Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions.Background
Objectives
The clinical assessment of Chronic Low Back Pain (CLBP) is usually undertaken at a single time point at clinic rather than through continuous monitoring. To address this, a wearable prototype sensor to monitor motion of the lumbar spine and pelvis has been developed. The system devised was based on inertial sensor technology combined with wireless Body Sensor Network (BSN) platform. This was tested on 16 healthy volunteers for ten common movements (including sit to stand, lifting, walking, and stairs) with results validated by optical tracking. Preliminary findings suggest good agreement between the optical tracker and device with mean average orientation error (°) ranging from 0.1 ± 2.3 to 4.2 ± 2.6. The sensor repeatability errors range from 0 to 4° while subject movement variability ranged from 4% to 14%. Parameters of angular motion suggest greater movement of the lumbar spine compared to the pelvis with mean velocities (°/s) for lumbar spine ranging from 15.3 to 74.13 and pelvis ranging from 5.6 to 40.74. Further analysis revealed the extent to which the pelvis was engaged, as a proportion of the total movement. This demonstrated that the pelvis underwent smooth transitions from low (0.02), moderate (0.4) to high (0.99) use during different movement phases.Background
Sensor Development, Testing and Results
Preoperative punction CT-guided was performed in 51.7% of patients. It was positive in 26.7% of those patients. Blood cultures were positive in 29.4% and intra-operative culture was positive in 53% of the pyogenic spondylodiscitis. Staphylococcus aureus was the most common organism. The averaged onset of symptoms-surgery period was 6.75 months in tuberculous spondylodiscitis and 3.2 months in pyogenic spondylodiscitis. Double-level spondylodiscitis was observed in 41.4%. The spinal region most frequently affected by spondylodiscitis was the thoracolumbar and lumbar spine in 66% of cases. All of the patients with incomplete neurologic impairment showed improvement after surgery. There were no recurrences of infection. There was a statistically significant difference (p=0.011) in the loss of correction of saggital angle: more loss of correction in Group II 7.07° (range, 0°–17°) than in Group I 1.8° (range, 0°–5°). The saggital angle preoperative/postoperative/3 months postop/6 months postop/12 months postop/ Final was: 14.42° /1.96° /2.75° /2.83° /2.92° /3.75° (means) in Group I. −7.57°/–8.43°/ −3.21°/ −1.71°/ −1.93°/ −1.36° in Group II (in this group, there was a significant loss of correction between inmediate postoperative-3 months postop and 3 months postop-6 months postop). There were statistically significant differences in operative time and in blood loss (more in Group I). The preoperative Visual Analogic Scale score averaged 9 in Group I and 9 in Group II and improved to 2.4 and 2.33 after surgery, respectively.
