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Randomized Controlled Trial Comparative Study Clinical Trial
Influence of estrogen-progestin treatment on back pain and disability among slim premenopausal women with low lumbar spine bone mineral density. A 2-year placebo-controlled randomized trial.
- E S Kyllönen, H K Väänänen, J H Vanharanta, and J E Heikkinen.
- Department of Physical Medicine and Rehabilitation, Oulu University, Finland. eero.kyllonen@oulu.fi
- Spine. 1999 Apr 1; 24 (7): 704-8.
Study DesignA 2-year randomized controlled trial.ObjectivesTo examine the possible preventive or aggravating effect of estrogen-progestin treatment on the back symptoms of slim premenopausal women with low lumbar spine bone mineral density.Summary Of Background DataThe incidence of back pain, sciatica, or both starts to increase clearly among 45-54-year-old Finnish women.MethodsForty-eight 39- to 49-year-old premenopausal women with a body mass index of 21 or less and a lumbar spine bone mineral density (L2-L4) of 1.1 +/- 1 g/cm3 or less compared with the normative population were recruited into the study. The women were assigned randomly to receive either estradiol-noretisteron acetate treatment or placebo. Back pain, symptoms, and disability were assessed with the Million and Oswestry questionnaires and pain drawings during the follow-up period at 0, 12, and 24 months. Inquiry also was made concerning previous back pain and sciatica history.ResultsThere was a statistically significant decrease in nighttime back pain (P < 0.001) and the total Oswestry disability scores (P < 0.004) in the hormone-treated group compared with the control group during the follow-up, but no statistically significant differences were found in daytime back pain. At baseline, the cumulative incidence in a history of pain radiating from the buttock to the foot in this osteopenic study group was 31/48, (64.5%; 95% CI 50.5-78.6), which is much more than the predicted 20/48, (42.4%; 95% CI 39.0-45.7) at this age according to a previous population study. The cumulative incidence of at least one back pain episode 44/48, (91.7%; 95% CI 83.6-99.8) was somewhat higher in these participants than was predicted for a comparative population of women this age, 38/48 (79.2%; 95% CI 70.2-87.3).ConclusionsIt seems that this regimen may have alleviating effects on nighttime back pain and functional back disability in slim osteopenic premenopausal women.
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