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Archer K1, Skolasky R2, Coronado R1, Haug C3, Pennings J1, Vanston S1, Riley, III L2, Neuman B2, Cheng J4, Aaronson O5, Devin C1,6, Wegener S2
1Vanderbilt University Medical Center, Nashville, United States, 2Johns Hopkins Medicine, Baltimore, United States, 3Carolina Neurosurgery & Spine Associates, Charlotte, United States, 4University of Cincinnati College of Medicine, Cincinnati, United States, 5Howell Allen Clinic, Saint Thomas Partners, Nashville, United States, 6Orthopaedics of Steamboat Springs, Steamboat Springs, United States
Background: Studies have found that patient psychosocial characteristics are strongly related to surgical spine outcomes. Limited evidence exists on the potential benefit of physical therapist-delivered cognitive-behavioral therapy (CBT) treatments for patients following lumbar spine surgery.
Purpose: The purpose was to compare which of two treatments delivered by telephone - a CBT-based physical therapy program (CBPT) or an Education program - are more effective for improving patient-centered outcomes after lumbar spine surgery.
Methods: A multicenter randomized controlled trial was conducted at 2 medical centers (NCT02184143). 248 patients undergoing surgery for a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis were randomized into CBPT (n=124) or an attention-matched Education group (n=124). The primary patient-reported outcomes were disability (Oswestry Disability Index: ODI), pain intensity (Brief Pain Inventory), and physical and mental health (SF-12). A secondary outcome was observed physical activity which was assessed using accelerometers. Health care utilization was also recorded. Patient assessments occurred preoperatively and at 6 weeks (baseline) and 6 and 12 months after surgery. Assessors and patients were blinded to treatment condition. Patients were randomized at baseline using a stratified design based on age and type of surgery. Six treatment sessions were delivered by a physical therapist over the telephone. The CBPT intervention focused on walking and functional goal setting, relaxation techniques, symptom management through problem solving, and replacing negative thoughts about activity with positive ones. Separate multivariable regression analyses were conducted on the total sample and on those who completed all 6 sessions (n=179). Intent-to-treat models adjusted for the outcome at baseline, age, study site, depressive symptoms, and type of surgical procedure. Missing data were handled with multiple imputation. The level of significance was set at α=0.05.
Results: Follow-up rate at 12 months was 93% and 88% for patient-reported outcomes and physical activity, respectively. While CBPT participants had an improvement in disability at 12 months compared to Education that approached significance (3.14-points [95% CI, -6.75 to -0.47]), statistically significant group differences in patient-reported and physical activity outcomes were not found at 6 and 12 months after surgery. For individuals who completed all six treatment sessions, CBPT participants had disability scores that were significantly lower (4.27-points [95% CI, -8.5 to -0.03]) and general physical health scores that were significantly higher (3.22-points [95% CI, 0.16 to 6.28]) than Education participants at 12 months. CBPT participants were 69% less likely to have a re-hospitalization compared to Education participants between 6 weeks and 12 months after surgery (p=.02).
Conclusion(s): No differences were found in patient-reported and physical activity outcomes between the CBPT and Education telephone counseling interventions for patients after back surgery. However, a physical therapist-delivered cognitive-behavioral intervention improved disability and physical health in treatment completers and had an impact on re-hospitalization.
Implications: Future work is needed to better understand the effects of different types of telephone counseling relative to usual care and the benefits of CBPT when implemented in patients who are at high-risk for poor outcomes.
Keywords: spine surgery, psychosocial, randomized trial
Funding acknowledgements: Research reported in this abstract was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (CER-1306-01970).
Purpose: The purpose was to compare which of two treatments delivered by telephone - a CBT-based physical therapy program (CBPT) or an Education program - are more effective for improving patient-centered outcomes after lumbar spine surgery.
Methods: A multicenter randomized controlled trial was conducted at 2 medical centers (NCT02184143). 248 patients undergoing surgery for a lumbar degenerative condition (spinal stenosis, spondylosis with or without myelopathy, and degenerative spondylolisthesis) using laminectomy with or without arthrodesis were randomized into CBPT (n=124) or an attention-matched Education group (n=124). The primary patient-reported outcomes were disability (Oswestry Disability Index: ODI), pain intensity (Brief Pain Inventory), and physical and mental health (SF-12). A secondary outcome was observed physical activity which was assessed using accelerometers. Health care utilization was also recorded. Patient assessments occurred preoperatively and at 6 weeks (baseline) and 6 and 12 months after surgery. Assessors and patients were blinded to treatment condition. Patients were randomized at baseline using a stratified design based on age and type of surgery. Six treatment sessions were delivered by a physical therapist over the telephone. The CBPT intervention focused on walking and functional goal setting, relaxation techniques, symptom management through problem solving, and replacing negative thoughts about activity with positive ones. Separate multivariable regression analyses were conducted on the total sample and on those who completed all 6 sessions (n=179). Intent-to-treat models adjusted for the outcome at baseline, age, study site, depressive symptoms, and type of surgical procedure. Missing data were handled with multiple imputation. The level of significance was set at α=0.05.
Results: Follow-up rate at 12 months was 93% and 88% for patient-reported outcomes and physical activity, respectively. While CBPT participants had an improvement in disability at 12 months compared to Education that approached significance (3.14-points [95% CI, -6.75 to -0.47]), statistically significant group differences in patient-reported and physical activity outcomes were not found at 6 and 12 months after surgery. For individuals who completed all six treatment sessions, CBPT participants had disability scores that were significantly lower (4.27-points [95% CI, -8.5 to -0.03]) and general physical health scores that were significantly higher (3.22-points [95% CI, 0.16 to 6.28]) than Education participants at 12 months. CBPT participants were 69% less likely to have a re-hospitalization compared to Education participants between 6 weeks and 12 months after surgery (p=.02).
Conclusion(s): No differences were found in patient-reported and physical activity outcomes between the CBPT and Education telephone counseling interventions for patients after back surgery. However, a physical therapist-delivered cognitive-behavioral intervention improved disability and physical health in treatment completers and had an impact on re-hospitalization.
Implications: Future work is needed to better understand the effects of different types of telephone counseling relative to usual care and the benefits of CBPT when implemented in patients who are at high-risk for poor outcomes.
Keywords: spine surgery, psychosocial, randomized trial
Funding acknowledgements: Research reported in this abstract was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (CER-1306-01970).
Topic: Pain & pain management; Orthopaedics; Musculoskeletal: spine
Ethics approval required: Yes
Institution: Vanderbilt University Medical Center
Ethics committee: Health Sciences Committee of the Institutional Review Board
Ethics number: 140057
All authors, affiliations and abstracts have been published as submitted.
