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Cognitive-behavioral-based physical therapy for improving recovery after a traumatic lower-extremity injury: the results of a randomized controlled trial
Archer KR
Journal of Bone and Joint Surgery -- American Volume 2024 Jul 17;106(4):1300-1308
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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.

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