Cognitive-Behavioral-Based Physical Therapy for Improving Recovery After a Traumatic Lower-Extremity Injury: The Results of a Randomized Controlled Trial.

BACKGROUND: Lower-extremity injuries can result in severe impairment and substantial years lived with a disability. Persistent pain and psychological distress are risk factors for poor long-term outcomes and negatively influence the recovery process following a traumatic injury. Cognitive-behavioral therapy (CBT) interventions have the potential to address these risk factors and subsequently improve outcomes. This study aimed to evaluate the effect of a telephone-delivered cognitive-behavioral-based physical therapy (CBPT) program on physical function, pain, and general health at 12 months after hospital discharge following lower-extremity trauma. The CBPT program was hypothesized to improve outcomes compared with an education program. METHODS: A multicenter, randomized controlled trial was conducted involving 325 patients who were 18 to 60 years of age and had at least 1 acute orthopaedic injury to the lower extremity or to the pelvis or acetabulum requiring operative fixation. Patients were recruited from 6 Level-I trauma centers and were screened and randomized to the CBPT program or the education program early after hospital discharge. The primary outcome was the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) scale. The secondary outcomes were objective physical function tests (4-square step test, timed stair ascent test, sit-to-stand test, and self-selected walking speed test), PROMIS Pain Intensity and Pain Interference, and the Veterans RAND 12-Item Health Survey. Treatment effects were calculated using targeted maximum likelihood estimation, a robust analytical approach appropriate for causal inference with longitudinal data. RESULTS: The mean treatment effect on the 12-month baseline change in PROMIS PF was 0.94 (95% confidence interval, -0.68 to 2.64; p = 0.23). There were also no observed differences in secondary outcomes between the intervention group and the control group. CONCLUSIONS: The telephone-delivered CBPT did not appear to yield any benefits for patients with traumatic lower-extremity injuries in terms of physical function, pain intensity, pain interference, or general health. Improvements were observed in both groups, which questions the utility of telephone-delivered cognitive-behavioral strategies over educational programs. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

A Mind-Body Intervention to Improve Physical Activity for Patients with Chronic Hip-Related Pain: Protocol for a Mixed Methods Study.

BACKGROUND: Pain and dysfunction persist for most patients following hip-related pain treatment. Additionally, individuals with hip-related pain are typically less physically active than individuals without hip pain, despite evidence that regular physical activity reduces chronic musculoskeletal pain. Poor psychological health is common in patients with hip-related pain and further reinforces low physical activity. Mind-body interventions can improve psychological health and activity levels but have yet to be integrated to provide comprehensive, psychologically informed care for patients with hip-related pain. Thus, we are using the NCCIH intervention development framework to develop Helping Improve PSychological Health (HIPS), a novel, multimodal mind-body intervention to improve physical activity for individuals with hip-related pain and poor psychological health. METHODS: We will recruit physical therapists (N = 20) and patients with hip-related pain (N = 20) to participate in 60 min qualitative interviews (focus groups with therapists; one-on-one interviews with patients). Using these data, we will develop the initial HIPS intervention and provider training materials. One physical therapist will be trained to deliver the HIPS intervention to five participants in an open pilot trial. Participants will attend six 30 min HIPS intervention sessions. We will collect quantitative data on satisfaction, improvement, and physical activity, alongside qualitative exit interviews with participants and the physical therapist in order to refine the HIPS intervention and provider training materials. RESULTS: This study has been approved by the MGB IRB. We aim to develop and test the initial feasibility of the HIPS intervention in an open pilot trial. The findings from this project will inform a subsequent feasibility RCT.

The Combined Influence of Sleep Disturbance and Depression on 12-month Outcomes after Lumbar Spine Surgery.

STUDY DESIGN: Retrospective analysis of prospectively collected data. OBJECTIVE: To examine the combined influence of preoperative sleep disturbance and depression on 12-month patient-reported outcomes after lumbar spine surgery (LSS). SUMMARY OF BACKGROUND DATA: Psychological and behavioral factors are considered major risk factors of poor outcome after LSS. However, there is a need to explore the combined effects of preoperative factors such as sleep disturbance and depression. Understanding the influence of sleep disturbance and depression can inform evidence-based preoperative assessment and shared-decision making of preoperative and postoperative treatment. METHODS: Data from 700 patients undergoing LSS were analyzed. Preoperative sleep disturbance and depression were assessed with PROMIS subscales. Established thresholds defined patients with moderate/severe symptoms. Outcomes for disability (Oswestry Disability Index) and back and leg pain (Numeric Rating Scales) were assessed preoperatively and at 12 months. Separate multivariable linear regressions examined the influence of each factor on 12-month outcomes with and without accounting for the other, and in combination as a 4-level variable: 1) moderate/severe sleep disturbance alone, 2) moderate/severe depression alone, 3) both moderate/severe sleep disturbance and depression, 4) no moderate/severe sleep disturbance or depression. RESULTS: Preoperative sleep disturbance and depression were associated with 12-month disability and pain (P<0.05). After accounting for depression, preoperative sleep disturbance remained associated with disability, while preoperative depression adjusting for sleep disturbance remained associated with all outcomes (P<0.05). Patients reporting both moderate/severe sleep disturbance and moderate/severe depression had 12.6 points higher disability and 1.5 points higher back and leg pain compared to patients without moderate/severe sleep disturbance or depression. CONCLUSION: The combination of sleep disturbance and depression impacts postoperative outcomes considerably. The high-risk group of patients with moderate/severe sleep disturbance and depression could benefit from targeted treatment strategies.

Impact of occupational characteristics on return to work for employed patients after elective cervical spine surgery.

OBJECTIVE: In a cohort of employed patients undergoing elective cervical spine surgery with an uncomplicated postoperative course, the authors sought to determine the demographic, functional, and occupational characteristics associated with return to work (RTW) following surgery. METHODS: A retrospective cohort study of prospectively collected data was undertaken of patients undergoing elective cervical spine surgery for degenerative disease in the Quality Outcomes Database. Study inclusion criteria were: 1) employed prior to surgery and planned to RTW, 2) no unplanned readmissions, 3) achieved 30% improvement on the Neck Disability Index (NDI), and 4) were satisfied with the surgical outcome at 3 or 12 months postoperatively. A multivariable Cox regression model was built using demographic, functional, operative, and occupational characteristic to predict time to RTW. RESULTS: Of 5110 included patients, 4788 (93.7%) returned to work within 12 months, with a median time of 35 (IQR 19-60) days. Patients who did RTW were significantly younger (51.3 ± 9.4 vs 55.8 ± 9.6 years, p < 0.001), more often underwent an anterior approach (85.8% vs 80.7%, p = 0.009), were significantly more privately insured (82.1% vs 64.0%, p < 0.001), and were less likely to have workers' disability insurance (6.7% vs 14.6%, p < 0.001) compared with patients who did not RTW. On multivariable Cox regression, demographic factors associated with a longer RTW were older age (hazard ratio [HR] 0.99, 95% CI 0.99-1.00, p < 0.001) and Black race (HR 0.71, 95% CI 0.62-0.81, p < 0.001). Male sex was associated with a shorter RTW time (HR 1.19, 95% CI 1.11-1.26, p < 0.001). Regarding baseline functional status, worse preoperative NDI (HR 0.99, 95% CI 0.99-0.99, p < 0.001) was associated with a longer RTW, whereas the absence of myelopathy was associated with a shorter RTW (HR 1.17, 95% CI 1.09-1.25, p < 0.001). Having a sedentary (HR 1.81, 95% CI 1.65-1.99, p < 0.001), light-intensity (HR 1.60, 95% CI 1.45-1.76, p < 0.001), and medium-intensity (HR 1.11, 95% CI 1.01-1.22, p = 0.037) occupation was associated with a shorter RTW time compared with a heavy-intensity occupation at any time point. Heavy-intensity occupations were independently the strongest predictor of longer RTW. Similar predictors of shorter RTW were found in a subanalysis of occupation intensity and among operative approaches used. CONCLUSIONS: Among patients undergoing elective degenerative cervical spine surgery who had favorable surgical outcomes and planned to RTW before surgery, 94% had a successful RTW. Age was the strongest predictor of lower odds of RTW. Regarding time to RTW, having a sedentary, light-intensity, or medium-intensity occupation was associated with a shorter RTW time compared with a heavy-intensity occupation. These findings highlight the importance of considering the demographic and occupational characteristics when predicting postoperative RTW in patients with satisfactory surgical outcomes.

Impact of Unplanned Readmission on Patient-Reported Outcomes After Cervical Spine Surgery: A National Study of 13 355 Patients.

BACKGROUND AND OBJECTIVES: Although risk factors for unplanned readmission after cervical spine surgery have been widely reported, less is known about how readmission itself affects patient-reported outcome measures (PROMs). Using the Quality Outcomes Database registry of patients undergoing elective cervical spine surgery, we sought to (1) determine the impact of unplanned readmission on PROMs and (2) compare the effect of specific readmission reasons on PROMs. METHODS: An observational study was performed using a multi-institution, retrospective registry for patients undergoing cervical spine surgery. The occurrence of 90-day unplanned readmission classified into medical, surgical, pain only, and no readmissions was the exposure variable. Outcome variables included 12-month PROMs of Neck Disability Index (NDI), Numeric Rating Scale (NRS)-neck/arm pain, EuroQol-5D (EQ-5D), and patient dissatisfaction. Multivariable models predicting each PROM were built using readmission reasons controlling for demographics, clinical characteristics, and preoperative PROMs. RESULTS: Data from 13 355 patients undergoing elective cervical spine surgery (82% anterior approach and 18% posterior approach) were analyzed. Unplanned readmission within 90 days of surgery occurred in 3.8% patients, including medical (1.6%), surgical (1.8%), and pain (0.3%). Besides medical reasons, wound infection/dehiscence was the most common reason for unplanned readmission for the total cohort (0.5%), dysphagia in the anterior approach (0.6%), and wound infection/dehiscence in the posterior approach (1.5%). Based on multivariable regression, surgical readmission was significantly associated with worse 12-month NDI, NRS-neck pain, NRS-arm pain, EQ-5D, and higher odds of dissatisfaction. Pain readmissions were associated with worse 12-month NDI and NRS-neck pain scores, and worse dissatisfaction. For specific readmission reasons, pain, surgical site infection/wound dehiscence, hematoma/seroma, revision surgery, deep vein thrombosis, and pulmonary embolism were significantly associated with worsened 12-month PROMs. CONCLUSION: In patients undergoing elective cervical spine surgery, 90-day unplanned surgical and pain readmissions were associated with worse 12-month PROMs compared with patients with medical readmissions and no readmissions.

How many sites should an orthopedic trauma prospective multicenter trial have? A marginal analysis of the Major Extremity Trauma Research Consortium completed trials.

BACKGROUND: Multicenter trials in orthopedic trauma are costly, yet crucial to advance the science behind clinical care. The number of sites is a key cost determinant. Each site has a fixed overhead cost, so more sites cost more to the study. However, more sites can reduce total costs by shortening the study duration. We propose to determine the optimal number of sites based on known costs and predictable site enrollment. METHODS: This retrospective marginal analysis utilized administrative and financial data from 12 trials completed by the Major Extremity Trauma Research Consortium. The studies varied in size, design, and clinical focus. Enrollment across the studies ranged from 1054 to 33 patients. Design ranged from an observational study with light data collection to a placebo-controlled, double-blinded, randomized controlled trial. Initial modeling identified the optimal number of sites for each study and sensitivity analyses determined the sensitivity of the model to variation in fixed overhead costs. RESULTS: No study was optimized in terms of the number of participating sites. Excess sites ranged from 2 to 39. Excess costs associated with extra sites ranged from $17K to $330K with a median excess cost of $96K. Excess costs were, on average, 7% of the total study budget. Sensitivity analyses demonstrated that studies with higher overhead costs require more sites to complete the study as quickly as possible. CONCLUSIONS: Our data support that this model may be used by clinical researchers to achieve future study goals in a more cost-effective manner. TRIAL REGISTRATION: Please see Table 1 for individual trial registration numbers and dates of registration.

Impact of Racial/Ethnic Disparities on Patient Reported Outcomes Following Cervical Spine Surgery: QOD Analysis.

STUDY DESIGN: Retrospective analysis of data from the cervical module of a national spine registry, the Quality Outcomes Database (QOD). OBJECTIVE: To examine the association of race and ethnicity with patient-reported outcome measures (PROMs) at 1 year after cervical spine surgery. SUMMARY OF BACKGROUND DATA: Evidence suggests that Black individuals are 39% to 44% more likely to have postoperative complications and prolonged length of stay after cervical spine surgery compared to Whites. The long-term recovery assessed with PROMs after cervical spine surgery among Black, Hispanic and other non-Hispanic groups (i.e., Asian) remains unclear. METHODS: PROMs were used to assess disability (NDI) and neck/arm pain preoperatively and 1-year postoperative. Primary outcomes were disability and pain, and not being satisfied from pre-operative to 12-months after surgery. Multivariable logistic and proportional odds regression analyses were used to determine the association of racial/ethnic groups (Hispanic, non-Hispanic White (NHW), non-Hispanic Black (NHB), and non-Hispanic Asian (NHA)) with outcomes after covariate adjustment and to compute the odds of each racial/ethnic group achieving MCID 1-year postoperatively. RESULTS: Of the 14,429 participants, all had significant reductions in pain and disability, and 87% were satisfied at 1-year follow-up. Hispanic and NHB patients had higher odds of not being satisfied (40% and 80%) and having worse pain outcomes (30% to 70%) compared to NHW. NHB had 50% higher odds of worse disability scores compared to NHW. NHA reported similar disability and neck pain outcomes compared to NHW. CONCLUSIONS: Hispanic and non-Hispanic Black patients had worse patient-reported outcomes 1-year after cervical spine surgery compared to non-Hispanic White individuals, even after adjusting for potential confounders, yet there was no difference in disability and neck pain outcomes reported for non-Hispanic Asian patients. This study highlights the need to address inherent racial/ethnic disparities in recovery trajectories following cervical spine surgery. LEVEL OF EVIDENCE: 3.

Combining Wearable Technology and Telehealth Counseling for Rehabilitation After Lumbar Spine Surgery: Feasibility and Acceptability of a Physical Activity Intervention.

OBJECTIVE: The purpose of this study was to examine the feasibility and acceptability of a wearable device and telehealth counseling physical activity intervention early after lumbar spine surgery. METHODS: Sixteen patients were randomized to an 8-session physical activity intervention or to usual postoperative care after surgery. The intervention included a wearable device (ie, Fitbit) and telehealth counseling by a licensed physical therapist. The feasibility of study procedures was assessed through recruitment, randomization, retention, and participation rates. Acceptability was assessed through a satisfaction survey and median within-participant change in objective physical activity (steps per day and time spent in moderate-to-vigorous physical activity [MVPA]) and patient-reported outcomes. RESULTS: Of 64 participants who were eligible, recruitment and randomization rates were 41 and 62%, respectively. Retention for objective physical activity and patient-reported outcomes was 94 and 100%, respectively, at 6-month follow-up. Seven (88%) participants in the intervention group completed all telehealth sessions, and 6 (75%) met step goals over the 8 sessions. All participants in the intervention group found the wearable device and telehealth counseling to be helpful and reported it much or somewhat more important than other postoperative services. Median within-participant change for steps per day improved from baseline (preoperative) to 6 months after surgery for both the intervention (1070) and usual care (679) groups, while MVPA only improved for the intervention group (2.2. minutes per day). Improvements in back and leg pain and disability were noted for both groups. No adverse events were reported in the study. CONCLUSION: Combining wearable technology and telehealth counseling is a feasible approach to promote the physical activity during the early postoperative period after spine surgery. Future randomized controlled trials are needed to investigate the efficacy of leveraging wearables and telehealth during postoperative rehabilitation. IMPACT: This study has implications for the clinical dissemination of physical activity strategies in the rehabilitation setting.

Design of a Multicenter Randomized Controlled Trial comparing the effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for voluntary opioid tapering: The INSPIRE study protocol.

BACKGROUND: This paper describes the design and protocol of a pragmatic, randomized trial to evaluate the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Integrated Services for Pain: Interventions to Reduce Pain Effectively (INSPIRE) is a multicenter, randomized trial conducted at three academic health centers in the southeastern United States. Participants are adults receiving long-term opioid therapy of at least 20 morphine milligram equivalents daily for chronic noncancer pain. METHODS: Participants were randomized to either the shared decision-making intervention or the motivational interviewing session and cognitive behavioral therapy for chronic pain intervention. All participants also received guideline-concordant care supporting opioid pharmacotherapy. The primary outcome was change from baseline in average daily prescribed opioid dose at 12 months, using prescribing data from electronic health records. Secondary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference and Physical Function at 12 months. CONCLUSION: This trial evaluates the comparative effectiveness of shared decision making versus motivational interviewing plus cognitive behavioral therapy for chronic pain for the voluntary tapering of opioid dose in adults with chronic noncancer pain. Results from this study can guide clinicians, researchers, and policymakers as they seek to reduce opioid prescribing and improve management of chronic pain. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov Identifier: NCT03454555 (https://clinicaltrials.gov/ct2/show/record/NCT03454555). Participant enrollment began on June 26, 2019.

Performance of the streamlined quality outcomes database web-based calculator: internal and external validation.

BACKGROUND CONTEXT: With an increasing number of web-based calculators designed to provide the probabilities of an individual achieving improvement after lumbar spine surgery, there is a need to determine the accuracy of these models. PURPOSE: To perform an internal and external validation study of the reduced Quality Outcomes Database web-based Calculator (QOD-Calc). STUDY DESIGN: Observational longitudinal cohort. PATIENT SAMPLE: Patients enrolled study-wide in Quality Outcomes Database (QOD) and patients enrolled in DaneSpine at a single institution who had elective lumbar spine surgery with baseline data to complete QOD-Calc and 12-month postoperative data. OUTCOME MEASURES: Oswestry Disability Index (ODI), Numeric Rating Scales (NRS) for back and leg pain, EuroQOL-5D (EQ-5D). METHODS: Baseline data elements were entered into QOD-Calc to determine the probability for each patient having Any Improvement and 30% Improvement in NRS leg pain, back pain, EQ-5D and ODI. These probabilities were compared with the actual 12-month postop data for each of the QOD and DaneSpine cases. Receiver-operating characteristics analyses were performed and calibration plots created to assess model performance. RESULTS: 24,755 QOD cases and 8,105 DaneSpine lumbar cases were included in the analysis. QOD-Calc had acceptable to outstanding ability (AUC: 0.694-0.874) to predict Any Improvement in the QOD cohort and moderate to acceptable ability (AUC: 0.658-0.747) to predict 30% Improvement. QOD-Calc had acceptable to exceptional ability (AUC: 0.669-0.734) to predict Any improvement and moderate to exceptional ability (AUC: 0.619-0.862) to predict 30% Improvement in the DaneSpine cohort. AUCs for the DaneSpine cohort was consistently lower that the AUCs for the QOD validation cohort. CONCLUSION: QOD-Calc performs well in predicting outcomes in a patient population that is similar to the patients that was used to develop it. Although still acceptable, model performance was slightly worse in a distinct population, despite the fact that the sample was more homogenous. Model performance may also be attributed to the low discrimination threshold, with close to 90% of cases reporting Any Improvement in outcome. Prediction models may need to be developed that are highly specific to the characteristics of the population.

Impact of unplanned readmissions on lumbar surgery outcomes: a national study of 33,447 patients.

BACKGROUND CONTEXT: Unplanned readmissions following lumbar spine surgery have immense clinical and financial implications. However, little is known regarding the impact of unplanned readmissions on patient-reported outcomes (PROs) following lumbar spine surgery. PURPOSE: To evaluate the impact of unplanned readmissions, including specific readmission reasons, on patient reported outcomes 12 months after lumbar spine surgery. STUDY DESIGN/SETTING: A retrospective cohort study of prospectively collected data was conducted using patients included in the lumbar module of the Quality and Outcomes Database (QOD), a national, multicenter spine registry. PATIENT SAMPLE: A total of 33,447 patients who underwent elective lumbar spine surgery for degenerative diseases were included. Mean age was 59.8 (SD=14.04), 53.6% were male, 89.5% were white, 45.9% were employed, and 47.5% had private insurance. OUTCOME MEASURES: Unplanned 90-day readmissions and 12-month patient-reported outcomes (PROs) including numeric rating scale (NRS) scores for back and leg pain, Oswestry Disability Index (ODI) scores, EuroQol-5 Dimension (EQ-5D) scores, and North American Spine Society (NASS) patient-satisfaction scores. METHODS: The lumbar module of the QOD was queried for adults undergoing elective lumbar spine surgery for degenerative disease. Unplanned 90-day readmissions were classified into 4 groups: medical, surgical, pain-only, and no readmissions. Medical and surgical readmissions were further categorized into primary reason for readmission. 12-month PROs assessing patient back and leg pain (NRS), disability (ODI), quality of life (EQ-5D), and patient satisfaction were collected. Multivariable models predicting 12-month PROs were built controlling for covariates. RESULTS: A total of 31,430 patients (94%) had no unplanned readmission while 2,017 patients (6%) had an unplanned readmission within 90 days following lumbar surgery. Patients with readmissions had significantly worse 12-month PROs compared with those with no unplanned readmissions in covariate-adjusted models. Using Wald-df as a measure of predictor importance, surgical readmissions were associated with the worst 12-month outcomes, followed by pain-only, then medical readmissions. In separate covariate adjusted models, we found that readmissions for pain, SSI/wound dehiscence, and revisions were among the most important predictors of worse outcomes at 12-months. CONCLUSIONS: Unplanned 90-day readmissions were associated with worse pain, disability, quality of life, and greater dissatisfaction at 12-months, with surgical readmissions having the greatest impact, followed by pain-only readmissions, then medical readmissions. Readmissions for pain, SSI/wound dehiscence, and revisions were the most important predictors of worse outcomes. These results may help providers better understand the factors that impact outcomes following lumbar spine surgery and promote improved patient counseling and perioperative management.

Leveraging web-based prediction calculators to set patient expectations for elective spine surgery: a qualitative study to inform implementation.

BACKGROUND: Prediction calculators can help set outcomes expectations following orthopaedic surgery, however effective implementation strategies for these tools are unknown. This study evaluated provider and patient perspectives on clinical implementation of web-based prediction calculators developed using national prospective spine surgery registry data from the Quality Outcomes Database. METHODS: We conducted semi-structured interviews in two health systems, Vanderbilt University Medical Center (VUMC) and Duke University Health System (DUHS) of orthopedic and neurosurgery health care providers (VUMC: n = 19; DUHS: n = 6), health care administrators (VUMC: n = 9; DUHS: n = 9), and patients undergoing elective spine surgery (VUMC: n = 16). Qualitative template analysis was used to analyze interview data, with a focus on end-user perspectives regarding clinical implementation of web-based prediction tools. RESULTS: Health care providers, administrators and patients overwhelmingly supported the use of the calculators to help set realistic expectations for surgical outcomes. Some clinicians had questions about the validity and applicability of the calculators in their patient population. A consensus was that the calculators needed seamless integration into clinical workflows, but there was little agreement on best methods for selecting which patients to complete the calculators, timing, and mode of completion. Many interviewees expressed concerns that calculator results could influence payers, or expose risk of liability. Few patients expressed concerns over additional survey burden if they understood that the information would directly inform their care. CONCLUSIONS: Interviewees had a largely positive opinion of the calculators, believing they could aid in discussions about expectations for pain and functional recovery after spine surgery. No single implementation strategy is likely to be successful, and strategies vary, even within the same healthcare system. Patients should be well-informed of how responses will be used to deliver better care, and concerns over how the calculators could impact payment and liability should be addressed prior to use. Future research is necessary to determine whether use of calculators improves management and outcomes for people seeking a surgical consult for spine pain.

Protocol for a Parallel Group Randomized Clinical Trial Comparing a Culturally Adapted Cognitive Behavioral Telerehabilitation Intervention to Usual Physical Therapy for Latino Patients With Chronic Spine Pain.

OBJECTIVE: Disparities exist in health care access, diagnosis, and treatment of chronic pain in Latino populations and other minority populations. Cognitive behavioral-based physical therapy (CBPT) interventions have been shown to be effective in predominantly non-Hispanic white populations with chronic spine pain. However, there is a need for culturally adapted CBPT interventions that focus on the conservative management of chronic spine pain. The primary purpose of the study described in this protocol is to test the efficacy of an adapted cognitive behavioral-based hybrid telerehabilitation intervention for Latino patients with chronic spine pain. METHODS: A single-blind, 2-arm parallel group, superiority randomized clinical trial is planned to compare an adapted CBPT intervention to Usual Care physical therapy. Goal Oriented Activity for Latinos with chronic Spine pain (GOALS/Metas) is an 8-week hybrid telerehabilitation intervention that integrates guideline-based physical therapy and pain management interventions using cognitive behavioral approaches and has been adapted for Latino patients with chronic spine pain. Usual Care physical therapy will be administered based on institutional standards at the referring health center. Outcome measures will be evaluated preintervention and at 1-week, 3-months, and 6-months postintervention. The primary outcome is pain-related disability 1-week postintervention using the Brief Pain Inventory Pain Interference subscale. Secondary outcome measures include behavioral measures of functional activity, social participation, physical activity, and sleep. Determinants of treatment effect, including pain-related psychological measures, posture and movement, self-efficacy, treatment expectancy, and therapeutic alliance, will be included in the secondary moderation and mediation analyses. IMPACT: This clinical trial will provide information on the extent to which an adapted CBPT hybrid telerehabilitation intervention is effective in reducing pain-related disability for Latino patients with chronic spine pain. This information will be useful for clinicians to integrate in their practice, given the growing population of Latino patients who experience disparities in health care management of chronic pain.

A clinical model to predict postoperative improvement in sub-domains of the modified Japanese Orthopedic Association score for degenerative cervical myelopathy.

PURPOSE: The modified Japanese Orthopedic Association (mJOA) score consists of six sub-domains and is used to quantify the severity of cervical myelopathy. The current study aimed to assess for predictors of postoperative mJOA sub-domains scores following elective surgical management for patients with cervical myelopathy and develop the first clinical prediction model for 12-month mJOA sub-domain scores.Please confirm if the author names are presented accurately and in the correct sequence (given name, middle name/initial, family name). Author 1 Given name: [Byron F.] Last name [Stephens], Author 2 Given name: [Lydia J.] Last name [McKeithan], Author 3 Given name: [W. Hunter] Last name [Waddell], Author 4 Given name: [Anthony M.] Last name [Steinle], Author 5 Given name: [Wilson E.] Last name [Vaughan], Author 6 Given name: [Jacquelyn S.] Last name [Pennings], Author 7 Given name: [Jacquelyn S.] Last name [Pennings], Author 8 Given name: [Scott L.] Last name [Zuckerman], Author 9 Given name: [Kristin R.] Last name [Archer], Author 10 Given name: [Amir M.] Last name [Abtahi] Also, kindly confirm the details in the metadata are correct.Last Author listed should be Kristin R. Archer METHODS: A multivariable proportional odds ordinal regression model was developed for patients with cervical myelopathy. The model included patient demographic, clinical, and surgery covariates along with baseline sub-domain scores. The model was internally validated using bootstrap resampling to estimate the likely performance on a new sample of patients. RESULTS: The model identified mJOA baseline sub-domains to be the strongest predictors of 12-month scores, with numbness in legs and ability to walk predicting five of the six mJOA items. Additional covariates predicting three or more items included age, preoperative anxiety/depression, gender, race, employment status, duration of symptoms, smoking status, and radiographic presence of listhesis. Surgical approach, presence of motor deficits, number of surgical levels involved, history of diabetes mellitus, workers' compensation claim, and patient insurance had no impact on 12-month mJOA scores. CONCLUSION: Our study developed and validated a clinical prediction model for improvement in mJOA scores at 12 months following surgery. The results highlight the importance of assessing preoperative numbness, walking ability, modifiable variables of anxiety/depression, and smoking status. This model has the potential to assist surgeons, patients, and families when considering surgery for cervical myelopathy. LEVEL OF EVIDENCE: Level III.

Orthopedic surgeons and physical therapists differ regarding rehabilitative needs after lower extremity fracture repair.

BACKGROUND: Little evidence is available to guide physical therapy (PT) following lower extremity fracture repair distal to the hip. As such, variability has been reported in the way PT is utilized post-operatively. Examination of current practice by orthopedic surgeons (OS) and physical therapists is needed to inform clinical practice guidelines in this area. OBJECTIVE: To describe current PT referral practices among OS, identify patient and clinical factors that affect PT referral, and examine differences between OS and physical therapists with regard to visit frequency, duration, and use of specific PT interventions. METHODS: Provider surveys. RESULTS: Surveys were completed by 100 OS and 347 physical therapists. Over half (54%) of OS reported referring "most patients" to PT and identified joint stiffness and strength limitations as top reasons for PT referral. Over 80% of OS and physical therapists indicated that joint stiffness, strength limitations, and patients' functional goals affected their recommendations for PT visit frequency. More physical therapists than OS reported that pain severity (55% vs 25%, p < .001), maladaptive pain behaviors (64% vs. 33%, p < .001), and patient self-efficacy (70% vs. 49%, p = .003) affected their visit frequency recommendations. While OS recommended more frequent PT for patients with peri-articular fractures, fracture type had minimal impact on the visit frequencies recommended by physical therapists. CONCLUSION: OS and physical therapists consider similar physical impairments when determining the need for PT and visit frequencies, however, physical therapists consider pain and psychosocial factors more often, with OS focusing more on injury type.

A Conceptual Model for Spine Surgery Recovery: A Qualitative Study of Patients' Expectations, Experiences, and Satisfaction.

STUDY DESIGN: Qualitative interview study. OBJECTIVE: The aim was to develop a conceptual model for Spine Surgery Recovery in order to better understand why patients undergo lumbar spine surgery and what factors influence patient satisfaction. SUMMARY OF BACKGROUND DATA: Quantitative studies have assessed patients' expectations for lumbar spine surgery outcomes, with greater expectation fulfillment leading to higher satisfaction. However, there is limited literature using qualitative methods to understand the patient perspective from the decision to undergo lumbar spine surgery through long-term recovery. MATERIALS AND METHODS: Semistructured phone interviews were conducted with 20 participants (nine females, mean age ±SD=61.2±11.1 yr) and three focus groups with 12 participants (nine females, mean age ±SD=62.0±10.9 yr). Sessions were audio recorded and transcribed. Two independent researchers coded the transcripts using a hierarchical coding system. Major themes were identified and a conceptual model was developed. RESULTS: A total of 1355 coded quotes were analyzed. The decision to have lumbar spine surgery was influenced by chronic pain impact on daily function, pain coping, and patient expectations. Results demonstrated that fulfilled expectations and setting realistic expectations are key factors for patient satisfaction after surgery, while less known constructs of accepting limitations, adjusting expectations, and optimism were found by many patients to be essential for a successful recovery. Emotional factors of fear, anxiety, and depression were important aspects of presurgical and postsurgical experiences. CONCLUSION: Our Spine Surgery Recovery conceptual model provides guidance for future research and clinical practice to optimize treatment and improve overall patient satisfaction. Recommendations based on this model include the assessment of patient expectations and mental well-being throughout postoperative recovery as well as preoperatively to help set realistic expectations and improve satisfaction. Educational, acceptance-based or positive psychological interventions may be potentially beneficial for addressing key factors identified in this model.

Effect of a Biopsychosocial Intervention or Postural Therapy on Disability and Health Care Spending Among Patients With Acute and Subacute Spine Pain: The SPINE CARE Randomized Clinical Trial.

Importance: Low back and neck pain are often self-limited, but health care spending remains high. Objective: To evaluate the effects of 2 interventions that emphasize noninvasive care for spine pain. Design, Setting, and Participants: Pragmatic, cluster, randomized clinical trial conducted at 33 centers in the US that enrolled 2971 participants with neck or back pain of 3 months' duration or less (enrollment, June 2017 to March 2020; final follow-up, March 2021). Interventions: Participants were randomized at the clinic-level to (1) usual care (n = 992); (2) a risk-stratified, multidisciplinary intervention (the identify, coordinate, and enhance [ICE] care model that combines physical therapy, health coach counseling, and consultation from a specialist in pain medicine or rehabilitation) (n = 829); or (3) individualized postural therapy (IPT), a postural therapy approach that combines physical therapy with building self-efficacy and self-management (n = 1150). Main Outcomes and Measures: The primary outcomes were change in Oswestry Disability Index (ODI) score at 3 months (range, 0 [best] to 100 [worst]; minimal clinically important difference, 6) and spine-related health care spending at 1 year. A 2-sided significance threshold of .025 was used to define statistical significance. Results: Among 2971 participants randomized (mean age, 51.7 years; 1792 women [60.3%]), 2733 (92%) finished the trial. Between baseline and 3-month follow-up, mean ODI scores changed from 31.2 to 15.4 for ICE, from 29.3 to 15.4 for IPT, and from 28.9 to 19.5 for usual care. At 3-month follow-up, absolute differences compared with usual care were -5.8 (95% CI, -7.7 to -3.9; P < .001) for ICE and -4.3 (95% CI, -5.9 to -2.6; P < .001) for IPT. Mean 12-month spending was $1448, $2528, and $1587 in the ICE, IPT, and usual care groups, respectively. Differences in spending compared with usual care were -$139 (risk ratio, 0.93 [95% CI, 0.87 to 0.997]; P = .04) for ICE and $941 (risk ratio, 1.40 [95% CI, 1.35 to 1.45]; P < .001) for IPT. Conclusions and Relevance: Among patients with acute or subacute spine pain, a multidisciplinary biopsychosocial intervention or an individualized postural therapy intervention, each compared with usual care, resulted in small but statistically significant reductions in pain-related disability at 3 months. However, compared with usual care, the biopsychosocial intervention resulted in no significant difference in spine-related health care spending and the postural therapy intervention resulted in significantly greater spine-related health care spending at 1 year. Trial Registration: ClinicalTrials.gov Identifier: NCT03083886.

Technology-Enhanced Delivery Models to Facilitate the Implementation of Psychologically Informed Practice for Chronic Musculoskeletal Pain.

Chronic musculoskeletal pain is prevalent, challenging to treat, and often disabling. Evidence supports the role of psychological factors in pain-related outcomes, and it is now accepted that rehabilitation should combine physical and psychological approaches (ie, psychologically informed practice). This Perspective articulates a vision for technology-enhanced psychologically informed practice for chronic musculoskeletal pain, highlights relevant research evidence, discusses how technology can circumvent implementation barriers, and proposes directions for future research.

Assessing the Insurance Deductible Effect on Outcomes After Elective Spinal Surgery.

BACKGROUND: Private insurers use the calendar deductible system, placing pressure on patients and medical personnel to perform medical services before the end of the year to maximize patient savings. The impact of the deductible calendar on patient-reported outcomes (PROs) after spine surgery is poorly understood. The objective of our study was to investigate if patients undergoing surgery in December had different PROs and demographics compared with all other months. METHODS: The Quality Outcome Database, a national spine registry, was queried for patients who underwent elective spine surgery between January 2012 and January 2021 for degenerative spine conditions. PROs and demographics were compared between the December and non-December groups using various statistical tests. RESULTS: A total of 978 patients (9.3%) underwent anterior cervical discectomy and fusion in December versus 9548 (90.7%) in other months. There was a significantly higher percentage of patients in December who had private insurance and were employed. A total of 1104 patients (8.5%) underwent lumbar fusion in December versus 11,826 (91.5%) in other months. There was a significantly greater chance of undergoing surgery in December if patients had private insurance and were employed. Although some PROs were statistically significant for the lumbar and cervical cohorts between December and non-December patients, none were clinically significant. CONCLUSIONS: Patients undergoing elective spine surgery in December were more likely to have private insurance and be employed. PROs for ACDF and lumbar fusions were not affected by surgical timing (December yes/no). Other spinal procedures directed at more chronic diseases might be more susceptible to external influence of insurance deductibles.