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.

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). Design: Randomized controlled trial. Setting: Community-dwelling women in Stockholm. Participants: A total of 113 women aged 60-93 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. Conclusion: 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.

Association between self-rated health and the risk of hip fracture and mortality in a cohort of older women during a 10-year follow-up.

Fragility fracture of the hip is associated with reduced functional status and mortality. Poor self-rated health (SRH) might be such an indicator. Our aim was to study if SRH was associated with hip fractures and all-cause mortality within the next 10 years in community-dwelling older women. A population-based sample of 350 women aged between 69 and 79 years (median 72.4) assessed their SRH by answering the question "How would you rate your health right now" by putting a mark on a visual-analogue scale (0-100 mm). Information on hip fracture and mortality over the next 10 years was retrieved from health care registers. The association between SRH and hip fracture and all-cause mortality was tested with a Cox proportional hazards regression model. SRH was divided into low, intermediate, and high (reference) assessed SRH. During the study, 40 hip fractures and 72 deaths occurred. The median value of SRH was 62 mm (IQR 50-81 mm). The age-adjusted hazard ratio (HR) for hip fracture was significantly higher in the group with low and intermediate SRH; HR: 3.17 (95% CI 1.25-8.01), and HR: 2.75 (95% CI 1.08-7.04), compared with high SRH. Adding bone mineral density (at the femoral neck) gave even greater risk. We did not find the hypothesized association between SRH and mortality. In our study, SRH indicated a higher risk of future hip fracture in older women. SRH might be a marker that could add information about the risk of hip fracture independently of bone mineral density.

Wearing an Activating Spinal Orthosis and Physical Training in Women With Osteoporosis and Back Pain: A Postintervention Follow-Up Study.

OBJECTIVE: To assess the duration of benefits on back pain and back extensor strength in women with osteoporosis who had previously participated in a randomized controlled trial (RCT) involving either exercise or wearing a spinal orthosis. DESIGN: A 6-month postintervention follow-up of women who were involved in the interventions in the RCT. SETTING: The study was conducted in a primary health care center in Stockholm, Sweden. PARTICIPANTS: In this follow-up study 31 women participated in the spinal orthosis group, and 31 women participated in the exercise group, with a median age of 76 years in both groups (N=62). All women were diagnosed as having osteoporosis, had back pain with or without vertebral fracture, and were 60 years or older, which were the inclusion criteria in the RCT. INTERVENTIONS: The participants received no controlled supervision. The spinal orthosis group was asked to wear the orthosis, and the training group was asked to follow an exercise program for another 6 months voluntarily. MAIN OUTCOME MEASURES: Back extensor strength was measured with a computerized device; back pain was estimated by the visual analog scale and by Borg CR-10. RESULTS: After 6 months there were no significant differences between the groups in back extensor strength or back pain. Analyses within the groups showed that achieved results during 6 months intervention in the RCT were maintained after 6 months of voluntary use of the spinal orthosis and training. In the spinal orthosis group, back extensor strength mean was 81.7 N, and back pain median was 3 mm. In the training group back extensor strength mean was 72.8 N, and back pain median was 3 mm. There were no changes for any other measurements performed. CONCLUSIONS: Voluntary use of the spinal orthosis or exercise during a 6-month follow-up period maintained the increase in back extensor muscle strength obtained during the RCT. Estimation of back pain was not influenced. This indicates that the women had continued to use the spinal orthosis and exercise.

Effect of treatment on back pain and back extensor strength with a spinal orthosis in older women with osteoporosis: a randomized controlled trial.

The treatment effect of an activating spinal orthosis on back pain and back extensor strength was compared to a training group and to a control group. Between the groups, there was no significant difference in back pain, back extensor strength, or kyphosis index after the 6 months of treatment. PURPOSE: The aim of this study was to study the effect of treatment with an activating spinal orthosis on back pain, back extensor strength, and kyphotic index. Our hypothesis was that an activating spinal orthosis may be an alternative treatment to decrease back pain and increase back extensor strength. METHODS: A total of 113 women aged ≥ 60 years with back pain and osteoporosis, with or without vertebral fractures, were randomized to three groups: a spinal orthosis group, an equipment training group, and a control group. All three groups were examined at baseline and followed up after 3 and 6 months. Statistical analyses were performed with a mixed model for repeated measures according to intention to treat (ITT) and per protocol (PP). RESULTS: A total of 96 women completed the study. Between the groups, there was no significant difference in baseline characteristics. Comparison between groups showed no significant difference in back pain, back extensor strength, or kyphosis index at the follow-up after 6 months according to ITT and PP analyses. Analysis in each group showed that the back extensor strength had increased by 26.9% in the spinal orthosis group, by 22.1% in the exercise training group and by 9.9% in the control group. CONCLUSIONS: Six months' treatment by an activating spinal orthosis showed no significant difference in back pain, back extensor strength, or kyphosis index between the three groups. In the spinal orthosis group, present back pain decreased slightly and back extensor strength increased by 26.9% which indicates that the spinal orthosis may become an alternative training method. Clinicaltrials.com ID: NCT03263585.