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.
| Discipline Area | Score |
|---|---|
| Physician |  |
| Rehab Clinician (OT/PT) |  |
Physician rater
Unexpected negative findings that telephone-delivered CB physical therapy for lower limb injuries doesn't provide significant benefit over usual care/education. The reasons are not clear, but may direct us to choose the less expensive care modalities given no additional benefit with more costly or time-consuming interventions.
, McMaster University