The Effect of Group Training or Spinal Orthosis on Quality of Life and Potential Plasma Markers of Pain in Older Women With Osteoporosis. A Randomized Controlled Trial.
Elin Uzunel, Ann-Charlotte Grahn Kronhed, Christina Kaijser Alin and 3 others
PMID 38163036WHAT IT FOUND
Neither group exercise with home exercises nor an activating spinal orthosis produced no clear quality-of-life benefit over 6 months in 113 older women with osteoporosis and back pain.
Mobility scores were worse in the orthosis group than controls.
Key findings
01SF-36 quality-of-life scores did not differ significantly between groups in mean change from baseline to 6 months.
02In QUALEFFO-41, a significant difference was found only for mobility when comparing the spinal orthosis group with controls; mobility changed 6.2 points worse than controls on a scale where higher means worse.
03IL-6 plasma levels were lower at 6 months in the spinal orthosis group, and this change was significant compared with controls and exercise.
STILL TO COME
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What it does not show
The investigators were not blinded because the research group was too small. The authors state that power calculations were not performed for the quality-of-life and pain-marker endpoints, so the study may have been underpowered for these analyses. Recruitment was partly from an osteoporosis school, and controls may have continued osteoporosis-targeted home exercises during the study. Osteoporosis was self-reported, and the group included women with and without vertebral fractures, which may have made the population heterogeneous. Many plasma pain-marker values were missing and standard deviations were large. Groups differed at baseline in pain medication, fall risk, previous stroke, and some quality-of-life domains. Home exercise adherence was not recorded.
Declared interests
No funding source or conflict-of-interest declaration is given in the supplied text. Medi AB provided the Spinomed orthosis.
The easy way to misread this
Do not conclude that exercise or the orthosis improves quality of life. The primary quality-of-life outcome showed no clear benefit, and the only significant quality-of-life difference was worse mobility in the orthosis group. The lower IL-6 level in the orthosis group is a secondary plasma finding, not proof of reduced pain or better function.