Secondary Outcomes by Main Effects Group
| Outcome | OMT vs Sham OMT | UST vs Sham UST | ||||
|---|---|---|---|---|---|---|
| OMT (n = 230) | Sham OMT (n = 225) | P Value | UST (n = 233) | Sham UST (n = 222) | P Value | |
| RMDQ score, median (IQR)a | ||||||
| Week 4 | 4 (2-8) | 5 (2-9) | .32 | 4 (2-9) | 5 (2-8) | .99 |
| Week 8 | 3 (1-7) | 3 (2-8) | .14 | 3 (1-8) | 4 (1-7) | .76 |
| Week 12 | 2 (1-6) | 3 (1-7) | .07 | 3 (1-7) | 3 (1-7) | .93 |
| SF-36 GH score, median (IQR)b | ||||||
| Week 4 | 71 (55-82) | 72 (52-86) | .39 | 72 (54-87) | 72 (52-82) | .73 |
| Week 8 | 72 (57-85) | 72 (52-85) | .61 | 72 (54-85) | 72 (57-85) | .53 |
| Week 12 | 72 (52-87) | 72 (57-87) | .87 | 72 (52-87) | 74 (54-87) | .66 |
| Lost 1 or more work days in past 4 weeks because of LBP, % (95% CI)c | ||||||
| Week 4 | 10 (4-16) | 14 (7-21) | .41 | 16 (9-23) | 7 (2-12) | .04 |
| Week 8 | 6 (2-11) | 19 (12-27) | .005 | 17 (10-24) | 8 (3-14) | .054 |
| Week 12 | 11 (5-17) | 8 (3-13) | .41 | 13 (6-19) | 6 (1-11) | .11 |
| Very satisfied with back care, % (95% CI)d | ||||||
| Week 4 | 52 (46-59) | 34 (28-41) | <.001 | 41 (35-48) | 45 (38-52) | .44 |
| Week 8 | 61 (54-67) | 39 (33-46) | <.001 | 49 (43-56) | 51 (44-58) | .77 |
| Week 12 | 66 (60-73) | 43 (36-50) | <.001 | 55 (48-61) | 55 (48-62) | .99 |
| LBP co-treatment during study, % (95% CI)e | ||||||
| Exercise programs | 19 (14-24) | 20 (14-25) | .82 | 20 (15-25) | 18 (13-24) | .73 |
| Lumbar supports | 1 (0-3) | 1 (0-2) | >.99 | 1 (0-2) | 1 (0-3) | .68 |
| Nonprescription drugs | 46 (39-52) | 45 (39-52) | .95 | 46 (40-53) | 45 (38-51) | .71 |
| Prescription drugs | 13 (9-18) | 20 (15-26) | .048 | 16 (11-21) | 18 (13-23) | .54 |
| CAM therapies | 15 (11-20) | 17 (12-22) | .63 | 16 (12-21) | 16 (11-21) | .87 |
| Physical therapy | 11 (7-15) | 8 (4-11) | .17 | 9 (5-13) | 10 (6-14) | .74 |
| Hospitalization | 0 (0-0) | 0 (0-1) | .49 | 0 (0-1) | 0 (0-0) | >.99 |
| Surgery | 0 (0-1) | 0 (0-0) | >.99 | 0 (0-0) | 0 (0-1) | .49 |
CAM = complementary and alternative medicine; IQR = interquartile range; LBP = low back pain; OMT = osteopathic manual treatment; RMDQ = Roland-Morris Disability Questionnaire; SF-36 GH = Medical Outcomes Study Short Form-36 Health Survey general health scale; UST = ultrasound therapy.
↵a Higher scores on the RMDQ represent greater disability. P values at each endpoint based on the Mann-Whitney test; N = 455 for all endpoints.
↵b Higher scores on the SF-36 GH represent better health. P values at each endpoint based on the Mann-Whitney test; N = 455 for all endpoints.
↵c Work disability analyses limited to the 215 patients employed full-time at baseline; n = 207, 211, and 211 at the successive endpoints.
↵d n = 416, 426, and 429 at the successive endpoints.
↵e N = 455 for all chronic LBP co-treatments.