Validation of a Clinical Prediction Rule to Identify Patients Likely to Benefit from Spinal Manipulation: A Randomized Clinical Trial

摘要

The primary aim of this multicenter, randomized clinical trial was to validate a clinical prediction rule (CPR) to identify patients with low back pain (LBP) likely to benefit from spinal manipulation. Subjects were 131 consecutive patients referred for physical therapy. Patients with positive neurologic signs or other red flags for spinal manipulation were excluded. After completing a standardized history and physical examination, patients were randomly assigned to receive spinal manipulation (n=7O) or a stabilization exercise intervention (n=61). Patients were seen in physical therapy twice the first week, then once a week for the next three weeks, for a total of five sessions. A single manipulative intervention was used for patients who received spinal manipulation during each of the first two sessions, who then completed the stabilization exercise intervention for the remaining three weeks. Patients who achieved at least a 50% improvement in their Oswestry Disability Questionnaire (ODQ) score were classified as a success. Patients who met at least 4 out of 5 criteria on the CPR were classified as positive. A repeated measures multivariate analysis of variance (MANOVA) was performed, followed by a Bonferroni procedure for planned comparisons. Sensitivity, specificity, and positive and negative likelihood ratios with associated 95% confidence intervals were calculated. Results showed a significant three-way CPR/Intervention/Time interaction for the overall repeated measures MANOVA (p<.001). Patients classified as positive on the CPR who received spinal manipulation achieved 2.5 times the minimum clinically important difference (MCID) on the ODQ compared with similarly treated patients classified as negative on the CPR. These patients also had 3.4 times the MCID of patients classified as positive on the CPR who received the exercise intervention (p<.001). The results support the validity of the spinal manipulation CPR. (42 tables, 16 figures, 330 refs.).