OBJECTIVE: Primary purpose was to examine the effects of exercise and use of a spinal orthosis on quality of life (QoL). Secondary, to explore the effects of above-mentioned interventions on plasma levels of potential markers of pain: substance P (SP), calcitonin gene-related peptide (CGRP), and interleukin-6 (IL-6). DESIGNS: Randomized controlled trial. SETTINGS: Community-dwelling women in Stockholm. PARTICIPANTS: a total of 113 women aged 60 to 93 years suffering from back pain and self-reported osteoporosis (n = 113). InterventionS: The randomized controlled trial was 3 armed: participation in an equipment exercise group, treatment with an activating spinal orthosis or controls. The intervention time was 6 months. MAIN OUTCOME MEASURES: QoL (QUALEFFO-41 and SF-36), plasma levels of SP, CGRP, and IL-6 measured at baseline and after 6 months in all 3 arms. RESULTS: No improvement of QoL was found. Comparing change in mobility (QUALEFFO-41), the effect in least squares means was lower in the spinal orthosis group compared with controls. In the exercise group, the role emotional score (SF-36) deteriorated during the intervention. Effect size varied between 0.02 and 0.6. There was no change in the levels of CGRP or SP, while IL-6 levels were lower at 6 months in the spinal orthosis group compared with the other groups. At least 1 previous vertebral fracture was verified by X-ray in 46 women. CONCLUSIONS: The interventions showed none or negative effect on QoL, which was unexpected. The modest effect size may prompt a cautious interpretation. We found a lowering of IL-6 levels in the spinal orthosis group, but more studies are needed.

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