1. P REGNANCY -R ELATED L OW B ACK P AIN AND THE EFFICACY OF CAM I NTERVENTION : A PILOT RANDOMIZED CONTROLLED TRIAL Caroline Peterson, DC, PhD, MPH, CPM Mitch Haas, DC, MA W. Thomas Gregory, MD

2. P REGNANCY -R ELATED L OW B ACK PAIN E PIDEMIOLOGY Insidious onset during pregnancy > 50% all pregnancies 1,2 Intensity and frequency increases 3 Only consistent predictor: Hx LBP 68% LBP unreported 1 25% of those reporting LBP are treated 1 2/3 require sick leave due to LBP 4 1/3 untreated LBP continues 1 year postpartum 1,5,6 at increased risk of comorbidities 7

3. P ILOT R ANDOMIZED C ONTROLLED T RIAL Participants Healthy 20-49 years old Pregnant with singleton LBP of insidious onset during pregnancy Comparison groups Exercise Spinal manipulation Neuro-emotional technique Enter study at any point in pregnancy Study visits parallel prenatal visits

4. S AMPLE C HARACTERISTICS ( N =57) M EAN OR F REQUENCY 29.7 years old (5.0 SD), range 20-40 77% White non-Hispanic 66% at least 4 year college degree 72% married 77% work outside home during pregnancy 3 times pregnant (1.9 SD), range 1-9 1 times given birth (1.1 SD), 0-5 25.4 wks entered study (6.4 SD), range 10-37

5. S AMPLE H ISTORY OF L OW B ACK P AIN M EAN OR F REQUENCY 54% history of low back pain prior to pregnancy 25.4 weeks gestation LBP began, range 2-28 12.3% taking medication for LBP at study start 25% took time off work due to LBP 27.9 BMI at study entry, range 21-35 93% health very or quite good prior to pregnancy 61% at least weekly exercise prior to pregnancy Location LBP: Lumbosacral (50.9%), Pelvis (21%), Lumbar (14%), Composite (10.5%)

6. S PECIFIC A IM #1 Determine the Feasibility of the Study Can 90 pregnant women be recruited within 12 months? Can participants comply with exercise expectation and treatment schedule? Can a completion rate of 90% be achieved? What is the average cost per participant? Does a qualitative component to the study further explain PRLBP?

7. C AN 90 PREGNANT WOMEN BE RECRUITED WITHIN 12 MONTHS ? Assessed for eligibility n=138 Excluded n=81 Randomized n=57 Discontinued prior to 37 weeks n=12 Exercise n=7 (32%) NET n=2 (10%) SMT n=3 (20%) Sample analyzed n=57 Exercise n=22 (n=16, 2+ data points) NET n=20 (n=19, 2+ datapoints) SMT n=15 (n=15, 2+ datapoints)

8. Can a completion rate of 90% be achieved? No: 80% achieved Stated Reasons for Attrition Swine Flu n=2 No improvement after 1 visit n=1 Wants physical therapy n=1 Lost faith in modality n=1 Politics n=1 Too busy n=1 MVA n=1 Too far n=1 Friend died n=1 No show/no response n=1

9. Can participants comply with exercise expectation and treatment schedule? Exercise Consistent & >50% Improvement n=7 Inconsistent & >50% Improvement n=5 Consistent & <50% Improvement n=2 Inconsistent & <50% Improvement n=2 Treatment schedule To some degree

10. What is the average cost per participant? Total cost $233/person Study visit cost $160/person Number of Study Visits 7.4 (3.14SD) Range 2-19 $20 per visit + $20 interview Recruitment costs $50/person Magazine ad $32/person Fliers, brochures, postage $18/person Lab costs $23/person

11. S PECIFIC A IM #2 Are the study questions appropriate? 1. Does intervention alter pain intensity or disability? 2. Does pain intensity or disability influence intra- uterine attachment? 3. Does pain intensity or disability influence heart rate variability? 4. Does pain intensity or disability influence labor & delivery complications? Disability = Roland Morris Disability Index Intensity = 11 point VAS Intra-uterine attachment = Prenatal Attachment Inventory

12. R OLAND M ORRIS D ESCRIPTIVE S TATS Group (SD) Start (SD) End % Improve % Improve 50% Exercise10.7 (4.9)6.1 (5.9)3855 NET9.3 (3.7)5.7 (4.7)2350 SMT8.7 (4.1)4.1 (4.3)5567

13. VAS P AIN I NTENSITY D ESCRIPTIVE S TATS Group (SD) Start (SD) End % Improve % Improve 50% Exercise3.9 (1.5)2.4 (1.8)2655 NET3.2 (1.4)2.4 (1.6)1035 SMT3.5 (1.1)1.9 (1.7)4453

14. L INEAR R EGRESSION M ODEL TermsRM Adjusted* Mean Difference (95% CI) VAS Adjusted* Mean Difference (95% CI) Ex vs. NET0.7 (-2.9, 4.2)0.1 (-1.0, 1.3) Ex vs. SMT0.01 (-3.2, 3.2)-0.3 (-1.5, 1.0) SMT vs. NET1.2 (-2.1, 4.5)0.5 (-0.8, 1.7) *Adjusted for gestational age at entrance into the study, outcome measure score at baseline, maternal age, and history of low back pain

15. L ABOR & D ELIVERY O UTCOMES Tx GrpRipen n (%) Induct n (%) Augmt n (%) Pain Med n (%) Mec n (%) Nuchal Cord n (%) Ex (n=13) 2 (15)4 (30)7 (54) 4 (30) NET (n=11) 004 (36)3 (27)02 (18) SMT (n=10) 2 (20)4 (40)6 (60)3 (30)1 (10)2 (20)

16. A NALYSIS N EXT S TEPS Heart Rate Variability Oxytocin Attachment Prenatal Attachment Inventory Adult Attachment Interview Postpartum Mommy/Baby Video

17. T HANKS TO O UR F UNDERS ! NCCAM/NIH 2T32AT0026888-06 The ONE Foundation The Tartar Foundation

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