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:10.1001/jama.2015.11648.
eAppendix 1. Early Physical Therapy Protocol eAppendix 2. Per Protocol Secondary Analyses
eTable 1. Baseline Participant Characteristics Per-Protocol Secondary Analysis eTable 2. Early Physical Therapy vs Usual Care: Primary and Secondary Outcomes Per-Protocol Analysis
eTable 3. 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.
eAppendix 1. Early Physical Therapy Protocol INTERVENTION Baseline assessment Session 1 (within 72 hours) Session 2 (2-3 days later) Session 3 (1 week later) Session 4 (1 week later) Advice and Education
X As needed As needed As needed As needed Spinal Manipulation X X Spinal Range of Motion Exercise X X Spinal Strengthening Exercise 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
Spinal Range of Motion Exercises: Patients were instructed to perform supine pelvic tilting or
quadruped spinal range of motion (fig. 3) 3-4 times throughout the day. Patients were instructed to move through the greatest range of motion possible.
Spinal Strengthening Exercises: Thestrengthening 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.
Additional Contributions: We thank the patients for granting permission to publish this information.
eAppendix 2. Per protocol secondary analyses
Subjects were excluded in the per-protocol analyses for the following reasons:
3 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 3 sessions and receive spinal manipulation in sessions 1 and 2, and some exercise in sessions 3 and 4 (if applicable).
eTable 1. Baseline Participant Characteristics Per-Protocol Secondary Analysis Usual Care
(n = 110)
Early Physical Therapy (n = 102)
Age (mean (sd) years) 36.5 (10.2) 38.2 (10.4)
Female gender (n, %) 52 (47.3%) 60 (58.8%) Race/Ethnicity (n, %) White Hispanic African American Other/multi-racial 87 (79.1%) 13 (11.8%) 2 (1.8%) 8 (7.3%) 83 (81.4%) 5 (4.9%) 3 (2.9%) 11 (10.8%) Body mass index (mean (sd) kg/m2) 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
108 (98.2%) 47 (42.7%)
100 (98.0%) 55 (53.9%) Employment status (n, %, employed
outside the home)
90 (81.8%) 86 (84.3%)
Co-Morbid Health Conditions (n, %) Diabetes
Hypertension Anxiety/Depression Upper back /neck pain
5 (4.5%) 9 (8.2%) 31 (28.2%) 38 (34.5%) 2 (2.0%) 7 (6.9%) 24 (23.5%) 39 (38.2%) Current Medications for Back Pain (n, %)
Non-steroidal anti-inflammatory Opioids Muscle relaxers Steroid anti-inflammatory Other 72 (65.5%) 30 (27.3%) 59 (53.6%) 15 (13.6%) 8 (7.3%) 69 (67.6%) 27 (26.5%) 59 (57.8%) 10 (9.8%) 3 (2.9%) Current Smoker (n, %) 7 (6.4%) 9 (8.8%)
%)
Oswestry Disability Index Score (mean, sd)
40.6 (12.0) 41.2 (14.1)
Numeric Pain Rating (mean, sd)a 5.1 (1.9) 5.3 (1.8)
Fear-Avoidance Beliefs (mean, sd) Physical Activity Subscale Work Subscale
15.3 (4.9) 12.3 (10.2)
14.7 (5.1) 11.3 (9.0) Pain Catastrophizing Scale (mean, sd) b 14.1 (10.2) 13.8 (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
3 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
eTable 2. Early Physical Therapy vs. Usual Care: Primary and Secondary Outcomes Per-Protocol Analysis
Outcome: Usual Care Early Intervention Visit Mean Score Mean Change from Baseline Mean Score Mean Change from Baseline Mean Difference Between Groupsg p value PRIMARY OUTCOME: Oswestry Disability Index Scorea (0-100 scale with higher scores indicating worse function) Baseline 40.6 (38.4, 42.9) 41.2 (38.4, 43.9) . . 4 Week 14.4 (12.0, 16.8) -26.5 (28.9, -24.1) 10.7 (8.3, 13.0) -30.2 (32.6, -27.9) -3.7 (7.1, -0.39) 0.029 3 Month (8.1, 10.1 12.0) -30.8 (32.7, -28.9) 6.4 (4.3, 8.5) -34.5 (36.5, -32.5) -3.7 (6.4, -0.93) 0.009 1 Year 9.1 (6.7, 11.2) -31.8 (33.8, -29.7) 6.4 (4.3, 8.5) -34.5 (36.6, -32.4) -2.7 (-5.7, 0.25) 0.072 SECONDARY OUTCOMES: Numeric Pain Ratingb (0-10 scale with higher scores indicating greater pain intensity) Baseline (4.7, 5.1 5.4) 5.3 (4.9, 5.6) . . 4 Week 2.2 (1.8, 2.5) -3.0 (-3.4, -2.7) 1.7 (1.3, 2.0) -3.5 (-3.9, -3.2) -0.49 (-0.97, -0.01) 0.046 3 Month 1.8 (1.5, 2.2) -3.3 (-3.7, -3.0) 1.4 (1.0, 1.7) -3.8 (-4.2, -3.5) -0.48 (-0.95, -0.01) 0.044 1 Year 1.5 (1.2, 1.8) -3.7 (-4.0, -3.4) 1.2 (0.86, 1.5) -4.0 (-4.3, -3.7) -0.30 (-0.75, 0.15) 0.19 Pain Catastrophizing Scalec (0-52 scale with higher scores indicating greater pain-catastrophizing beliefs) Baseline 14.1 (12.2, 16.1) 13.8 (11.7, 15.8) . . 4 Week 7.6 (6.2, 9.0) -6.4 (-7.8, -5.0) 5.0 (3.7, 6.3) -9.0 (10.3, -7.6) -2.6 (-4.5, -0.69) 0.008 3 Month 5.2 (4.0, 6.4) -8.8 (10.0, -7.5) 3.2 (1.9, 4.4) -10.8 (12.0, -9.5) -2.0 (-3.8, -0.29) 0.022 1 Year 4.4 (3.1, 5.7) -9.5 (10.8, -8.3) 3.2 (2.0, 4.5) -10.7 (12.0, -9.4) -1.2 (-3.0, 0.63) 0.20 FABQ Physical Activityd (0-24 scale with higher scores indicating greater fear-avoidance beliefs related to physical activity) Baseline 15.3 (14.4, 16.2) 14.7 (13.7, 15.7) . . 4 Week 7.9 (6.9, 9.0) -7.1 (-8.2, -6.0) (6.0, 7.1 8.2) -7.9 (-9.0, -6.9) (-2.4-0.84 , 0.67) 0.27
3 Month (4.8, 5.8 6.8) -9.2 (10.2, -8.2) 5.2 (4.1, 6.2) -9.9 (10.9, -8.8) -0.66 (-2.1, 0.79) 0.37 1 Year 5.8 (4.6, 7.0) -9.2 (10.4 to -8.0) 5.6 (4.3, 6.8) -9.5 (10.7, -8.2) -0.27 (-2.0, 1.5) 0.76 FABQ Worke (0-42 scale with higher scores indicating greater fear-avoidance beliefs related to work activity) Baselin e (10.4, 12.3 14.2) 11.3 (9.5, 13.0) . . 4 Week 9.2 (7.9, 10.6) -2.6 (-3.9, -1.2) 7.9 (6.6, 9.3) -3.9 (-5.2, -2.5) -1.3 (-3.2, 0.56) 0.17 3 Month (6.3, 7.6 8.9) -4.2 (-5.5, -2.9) 5.2 (3.9, 6.6) -6.6 (-7.9, -5.2) -2.4 (4.2, -0.47) 0.014 1 Year 6.3 (5.0, 7.6) -5.5 (-6.8, -4.2) 5.1 (3.8, 6.5) -6.7 (-8.0, -5.3) -1.2 (-3.1, 0.70) 0.22 EQ-5D Comprehensive Health Scoref (0-1 scale with higher scores indicating greater preference for health state) Baseline 0.66 (0.63, 0.70) 0.66 (0.62, 0.69) . . 4 Week 0.84 (0.82, 0.87) 0.18 (0.16, 0.21) 0.87 (0.85, 0.90) 0.21 (0.19, 0.24) 0.03 (0.0, 0.07) 0.063 3Month 0.88 (0.85, 0.90) 0.22 (0.19, 0.24) 0.91 (0.89, 0.93) 0.25 (0.23, 0.27) 0.03 (0.0, 0.06) 0.045 1 Year 0.88 (0.86, 0.90) 0.22 (0.20, 0.24) 0.92 (0.90, 0.94) 0.26 (0.24, 0.28) 0.04 (0.01, 0.07) 0.020 EQ-5D Overall Health Self-Ratingc (0-100 scale with higher scores indicating greater self-rated health) Baseline 66.4 (62.8, 70.0) 69.0 (65.8, 72.2) . . 4 Week 72.9 (69.7, 76.1) 5.2 (2.0, 8.4) 78.3 (75.0, 81.5) 10.6 (7.4, 13.9) 5.4 (0.83, 10.0) 0.021 3Month 73.7 (70.2, 77.2) 6.1 (2.6, 9.6) 79.3 (75.7, 82.9) 11.7 (8.1, 15.3) 5.6 (0.54, 10.7) 0.030 1 Year 75.6 (72.2, 79.0) 7.9 (4.5, 11.4) 81.3 (77.9, 84.7) 13.6 (10.2, 17.1) 5.7 (0.90, 10.5) 0.020
a 0 missing scores at baseline, 6 at 4-weeks, 4 at 3-months, and 12 at 1-year and imputed using multiple
imputation procedure
b 3 missing scores at baseline, 6 at 4-weeks, 4 at 3-months, and 10 at 1-year and imputed using multiple
imputation procedure
c 1 missing score at baseline, 5 at 4-weeks, 5 at 3-months, and 11 at 1-year and imputed using multiple
imputation procedure
d 0 missing scores at baseline, 4 at 4-weeks, 5 at 3-months, and 11 at 1-year and imputed using multiple
imputation procedure
e 0 missing scores at baseline, 6 at 4-weeks, 5 at 3-months, and 11 at 1-year and imputed using multiple
imputation procedure
f 1 missing score at baseline, 5 at 4-weeks, 7 at 3-months, and 11 at 1-year and imputed using multiple
imputation procedure g
eTable 3. Early Physical Therapy vs. Usual Care Differences in Dichotomous Secondary Outcomes Early Physical Therapy (N (%) participants) Usual Care (N (%) participants) Relative Risk (95% CI) p valued
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 (43.5%) 1.33 (1.01, 1.75) 0.041 3 Months 62 (61.0%) 46 (42.0%) 1.45 (1.10, 1.91) 0.008 1 Year 64 (62.3%) 58 (52.6%) 1.18 (0.93, 1.50) 0.17 Healthcare Utilization Outcomesb
Emergency Department or Urgent Care Visit p valuec 4 Weeks 0 1 (0.9%) 12 Weeks 2 (2.0%) 2 (1.8%) 1.0 Total at 1 Year 8 (7.8%) 10 (9.2%) 0.73 Advanced Imaging 4 Weeks 0 0 3 Months 1 (1.0%) 0 (0%) Total at 1 Year 2 (2.0%) 3 (2.8%) 0.68
Spine Specialist Physician Visit
4 Weeks 0 1 (0.9%) 3 Months 2 (2.0%) 5 (4.6%) Total at 1 Year 7 (6.6%) 12 (10.7%) Spine Injection 4 Weeks 0 0 3 Months 1 (1.0%) 1 (0.9%) 1.0 Total at 1 Year 1 (0.9%) 4 (3.7%) 0.12 Spine Surgery 4 Weeks 0 0 3 Months 0 0 Total at 1 Year 2 (1.9%) 0
a 6 missing scores at 4-weeks, 5 at 3-months, and 12 at 1-year imputed using multiple imputation procedure
b 156 participants (70.9% completed 12 monthly diaries reporting utilization outcomes, 196 (89.1%)
completed 10 or more, 206 (93.6%) completed 8 or more.
