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.

Patient-Centered Goals After Lumbar Spine Surgery: A Secondary Analysis of Cognitive-Behavioral-Based Physical Therapy Outcomes From a Randomized Controlled Trial.

OBJECTIVE: The purpose of this study was to examine the association between goal attainment and patient-reported outcomes in patients who engaged in a 6-session, telephone-based, cognitive-behavioral-based physical therapy (CBPT) intervention after spine surgery. METHODS: In this secondary analysis of a randomized trial, data from 112 participants (mean age = 63.3 [SD = 11.2] years; 57 [51%] women) who attended at least 2 CBPT sessions (median = 6 [range = 2-6]) were examined. At each session, participants set weekly goals and used goal attainment scaling (GAS) to report goal attainment from the previous session. The number and type of goals and percentage of goals met were tracked. An individual GAS t score was computed across sessions. Participants were categorized based on goals met as expected (GAS t score ≥ 50) or goals not met as expected (GAS t score < 50). Six- and 12-month outcomes included disability (Oswestry Disability Index), physical and mental health (12-Item Short-Form Health Survey), physical function (Patient-Reported Outcomes Measurement Information System), pain interference (Patient-Reported Outcomes Measurement Information System), and back and leg pain intensity (numeric rating scale). Outcome differences over time between groups were examined with mixed-effects regression. RESULTS: Participants set a median of 3 goals (range = 1-6) at each session. The most common goal categories were recreational/physical activity (36%), adopting a CBPT strategy (28%), exercising (11%), and performing activities of daily living (11%). Forty-eight participants (43%) met their goals as expected. Participants who met their goals as expected had greater physical function improvement at 6 months (estimate = 3.7; 95% CI = 1.0 to 6.5) and 12 months (estimate = 2.8; 95% CI = 0.04 to 5.6). No other outcome differences were noted. CONCLUSIONS: Goal attainment within a CBPT program was associated with 6- and 12-month improvements in postoperative physical functioning. IMPACT: This study highlights goal attainment as an important rehabilitation component related to physical function recovery after spine surgery.

Cognitive-Behavioral-Based Physical Therapy for Improving Recovery After Traumatic Orthopaedic Lower Extremity Injury (CBPT-Trauma).

SUMMARY: Physical and psychological impairment resulting from traumatic injuries is often significant and affects employment and functional independence. Extremity trauma has been shown to negatively affect long-term self-reported physical function, the ability to work, and participation in recreational activities and contributes to increased rates of anxiety and/or depression. High pain levels early in the recovery process and psychosocial factors play a prominent role in recovery after traumatic lower extremity injury. Cognitive-behavioral therapy pain programs have been shown to mitigate these effects. However, patient access issues related to financial and transportation constraints and the competing demands of treatment focused on the physical sequelae of traumatic injury limit patient participation in this treatment modality. This article describes a telephone-delivered cognitive-behavioral-based physical therapy (CBPT-Trauma) program and design of a multicenter trial to determine its effectiveness after lower extremity trauma. Three hundred twenty-five patients from 7 Level 1 trauma centers were randomized to CBPT-Trauma or an education program after hospital discharge. The primary hypothesis is that compared with patients who receive an education program, patients who receive the CBPT-Trauma program will have improved physical function, pain, and physical and mental health at 12 months after hospital discharge.

Composite psychosocial risk based on the fear avoidance model in patients undergoing anterior cruciate ligament reconstruction: Cluster-based analysis.

OBJECTIVES: To examine associations between preoperative fear-avoidance model (FAM) risk subgroup status and patient expectation of surgical success with postoperative outcomes at 6 and 12 months after anterior cruciate ligament reconstruction (ACLR). DESIGN: Cohort study. SETTING: Academic medical center. PARTICIPANTS: 54 patients (25 females) undergoing unilateral ACLR. MAIN OUTCOME MEASURES: Cluster analysis distinguished FAM risk subgroups based on preoperative fear of movement/reinjury, self-efficacy, and pain catastrophizing. Preoperative expectation for surgical success was assessed with a numeric rating scale. Six and 12-month outcomes included Subjective Patient Outcomes for Return to Sport, Knee Injury and Osteoarthritis Outcome Score (KOOS) sports/recreation and quality of life, and International Knee Documentation Committee (IKDC) Subjective Knee Form. RESULTS: Thirteen (24%) patients were "moderate-to-high FAM risk." Moderate-to-high FAM risk patients had lower odds of return to sport at 12 months (OR = 0.3, p = .05) and lower KOOS sports/recreation at 6 months (st. beta = -0.27, p = .05), KOOS quality of life at 12 months (st. beta = -0.42, p = .007), and IKDC at 6 (st. beta = -0.29, p = .04) and 12 months (st. beta = -0.47, p = .001). Higher expectation was associated with lower 6-month IKDC (st. beta = -0.36, p = .008) and 12-month KOOS quality of life (st. beta = -0.29, p = .05). CONCLUSIONS: Preoperative FAM risk influences patient-reported outcomes and return to sport at 6 and 12 months.

Safety and feasibility of an early telephone-supported home exercise program after anterior cervical discectomy and fusion: a case series.

Objective: To describe the safety, feasibility, and preliminary outcomes of an early telephone-supported home exercise program (HEP) performed within the first 6 weeks after anterior cervical discectomy and fusion (ACDF) surgery.Methods: Eight patients (mean ± SD age = 53.4 ± 14.9 years, 5 females) were enrolled in this case series. Immediately after surgery, patients began a 6-week HEP including daily walking, deep breathing, distraction techniques, and cervical and upper body exercises. The HEP was supported by weekly telephone calls by a physical therapist. Safety for performing early exercise was examined with radiographic imaging at 6 months. Adverse events were assessed through weekly calls with a physical therapist. HEP adherence and acceptability data were obtained by patient self-report. Clinical measures were assessed preoperatively, at 6 weeks and at 6 months, and included the Neck Disability Index, Numeric Rating Scale for pain, Tampa Scale of Kinesiophobia, Pain Catastrophizing Scale, Pain Self-Efficacy Questionnaire, and accelerometry for physical activity.Results: Early radiographic imaging showed no signs of nonunion at 6 months. There were no reports of serious adverse events. At 6 months, all patients reported clinically significant changes in pain catastrophizing. Seven (88%) patients had clinically significant changes in disability and arm pain, six (75%) patients for neck pain and pain self-efficacy, and five (53%) patients for fear of movement. Only three (43%) of seven patients showed increased physical activity at 6 months.Conclusion: Based on this small case series, an early telephone-supported HEP appears safe for patients, feasible to implement, and promising for clinical benefits.

Psychosocial Mechanisms of Cognitive-Behavioral-Based Physical Therapy Outcomes After Spine Surgery: Preliminary Findings From Mediation Analyses.

OBJECTIVE: Changing Behavior through Physical Therapy (CBPT), a cognitive-behavioral-based program, has been shown to improve outcomes after lumbar spine surgery in patients with a high psychosocial risk profile; however, little is known about potential mechanisms associated with CBPT treatment effects. The purpose of this study was to explore potential mediators underlying CBPT efficacy after spine surgery. METHODS: In this secondary analysis, 86 participants were enrolled in a randomized trial comparing a postoperative CBPT (n = 43) and education program (n = 43). Participants completed validated questionnaires at 6 weeks (baseline) and 3 and 6 months following surgery for back pain (Brief Pain Inventory), disability (Oswestry Disability Index), physical health (12-Item Short-Form Health Survey), fear of movement (Tampa Scale for Kinesiophobia), pain catastrophizing (Pain Catastrophizing Scale), and pain self-efficacy (Pain Self-Efficacy Questionnaire). Parallel multiple mediation analyses using Statistical Package for the Social Sciences (SPSS) were conducted to examine whether 3- and 6-month changes in fear of movement, pain catastrophizing, and pain self-efficacy mediate treatment outcome effects at 6 months. RESULTS: Six-month changes, but not 3-month changes, in fear of movement and pain self-efficacy mediated postoperative outcomes at 6 months. Specifically, changes in fear of movement mediated the effects of CBPT treatment on disability (indirect effect = -2.0 [95% CI = -4.3 to 0.3]), whereas changes in pain self-efficacy mediated the effects of CBPT treatment on physical health (indirect effect = 3.5 [95% CI = 1.2 to 6.1]). CONCLUSIONS: This study advances evidence on potential mechanisms underlying cognitive-behavioral strategies. Future work with larger samples is needed to establish whether these factors are a definitive causal mechanism. IMPACT: Fear of movement and pain self-efficacy may be important mechanisms to consider when developing and testing psychologically informed physical therapy programs.

Cognitive-behavioral-based physical therapy to enhance return to sport after anterior cruciate ligament reconstruction: An open pilot study.

OBJECTIVES: To describe feasibility, adherence, acceptability, and outcomes of a cognitive-behavioral-based physical therapy (CBPT-ACLR) intervention for improving postoperative recovery after anterior cruciate ligament reconstruction (ACLR). DESIGN: Pilot study. SETTING: Academic medical center. PARTICIPANTS: Eight patients (mean age [SD] = 20.1 [2.6] years, 6 females) participated in a 7-session telephone-based CBPT-ACLR intervention beginning preoperatively and lasting 8 weeks after surgery. MAIN OUTCOME MEASURES: At 6 months, patients completed Knee Injury and Osteoarthritis Outcome Score (KOOS) sports/recreation and quality of life (QOL) subscales, International Knee Documentation Committee (IKDC), Tampa Scale of Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS), and Knee Self-Efficacy Scale (K-SES), return to sport (Subjective Patient Outcome for Return to Sports), and satisfaction. Minimal clinically important difference (MCID) was used for meaningful change. RESULTS: Seven (88%) patients completed all sessions. Seven (88%) patients exceeded MCID on the TSK, 6 (75%) on the PCS, 5 (63%) on the KOOS sports/recreation subscale, 4 (50%) on the IKDC, and 3 (38%) on the KOOS QOL subscale. Three (38%) patients returned to their same sport at the same level of effort and performance. All patients were satisfied with their recovery. CONCLUSIONS: A CBPT-ACLR program is feasible and acceptable for addressing psychological risk factors after ACLR.

Early Self-directed Home Exercise Program After Anterior Cervical Discectomy and Fusion: A Pilot Study.

STUDY DESIGN: Pilot randomized controlled trial. OBJECTIVE: To examine the acceptability and preliminary safety and outcome effects of an early self-directed home exercise program (HEP) performed within the first 6 weeks after anterior cervical discectomy and fusion (ACDF). SUMMARY OF BACKGROUND DATA: Little is known regarding optimal postoperative management after ACDF. METHODS: Thirty patients (mean ±â€Šstandard deviation, age = 50.6 ±â€Š11.0 years, 16 women) undergoing ACDF were randomized to receive an early HEP (n = 15) or usual care (n = 15). The early HEP was a 6-week self-directed program with weekly supportive telephone calls to reduce pain and improve activity. Treatment acceptability was assessed after the intervention period (6 weeks after surgery). Safety (adverse events, radiographic fusion, revision surgery) was determined at routine postoperative visits. Disability (Neck Disability Index), pain intensity (Numeric Rating Scale for neck and arm pain), physical and mental health (SF-12), and opioid use were assessed preoperatively, and at 6 weeks and 6 and 12 months after surgery by an evaluator blinded to group assignment. RESULTS: Participants reported high levels of acceptability and no serious adverse events with the early HEP. No difference in fusion rate was observed between groups (P > 0.05) and no participants underwent revision surgery. The early self-directed HEP group reported lower 6-week neck pain than the usual care group (F = 3.3, P = 0.04, r = 0.3, mean difference = -1.7 [-3.4; -0.05]) and lower proportion of individuals (13% vs. 47%) using opioids at 12 months (P = 0.05). No other between-group outcome differences were observed (P > 0.05). CONCLUSION: An early self-directed HEP program was acceptable to patients and has the potential to be safely administered to patients immediately after ACDF. Benefits were noted for short-term neck pain and long-term opioid utilization. However, larger trials are needed to confirm safety with standardized and long-term radiograph assessment and treatment efficacy. LEVEL OF EVIDENCE: 2.

Association Between 6-Week Postdischarge Risk Classification and 12-Month Outcomes After Orthopedic Trauma.

Importance: Numerous studies have demonstrated that long-term outcomes after orthopedic trauma are associated with psychosocial and behavioral health factors evident early in the patient's recovery. Little is known about how to identify clinically actionable subgroups within this population. Objectives: To examine whether risk and protective factors measured at 6 weeks after injury could classify individuals into risk clusters and evaluate whether these clusters explain variations in 12-month outcomes. Design, Setting, and Participants: A prospective observational study was conducted between July 16, 2013, and January 15, 2016, among 352 patients with severe orthopedic injuries at 6 US level I trauma centers. Statistical analysis was conducted from October 9, 2017, to July 13, 2018. Main Outcomes and Measures: At 6 weeks after discharge, patients completed standardized measures for 5 risk factors (pain intensity, depression, posttraumatic stress disorder, alcohol abuse, and tobacco use) and 4 protective factors (resilience, social support, self-efficacy for return to usual activity, and self-efficacy for managing the financial demands of recovery). Latent class analysis was used to classify participants into clusters, which were evaluated against measures of function, depression, posttraumatic stress disorder, and self-rated health collected at 12 months. Results: Among the 352 patients (121 women and 231 men; mean [SD] age, 37.6 [12.5] years), latent class analysis identified 6 distinct patient clusters as the optimal solution. For clinical use, these clusters can be collapsed into 4 groups, sorted from low risk and high protection (best) to high risk and low protection (worst). All outcomes worsened across the 4 clinical groupings. Bayesian analysis shows that the mean Short Musculoskeletal Function Assessment dysfunction scores at 12 months differed by 7.8 points (95% CI, 3.0-12.6) between the best and second groups, by 10.3 points (95% CI, 1.6-20.2) between the second and third groups, and by 18.4 points (95% CI, 7.7-28.0) between the third and worst groups. Conclusions and Relevance: This study demonstrates that during early recovery, patients with orthopedic trauma can be classified into risk and protective clusters that account for a substantial amount of the variance in 12-month functional and health outcomes. Early screening and classification may allow a personalized approach to postsurgical care that conserves resources and targets appropriate levels of care to more patients.

Cognitive-Behavioral-Based Physical Therapy for Patients With Chronic Pain Undergoing Lumbar Spine Surgery: A Randomized Controlled Trial.

UNLABELLED: The purpose of this study was to determine the efficacy of a cognitive-behavioral-based physical therapy (CBPT) program for improving outcomes in patients after lumbar spine surgery. A randomized controlled trial was conducted on 86 adults undergoing a laminectomy with or without arthrodesis for a lumbar degenerative condition. Patients were screened preoperatively for high fear of movement using the Tampa Scale for Kinesiophobia. Randomization to either CBPT or an education program occurred at 6 weeks after surgery. Assessments were completed pretreatment, posttreatment and at 3-month follow-up. The primary outcomes were pain and disability measured by the Brief Pain Inventory and Oswestry Disability Index. Secondary outcomes included general health (SF-12) and performance-based tests (5-Chair Stand, Timed Up and Go, 10-Meter Walk). Multivariable linear regression analyses found that CBPT participants had significantly greater decreases in pain and disability and increases in general health and physical performance compared with the education group at the 3-month follow-up. Results suggest a targeted CBPT program may result in significant and clinically meaningful improvement in postoperative outcomes. CBPT has the potential to be an evidence-based program that clinicians can recommend for patients at risk for poor recovery after spine surgery. PERSPECTIVE: This study investigated a targeted cognitive-behavioral-based physical therapy program for patients after lumbar spine surgery. Findings lend support to the hypothesis that incorporating cognitive-behavioral strategies into postoperative physical therapy may address psychosocial risk factors and improve pain, disability, general health, and physical performance outcomes.

Telephone-based goal management training for adults with mild traumatic brain injury: study protocol for a randomized controlled trial.

BACKGROUND: Approximately 1 million individuals experience a mild traumatic brain injury (TBI) and cost the United States nearly $17 billion each year. Many trauma survivors with mild TBI have debilitating and long-term physical, emotional, and cognitive impairments that are unrecognized at trauma centers. Early intervention studies are needed to address these impairments, especially cognitive deficits in executive functioning. Goal management training (GMT) is a structured cognitive rehabilitation program that has been found to improve executive functioning in patients with moderate to severe TBI. The current study adapted the GMT program for telephone delivery in order to improve the accessibility of rehabilitation services in a patient population with multiple barriers to care and significant yet unrecognized cognitive impairment. The primary objective of this study is to examine the efficacy of telephone-based GMT for improving executive functioning, functional status, and psychological health in trauma survivors with mild TBI. METHODS/DESIGN: This study is a three-group randomized controlled trial being conducted at a Level I trauma center. Ninety trauma survivors with mild TBI and cognitive deficits in executive functioning will be randomized to receive telephone-based GMT, telephone-based education, or usual care. GMT and education programs will be delivered by a physical therapist. The first in-person session is 1 h and the remaining six telephone sessions are 30 min. A battery of well-established cognitive tests will be conducted and validated questionnaires will be collected that measure executive functioning, functional status, and depressive and posttraumatic stress disorder symptoms at 6 weeks, 4 months, and 7 months following hospital discharge. DISCUSSION: This study supports a telephone-delivery approach to rehabilitation services in order to broaden the availability of evidence-based cognitive strategies. TRIAL REGISTRATION: This trial was registered with Clinicaltrials.gov on 10 October 2012, registration number: NCT01714531.

A comparative effectiveness trial of postoperative management for lumbar spine surgery: changing behavior through physical therapy (CBPT) study protocol.

BACKGROUND: The United States has the highest rate of lumbar spine surgery in the world, with rates increasing over 200% since 1990. Medicare spends over $1 billion annually on lumbar spine surgery. Despite surgical advances, up to 40% of patients report chronic pain and disability following surgery. Our work has demonstrated that fear of movement is a risk factor for increased pain and disability and decreased physical function in patients following lumbar spine surgery for degenerative conditions. Cognitive-behavioral therapy and self-management treatments have the potential to address psychosocial risk factors and improve outcomes after spine surgery, but are unavailable or insufficiently adapted for postoperative care. Our research team developed a cognitive-behavioral based self-management approach to postoperative rehabilitation (Changing Behavior through Physical Therapy (CBPT)). Pilot testing of the CBPT program demonstrated greater improvement in pain, disability, physical and mental health, and physical performance compared to education. The current study compares which of two treatments provided by telephone - a CBPT Program or an Education Program about postoperative recovery - are more effective for improving patient-centered outcomes in adults following lumbar spine surgery for degenerative conditions. METHODS/DESIGN: A multi-center, comparative effectiveness trial will be conducted. Two hundred and sixty patients undergoing lumbar spine surgery for degenerative conditions will be recruited from two medical centers and community surgical practices. Participants will be randomly assigned to CBPT or Education at 6 weeks following surgery. Treatments consist of six weekly telephone sessions with a trained physical therapist. The primary outcome will be disability and secondary outcomes include pain, general health, and physical activity. Outcomes will be assessed preoperatively and at 6 weeks, 6 months and 12 months after surgery by an assessor masked to group allocation. DISCUSSION: Effective rehabilitation treatments that can guide clinicians in their recommendations, and patients in their actions will have the potential to effect change in current clinical practice. TRIAL REGISTRATION: NCT02184143.