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J Am Osteopath Assoc · Oct 2013
Randomized Controlled TrialPrevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria.
- John C Licciardone and Subhash Aryal.
- The Osteopathic Research Center, University of North Texas Health Science Center Texas College of Osteopathic Medicine, 3500 Camp Bowie Blvd, Fort Worth, TX 76107-2644. john.licciardone@unthsc.edu.
- J Am Osteopath Assoc. 2013 Oct 1; 113 (10): 728-36.
ContextBack pain during pregnancy may be associated with deficits in physical functioning and disability. Research indicates that osteopathic manual treatment (OMT) slows the deterioration of back-specific functioning during pregnancy.ObjectiveTo measure the treatment effects of OMT in preventing progressive back-specific dysfunction during the third trimester of pregnancy using criteria established by the Cochrane Back Review Group.DesignA randomized sham-controlled trial including 3 parallel treatment arms: usual obstetric care and OMT (UOBC+OMT), usual obstetric care and sham ultrasound therapy (UOBC+SUT), and usual obstetric care (UOBC).SettingThe Osteopathic Research Center within the University of North Texas Health Science Center in Fort Worth.ParticipantsA total of 144 patients were randomly assigned and included in intention-to-treat analyses.Main Outcome MeasuresProgressive back-specific dysfunction was defined as a 2-point or greater increase in the Roland-Morris Disability Questionnaire (RMDQ) score during the third trimester of pregnancy. Risk ratios (RRs) and 95% confidence intervals (CIs) were used to compare progressive back-specific dysfunction in patients assigned to UOBC+OMT relative to patients assigned to UOBC+SUT or UOBC. Numbers needed to treat (NNTs) and 95% CIs were also used to assess UOBC+OMT vs each comparator. Subgroup analyses were performed using median splits of baseline scores on a numerical rating scale for back pain and the RMDQ.ResultsOverall, 68 patients (47%) experienced progressive back-specific dysfunction during the third trimester of pregnancy. Patients who received UOBC+OMT were significantly less likely to experience progressive back-specific dysfunction (RR, 0.6; 95% CI, 0.3-1.0; P=.046 vs UOBC+SUT; and RR, 0.4; 95% CI, 0.2-0.7; P<.0001 vs UOBC). The effect sizes for UOBC+OMT vs UOBC+SUT and for UOBC+OMT vs UOBC were classified as medium and large, respectively. The corresponding NNTs for UOBC+OMT were 5.1 (95% CI, 2.7-282.2) vs UOBC+SUT; and 2.5 (95% CI, 1.8-4.9) vs UOBC. There was no statistically significant interaction between subgroups in response to OMT.ConclusionOsteopathic manual treatment has medium to large treatment effects in preventing progressive back-specific dysfunction during the third trimester of pregnancy. The findings are potentially important with respect to direct health care expenditures and indirect costs of work disability during pregnancy.
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