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1 Supplementary Online Content Fritz JM, Magel JS, McFadden M, et al. Early physical therapy vs usual care in patients with recent onset low back pain: a randomized clinical trial. JAMA. doi: /jama eappendix 1. Early Physical Therapy Protocol eappendix 2. Per Protocol Secondary Analyses etable 1. Participant Characteristics Per-Protocol Secondary Analysis etable 2. Early Physical Therapy vs Usual Care: Primary and Secondary Outcomes Per-Protocol Analysis etable. Early Physical Therapy vs Usual Care Differences in Dichotomous Secondary Outcomes This supplementary material has been provided by the authors to give readers additional information about their work.
2 eappendix 1. Early Physical Therapy Protocol INTERVENTION Advice and Education Spinal Manipulation Spinal Range of Motion Exercise Spinal Strengthening Exercise assessment Session 1 (within 72 hours) Session 2 (2- days later) Session (1 week later) Session 4 (1 week later) X As needed As needed As needed As needed X X X X X X X Intervention Descriptions: Advice and Education: The patient was provided a copy of the Back Book. The contents were reviewed with the patient. Emphasis was placed on the importance of staying active for recovery and patients were advised that spinal imaging was not helpful for determining treatment strategies for individuals with acute, non-specific low back pain. Spinal Manipulation: The preferred manipulation technique was performed with the patient supine. The physical therapist stands opposite the side to be manipulated and side-bends the patient away from the therapist. The patient interlocks his or her fingers behind the head. The physical therapist rotates the patient, and delivers a high-velocity, low-amplitude thrust to the anterior superior iliac spine in a posterior/inferior direction (fig. 1). After the manipulation, the therapist noted if a cavitation (i.e., a pop ) was heard or felt by the therapist or patient. If a cavitation was noted, the physical therapist proceeded to exercise instruction. If no cavitation was noted, the patient was repositioned, and the manipulation attempted again. If no cavitation occurred on the second attempt, the physical therapist manipulated the opposite side. A maximum of 2 attempts per side was permitted. If no cavitation is produced after the fourth attempt, the physical therapist proceeded to exercise instruction. An alternative side-lying technique (fig 2) could be substituted for patient comfort or preference. Figure 1 preferred spinal manipulation technique Figure 2 alternative spinal manipulation technique
3 Spinal Range of Motion Exercises: Patients were instructed to perform supine pelvic tilting or quadruped spinal range of motion (fig. ) -4 times throughout the day. Patients were instructed to move through the greatest range of motion possible. Figure quadruped spinal range of motion exercise. Spinal Strengthening Exercises: The strengthening exercise series was designed to strengthen muscles of the trunk identified as primary stabilizers of the lumbar spine, and with some evidence to support their effectiveness in reducing the risk of recurrence in individuals with LBP. Subjects were instructed in a progression as outlined below and were instructed to perform the exercises daily. Additional more advanced strengthening exercises could be added for more advanced patients.
4 Additional Contributions: We thank the patients for granting permission to publish this information.
5 eappendix 2. Per protocol secondary analyses Subjects were excluded in the per-protocol analyses for the following reasons: Subjects were excluded from the usual care group because they sought physical therapy during the first 4 weeks following enrollment. 1 Subject randomized to early PT who erroneously received usual care was included in the usual care group. 5 Subjects were excluded from the early physical therapy group because they did not complete a compliant physical therapy intervention. A compliant physical therapy intervention required that a patient attend at least sessions and receive spinal manipulation in sessions 1 and 2, and some exercise in sessions and 4 (if applicable). etable 1. Participant Characteristics Per-Protocol Secondary Analysis Usual Care (n = 110) Early Physical Therapy (n = 102) Age (mean (sd) years) 6.5 (10.2) 8.2 (10.4) Female gender (n, %) 52 (47.%) 60 (58.8%) Race/Ethnicity (n, %) White Hispanic African American Other/multi-racial 87 (79.1%) 1 (11.8%) 2 (1.8%) 8 (7.%) 8 (81.4%) 5 (4.9%) (2.9%) 11 (10.8%) Body mass index (mean (sd) kg/m 2 ) 29.0 (8.1) 28.6 (7.2) Married/live with significant other (n, %) 68 (61.0%) 66 (64.7%) Education (n, %) Completed high school Completed post-high school degree Employment status (n, %, employed outside the home) Co-Morbid Health Conditions (n, %) Diabetes Hypertension Anxiety/Depression Upper back /neck pain Current Medications for Back Pain (n, %) Non-steroidal anti-inflammatory Opioids Muscle relaxers Steroid anti-inflammatory 108 (98.2%) 100 (98.0%) 47 (42.7%) 55 (5.9%) 90 (81.8%) 86 (84.%) 5 (4.5%) 9 (8.2%) 1 (28.2%) 8 (4.5%) 72 (65.5%) 0 (27.%) 59 (5.6%) 15 (1.6%) 8 (7.%) 2 (2.0%) 7 (6.9%) 24 (2.5%) 9 (8.2%) 69 (67.6%) 27 (26.5%) 59 (57.8%) 10 (9.8%) (2.9%) Other Current Smoker (n, %) 7 (6.4%) 9 (8.8%) Past History of Treated Low Back Pain (n, 71 (64.5%) 70 (68.6%)
6 %) Oswestry Disability Index Score (mean, sd) 40.6 (12.0) 41.2 (14.1) Numeric Pain Rating (mean, sd) a 5.1 (1.9) 5. (1.8) Fear-Avoidance Beliefs (mean, sd) Physical Activity Subscale Work Subscale 15. (4.9) 12. (10.2) 14.7 (5.1) 11. (9.0) Pain Catastrophizing Scale (mean, sd) b 14.1 (10.2) 1.8 (10.7) EQ-5D Quality of Life (mean, sd) c 0.66 (0.16) 0.66 (0.16) EQ-5D Overall Health Self-Rating (mean, sd) c 66.4 (19.4) 69.0 (16.4) a missing scores (1 early physical therapy, 2 usual care), means reflect multiple imputation for missing scores b 1 missing score (1 usual care), mean reflects multiple imputation for missing score c 1 missing score (1 early physical therapy), mean reflects multiple imputation for missing score
7 etable 2. Early Physical Therapy vs. Usual Care: Primary and Secondary Outcomes Per- Protocol Analysis Outcome: Usual Care Early Intervention Visit PRIMARY OUTCOME: Oswestry Disability Index Score a (0-100 scale with indicating worse function) Score 40.6 (8.4, 42.9) 4 Week 14.4 (12.0, 16.8) 10.1 (8.1, 12.0) (6.7, 11.2) SECONDARY OUTCOMES: Numeric Pain Rating b (0-10 scale with pain intensity) Pain Catastrophizing Scale c (0-52 scale with paincatastrophizing beliefs) FABQ Physical Activity d (0-24 scale with fear-avoidance beliefs related to physical activity) 5.1 (4.7, 5.4) 4 Week 2.2 (1.8, 2.5) 1.8 (1.5, 2.2) (1.2, 1.8) 14.1 (12.2, 16.1) 4 Week 7.6 (6.2, 9.0) 5.2 (4.0, 6.4) (.1, 5.7) 15. (14.4, 16.2) 4 Week 7.9 (6.9, 9.0) Change from (-28.9, ) -0.8 (-2.7, ) -1.8 (-.8, ) -.0 (-.4, -2.7) -. (-.7, -.0) -.7 (-4.0, -.4) -6.4 (-7.8, -5.0) -8.8 (-10.0, - 7.5) -9.5 (-10.8, - 8.) -7.1 (-8.2, -6.0) Score 41.2 (8.4, 4.9) 10.7 (8., 1.0) 6.4 (4., 8.5) 6.4 (4., 8.5) 5. (4.9, 5.6) 1.7 (1., 2.0) 1.4 (1.0, 1.7) 1.2 (0.86, 1.5) 1.8 (11.7, 15.8) 5.0 (.7, 6.).2 (1.9, 4.4).2 (2.0, 4.5) 14.7 (1.7, 15.7) 7.1 (6.0, 8.2) Change from -0.2 (-2.6, ) -4.5 (-6.5, - 2.5) -4.5 (-6.6, - 2.4) -.5 (-.9, -.2) -.8 (-4.2, -.5) -4.0 (-4., -.7) -9.0 (-10., - 7.6) (-12.0, - 9.5) (-12.0, - 9.4) -7.9 (-9.0, -6.9) Difference Between Groups g p value -.7 (-7.1, - 0.9) -.7 (-6.4, - 0.9) -2.7 (-5.7, 0.25) (-0.97, ) (-0.95, ) (-0.75, 0.15) (-4.5, ) (-.8, ) (-.0, 0.6) (-2.4, 0.67) 0.27
8 FABQ Work e (0-42 scale with fear-avoidance beliefs related to work activity) EQ-5D Comprehensive Health Score f (0-1 scale with preference for health state) EQ-5D Overall Health Self-Rating c (0-100 scale with self-rated health) 5.8 (4.8, 6.8) (4.6, 7.0) Baselin e 12. (10.4, 14.2) 4 Week 9.2 (7.9, 10.6) 7.6 (6., 8.9) 1 6. (5.0, 7.6) 0.66 (0.6, 0.70) 4 Week 0.84 (0.82, 0.87) 0.88 (0.85, 0.90) (0.86, 0.90) 66.4 (62.8, 70.0) 4 Week 72.9 (69.7, 76.1) 7.7 (70.2, 77.2) (72.2, 79.0) -9.2 (-10.2, - 8.2) -9.2 (-10.4 to - 8.0) -2.6 (-.9, -1.2) -4.2 (-5.5, -2.9) -5.5 (-6.8, -4.2) 0.18 (0.16, 0.21) 0.22 (0.19, 0.24) 0.22 (0.20, 0.24) 5.2 (2.0, 8.4) 6.1 (2.6, 9.6) 7.9 (4.5, 11.4) 5.2 (4.1, 6.2) 5.6 (4., 6.8) 11. (9.5, 1.0) 7.9 (6.6, 9.) 5.2 (.9, 6.6) 5.1 (.8, 6.5) 0.66 (0.62, 0.69) 0.87 (0.85, 0.90) 0.91 (0.89, 0.9) 0.92 (0.90, 0.94) 69.0 (65.8, 72.2) 78. (75.0, 81.5) 79. (75.7, 82.9) 81. (77.9, 84.7) -9.9 (-10.9, - 8.8) -9.5 (-10.7, - 8.2) -.9 (-5.2, -2.5) -6.6 (-7.9, -5.2) -6.7 (-8.0, -5.) 0.21 (0.19, 0.24) 0.25 (0.2, 0.27) 0.26 (0.24, 0.28) 10.6 (7.4, 1.9) 11.7 (8.1, 15.) 1.6 (10.2, 17.1) (-2.1, 0.79) (-2.0, 1.5) (-.2, 0.56) (-4.2, ) (-.1, 0.70) 0.0 (0.0, 0.07) 0.0 (0.0, 0.06) (0.01, 0.07) 5.4 (0.8, 10.0) 5.6 (0.54, 10.7) 5.7 (0.90, 10.5) a 0 missing scores at baseline, 6 at 4-weeks, 4 at -months, and 12 at 1-year and imputed using multiple b missing scores at baseline, 6 at 4-weeks, 4 at -months, and 10 at 1-year and imputed using multiple c 1 missing score at baseline, 5 at 4-weeks, 5 at -months, and 11 at 1-year and imputed using multiple d 0 missing scores at baseline, 4 at 4-weeks, 5 at -months, and 11 at 1-year and imputed using multiple e 0 missing scores at baseline, 6 at 4-weeks, 5 at -months, and 11 at 1-year and imputed using multiple f 1 missing score at baseline, 5 at 4-weeks, 7 at -months, and 11 at 1-year and imputed using multiple g differences are adjusted for baseline scores of outcome variable
9 etable. Early Physical Therapy vs. Usual Care Differences in Dichotomous Secondary Outcomes Early Physical Usual Care Relative Risk p value d Therapy (N (%) (95% CI) (N (%) participants) participants) Patient-Reported Success (15-point likert scale; self-ratings of a great deal better or a very great deal better defined as success) a 4 Weeks 59 (57.8%) 48 (4.5%) 1. (1.01, 1.75) s 62 (61.0%) 46 (42.0%) 1.45 (1.10, 1.91) (62.%) 58 (52.6%) 1.18 (0.9, 1.50) 0.17 Healthcare Utilization Outcomes b Emergency Department or Urgent Care Visit p value c 4 Weeks 0 1 (0.9%) 12 Weeks 2 (2.0%) 2 (1.8%) (7.8%) 10 (9.2%) 0.7 Advanced Imaging 4 Weeks 0 0 s 1 (1.0%) 0 (0%) 2 (2.0%) (2.8%) 0.68 Spine Specialist Physician Visit 4 Weeks 0 1 (0.9%) s 2 (2.0%) 5 (4.6%) 7 (6.6%) 12 (10.7%) Spine Injection 4 Weeks 0 0 s 1 (1.0%) 1 (0.9%) (0.9%) 4 (.7%) 0.12 Spine Surgery 4 Weeks 0 0 s (1.9%) 0 a 6 missing scores at 4-weeks, 5 at -months, and 12 at 1-year imputed using multiple b 156 participants (70.9% completed 12 monthly diaries reporting utilization outcomes, 196 (89.1%) completed 10 or more, 206 (9.6%) completed 8 or more. c p values from Fisher exact tests. 1
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