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Prevention of progressive back-specific dysfunction during pregnancy: an assessment of osteopathic manual treatment based on Cochrane Back Review Group criteria
Licciardone JC, Aryal S
The Journal of the American Osteopathic Association 2013 Oct;113(10):728-736
clinical trial
7/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

CONTEXT: Back 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. OBJECTIVE: To 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. DESIGN: A 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). SETTING: The Osteopathic Research Center within the University of North Texas Health Science Center in Fort Worth. PARTICIPANTS: A total of 144 patients were randomly assigned and included in intention-to-treat analyses. MAIN OUTCOME MEASURES: Progressive 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 versus each comparator. Subgroup analyses were performed using median splits of baseline scores on a numerical rating scale for back pain and the RMDQ. RESULTS: Overall, 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 to 1.0; p = 0.046 versus UOBC+SUT; and RR 0.4; 95% CI 0.2 to 0.7; p < 0.0001 versus UOBC). The effect sizes for UOBC+OMT versus UOBC+SUT and for UOBC+OMT versus UOBC were classified as medium and large, respectively. The corresponding NNTs for UOBC+OMT were 5.1 (95% CI 2.7 to 282.2) versus UOBC+SUT; and 2.5 (95% CI 1.8 to 4.9) versus UOBC. There was no statistically significant interaction between subgroups in response to OMT. CONCLUSION: Osteopathic 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.
Reprinted from JAOA, The Journal of the American Osteopathic Association. Copyright American Osteopathic Association. Permission given with the consent of the American Osteopathic Association.

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