A randomized controlled trial of combined manipulative therapy, stabilizing exercises, and specialist consultation compared to specialist consultation alone for chronic low back pain

The aim of this study was to assess the effectiveness, as well as cost-effectiveness, of combined manipulative therapy, stabilizing exercises, specialist consultation, and patient education (combination treatment) compared with that from specialist consultation and patient education alone (consultation) for chronic low back pain (CLBP). Secondary objectives were to examine the predictive factors for one-year unfavorable outcome of CLBP and psychosocial differences as determinants for recovery from CLBP following the combination treatment or specialist consultation alone. Additionally, the aim was to assess the changes in physical activity between groups at one year and changes in functional variables between the groups at five months. Of 204 CLBP patients, 102 were randomized to a combination group and 102 to a consultation-alone group. All patients were clinically examined, informed about back pain, and encouraged to stay active and exercise according to specific instructions based on clinical evaluation. Treatment in the combination group included four sessions both of manipulative therapy and of stabilizing exercises aimed at correcting motor control of the trunk. Subjective pain, disability, health-related quality of life, physical activity, coping strategies, satisfaction with care, days of sick leave, consumption of health services, and costs were assessed by several questionnaires. For predictive analysis of treatment outcome, sociodemographic characteristics, work ability, and psychological variables were evaluated and functional assessments performed. Significant improvement occurred in both groups on every self-rated outcome measurement. Within two years, the combination group showed only slightly more significant reduction on the Visual analogue scale (VAS) and clearly greater patient satisfaction than in the consultation group. Specialist consultation alone was more cost-effective in view of both health care use and work absenteeism, and led to an increase in health-related quality of life equal to that from the combination treatment. Patients in the consultation group also tended to increase their intensity of physical exercise, other activities, and their active time more than did those in the combination group. Psychometric factors, longer previous sick-leave days, and a low to moderate level of pain intensity proved strongly to predict unfavorable treatment outcome. The Multidimensional Pain Inventory (MPI) was used to identify three patient subgroups to determine treatment outcome. These subgroups were active copers (AC), interpersonally distressed (ID), and dysfunctional (DYS) patients. They were distinguished by level of pain severity, affective distress, life control, and of activity.