forest Qigong™ to reduce neuropathic pain in adults with spinal cord injury: A non-randomized controlled trial.

Importance: The manuscript proposes the feasibility and potential of a remote Qigong intervention to reduce neuropathic pain in adults with spinal cord injury (SCI)-related neuropathic pain. Objective: We determined the feasibility and estimates of efficacy of a remotely delivered Qigong intervention in adults with SCI-related neuropathic pain. Design: This is a non-randomized controlled trial with outcomes assessed at baseline-, 6- and 12-weeks of Qigong practice, and at 6-weeks and 1-year follow-up. Setting: Completely remote clinical trial. Participants: Adults with SCI-related neuropathic pain, with SCI ≥3 months, with complete or incomplete SCI, and highest neuropathic pain level of >3 on the Numeric Pain Rating Scale (NPRS). We used nationwide volunteer sampling.We recruited 23 adults with chronic SCI (7/2021-2/2022). Eighteen participants started the study and completed all study components, including the 6-week follow-up. Twelve participants completed the 1-year follow-up assessment. Intervention: Participants practiced the Spring Forest Qigong™ "Five Element Healing Movements" with an online video by combining movement with kinesthetic imagery, at least 3x/week for 12 weeks. Main Outcomes and Measures: To address the feasibility outcome and track adherence, the website automatically monitored the days and duration that the Qigong video was played. Self-report neuropathic pain intensity and SCI-related symptoms such as spasms, functional performance, mood, and body appreciation were also collected. Results: Eighteen participants, 60±12 years of age, 15±11 years post-SCI had a highest baseline neuropathic pain of 7.94±2.33 on the NPRS, which was reduced to 4.17±3.07 after 12 weeks of Qigong practice (Cohen's d =1.75). This pain relief remained at 6-week and 1-year follow-ups. Participants reported reduced spasm frequency (change score 1.17±1.20, d =0.98) and severity (0.72±1.02, d =0.71), and reduced interference of neuropathic pain on mood (3.44±2.53, d =1.36), sleep (3.39±2.40, d =1.41), and daily activities (3.17±2.77, d =1.14). They had a greater ability to perform functional activities (Patient Specific Functional Scale, 6.68±3.07, d =2.18) and had improved mood (Patient Health Questionnaire-9, 2.33±3.31, d =0.70). Conclusions and Relevance: Our preliminary data demonstrate the feasibility of Qigong practice in adults with SCI-related neuropathic pain and promising results of neuropathic pain relief and improvement in SCI-related symptoms after Qigong practice. Trial Registration this manuscript refers to the quasi-experimental substudy: CREATION: A Clinical Trial of Qigong for Neuropathic Pain Relief in Adults with Spinal Cord Injury, NCT04917107 , https://www.clinicaltrials.gov/ct2/show/NCT04917107 .

Identifying body awareness-related brain network changes after Spring Forest Qigong™ practice or P.Volve low-intensity exercise in adults with chronic low back pain: a feasibility Phase I Randomized Clinical Trial.

Background: Chronic low back pain (cLBP) affects the quality of life of 52 million Americans and leads to an enormous personal and economic burden. A multidisciplinary approach to cLBP management is recommended. Since medication has limited efficacy and there are mounting concerns about opioid addiction, the American College of Physicians and American Pain Society recommend non-pharmacological interventions, such as mind and body approaches (e.g., Qigong, yoga, Tai Chi) before prescribing medications. Of those, Qigong practice might be most accessible given its gentle movements and because it can be performed standing, sitting, or lying down. The three available Qigong studies in adults with cLBP showed that Qigong reduced pain more than waitlist and equally well than exercise. Yet, the duration and/or frequency of Qigong practice were low (<12 weeks or less than 3x/week). The objectives of this study were to investigate the feasibility of practicing Spring Forest Qigong™ or performing P.Volve low intensity exercises 3x/week for 12 weeks, feasibility of recruitment, data collection, delivery of the intervention as intended, as well as identify estimates of efficacy on brain function and behavioral outcomes after Qigong practice or exercise. To our knowledge, this is the first study investigating the feasibility of the potential effect of Qigong on brain function in adults with cLBP. Methods: We conducted a feasibility Phase I Randomized Clinical Trial. Of the 36 adults with cLBP recruited between January 2020 and June 2021, 32 were enrolled and randomized to either 12 weeks of remote Spring Forest Qigong™ practice or remote P.Volve low-intensity exercises. Participants practiced at least 3x/week for 41min/session with online videos. Our main outcome measures were the Numeric Pain Rating Scale (highest, average, and lowest cLBP pain intensity levels in the prior week), assessed weekly and fMRI data (resting-state and task-based fMRI tasks: pain imagery, kinesthetic imagery of a Qigong movement, and robot-guided shape discrimination). We compared baseline resting-state connectivity and brain activation during fMRI tasks in adults with cLBP with data from a healthy control group (n=28) acquired in a prior study. Secondary outcomes included measures of function, disability, body awareness, kinesiophobia, balance, self-efficacy, core muscle strength, and ankle proprioceptive acuity with a custom-build device. Results: Feasibility of the study design and methods was demonstrated with 30 participants completing the study (94% retention) and reporting high satisfaction with the programs; 96% adherence to P.Volve low-intensity exercises, and 128% of the required practice intensity for Spring Forest Qigong™ practice. Both groups saw promising reductions in low back pain (effect sizes Cohen's d =1.01-2.22) and in most other outcomes ( d =0.90-2.33). Markers of ankle proprioception were not significantly elevated in the cLBP group after the interventions. Brain imaging analysis showed weaker parietal operculum and insula network connectivity in adults with cLBP (n=26), compared to data from a healthy control group (n=28). The pain imagery task elicited lower brain activation of insula, parietal operculum, angular gyrus and supramarginal gyrus at baseline in adults with cLBP than in healthy adults. Adults with cLBP had lower precentral gyrus activation than healthy adults for the Qigong movement and robot task at baseline. Pre-post brain function changes showed individual variability: Six (out of 13) participants in the Qigong group showed increased activation in the parietal operculum, angular gyrus, supramarginal gyrus, and precentral gyrus during the Qigong fMRI task. Interpretation: Our data indicate the feasibility and acceptability of using Spring Forest Qigong™ practice or P.Volve low-intensity exercises for cLBP relief showing promising results in terms of pain relief and associated symptoms. Our brain imaging results indicated brain function improvements after 12 weeks of Qigong practice in some participants, pointing to the need for further investigation in larger studies. Trial registration number: ClinicalTrials.gov: NCT04164225 .

Identifying Body Awareness-Related Brain Network Changes after Cognitive Multisensory Rehabilitation for Neuropathic Pain Relief in Adults with Spinal Cord Injury: Delayed Treatment arm Phase I Randomized Controlled Trial.

Background: Neuropathic pain after spinal cord injury (SCI) is notoriously hard to treat. Mechanisms of neuropathic pain are unclear, which makes finding effective treatments challenging. Prior studies have shown that adults with SCI have body awareness deficits. Recent imaging studies, including ours, point to the parietal operculum and insula as key areas for both pain perception and body awareness. Cognitive multisensory rehabilitation (CMR) is a physical therapy approach that helps improve body awareness for pain reduction and sensorimotor recovery. Based on our prior brain imaging work in CMR in stroke, we hypothesized that improving body awareness through restoring parietal operculum network connectivity leads to neuropathic pain relief and improved sensorimotor and daily life function in adults with SCI. Thus, the objectives of this study were to (1) determine baseline differences in resting-state and task-based functional magnetic resonance imaging (fMRI) brain function in adults with SCI compared to healthy controls and (2) identify changes in brain function and behavioral pain and pain-associated outcomes in adults with SCI after CMR. Methods: Healthy adults underwent a one-time MRI scan and completed questionnaires. We recruited community-dwelling adults with SCI-related neuropathic pain, with complete or incomplete SCI >3 months, and highest neuropathic pain intensity level of >3 on the Numeric Pain Rating Scale (NPRS). Participants with SCI were randomized into two groups, according to a delayed treatment arm phase I randomized controlled trial (RCT): Group A immediately received CMR intervention, 3x/week, 45 min/session, followed by a 6-week and 1-year follow-up. Group B started with a 6-week observation period, then 6 weeks of CMR, and a 1-year follow-up. Highest, average, and lowest neuropathic pain intensity levels were assessed weekly with the NPRS as primary outcome. Other primary outcomes (fMRI resting-state and functional tasks; sensory and motor function with the INSCI AIS exam), as well as secondary outcomes (mood, function, spasms, and other SCI secondary conditions), were assessed at baseline, after the first and second 6-week period. The INSCI AIS exam and questionnaires were repeated at the 1-year follow-up. Findings: Thirty-six healthy adults and 28 adults with SCI were recruited between September 2020 and August 2021, and of those, 31 healthy adults and 26 adults with SCI were enrolled in the study. All 26 participants with SCI completed the intervention and pre-post assessments. There were no study-related adverse events. Participants were 52±15 years of age, and 1-56 years post-SCI. During the observation period, group B did not show any reductions in neuropathic pain and did not have any changes in sensation or motor function (INSCI ASIA exam). However, both groups experienced a significant reduction in neuropathic pain after the 6-week CMR intervention. Their highest level of neuropathic pain of 7.81±1.33 on the NPRS at baseline was reduced to 2.88±2.92 after 6 weeks of CMR. Their change scores were 4.92±2.92 (large effect size Cohen's d =1.68) for highest neuropathic pain, 4.12±2.23 ( d =1.85) for average neuropathic pain, and 2.31±2.07 ( d =1.00) for lowest neuropathic pain. Nine participants out of 26 were pain-free after the intervention (34.62%). The results of the INSCI AIS testing also showed significant improvements in sensation, muscle strength, and function after 6 weeks of CMR. Their INSCI AIS exam increased by 8.81±5.37 points ( d =1.64) for touch sensation, 7.50±4.89 points ( d =1.53) for pin prick sensation, and 3.87±2.81 ( d =1.38) for lower limb muscle strength. Functional improvements after the intervention included improvements in balance for 17 out of 18 participants with balance problems at baseline; improved transfers for all of them and a returned ability to stand upright with minimal assistance in 12 out of 20 participants who were unable to stand at baseline. Those improvements were maintained at the 1-year follow-up. With regard to brain imaging, we confirmed that the resting-state parietal operculum and insula networks had weaker connections in adults with SCI-related neuropathic pain (n=20) compared to healthy adults (n=28). After CMR, stronger resting-state parietal operculum network connectivity was found in adults with SCI. Also, at baseline, as expected, right toe sensory stimulation elicited less brain activation in adults with SCI (n=22) compared to healthy adults (n=26). However, after CMR, there was increased brain activation in relevant sensorimotor and parietal areas related to pain and mental body representations (i.e., body awareness and visuospatial body maps) during the toe stimulation fMRI task. These brain function improvements aligned with the AIS results of improved touch sensation, including in the feet. Interpretation: Adults with chronic SCI had significant neuropathic pain relief and functional improvements, attributed to the recovery of sensation and movement after CMR. The results indicate the preliminary efficacy of CMR for restoring function in adults with chronic SCI. CMR is easily implementable in current physical therapy practice. These encouraging impressive results pave the way for larger randomized clinical trials aimed at testing the efficacy of CMR to alleviate neuropathic pain in adults with SCI. Clinical Trial registration: ClinicalTrials.gov Identifier: NCT04706208. Funding: AIRP2-IND-30: Academic Investment Research Program (AIRP) University of Minnesota School of Medicine. National Center for Advancing Translational Sciences of the National Institutes of Health Award Number UL1TR002494; the Biotechnology Research Center: P41EB015894, the National Institute of Neurological Disorders & Stroke Institutional Center Core Grants to Support Neuroscience Research: P30 NS076408; and theHigh-Performancee Connectome Upgrade for Human 3T MR Scanner: 1S10OD017974.

Going Remote: A Revised Study Protocol for a Pilot Randomized Controlled Trial for Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury.

Background: The incidence of anxiety in adults with spinal cord injury/disorder (SCI/D) exceeds that of the general population. Heart rate variability (HRV) biofeedback training is a potential treatment associated with a reduction in stress and anxiety, however HRV training has not been explored in the SCI/D population. Objectives: To describe a modified protocol piloting HRV training to reduce anxiety associated with SCI/D and detail the COVID-19-related modifications. Methods: To test the feasibility of the biofeedback treatment, 30 adults with SCI/D will complete this pilot randomized controlled trial. Enrollment started in January 2020, halted in March 2020 due to the COVID-19 pandemic, and resumed in March 2021 with a modified protocol. Protocol modifications are documented using the Framework for Reporting Adaptations and Modifications (FRAME). Participants are allocated to the treatment or control arm and undergo eight sessions of physiological monitoring at home using a commercially available HRV sensor and mobile application, which also delivers biofeedback training for those in the treatment arm. Surveys are administered following each session to capture self-reported stress, anxiety, and mood. The study is approved by the HCA-HealthONE institutional review board and is registered with clinicaltrials.gov (NCT# 03975075). Conclusion: COVID-19 has changed the research landscape, forcing scientists to rethink their study designs to address patient and staff safety in this new context. Our modified protocol accomplished this by moving the treatment setting and delivery out of the clinic and into the home. In doing so, we address patient and staff safety, increase external validity, and reduce participant burden.