Traditional Chinese medicine pattern scale as an outcome measure for chronic low back pain: Lessons from a three-arm randomized controlled trial

To explore the use of a traditional Chinese medicine (TCM) pattern scale as an outcome measure to evaluate the management of patients with chronic low back pain (CLBP). A total of 204 participants were recruited and randomly allocated into three CLBP treatment groups: Tuina only, physiotherapy only, and a combined physiotherapy + Tuina group. All participants were assessed for treatment outcomes using the TCM pattern scale as a substudy to a randomized controlled trial in which the Visual Analog Scale (VAS) was the primary outcome measure. TCM pattern scores were recorded by non-TCM research assistants who were trained to administer a TCM pattern questionnaire developed by the authors in collaboration with TCM experts. Most participants (83%) were classified as having kidney deficiency pattern as the primary TCM pattern at baseline. All three intervention groups showed a significant decrease in overall TCM pattern score at month 2 (M2) and month 5 (M5). However, when the nimodipine method was applied, none of the three treatment arms showed a statistically significant change in the effective rate, even though the parent study reported a significant decrease in VAS scores in all treatment arms. This study found improvements in both the dominant TCM pattern score and the overall TCM pattern score for each group. These findings suggest that TCM pattern diagnosis, including entities recognized in International Classification of Diseases, 11th Revision (ICD)-11, may be used as a quantitative outcome measure to reflect response to TCM-based intervention. The TCM pattern scale reported here may potentially be applied in other chronic pain studies involving TCM patterns. Further studies are warranted to validate this scale in other clinical conditions.