Table 4.
Primary analysis results for years 3 and 4. Intent-to-treat for the randomized cohort and adjusted* analyses according to treatment received for the randomized and observational cohorts combined. ‡‡
| Baseline | 2-Year | 3-Year | 4-Year | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
|
|
||||||||||
| Overall Mean |
Mean Change (SE) or percent |
Mean Change (SE) or percent |
Mean Change (SE) or percent |
|||||||
|
|
|
|
||||||||
| Surgery | Non- Operative |
Treatment Effect (95% CI)† |
Surgery | Non- Operative |
Treatment Effect (95% CI)† |
Surgery | Non- Operative |
Treatment Effect (95% CI)† |
||
|
RCT Intent-to-treat
Primary Outcomes |
(n = 109) | (n = 114) | (n = 106) | (n = 103) | (n = 92) | (n = 96) | ||||
|
| ||||||||||
| SF-36 Bodily Pain (BP) (0-100) (SE)‡ | 31.9 (1.1) | 23.2 (2.3) | 15.4 (2.2) | 7.8 (1.4, 14.1) |
21 (2.4) | 16.6 (2.3) | 4.4 (−2.1, 10.9) |
15.9 (2.4) | 15.7 (2.4) | 0.3 (−6.4, 7) |
|
| ||||||||||
| SF-36 Physical Function (PF) (0-100) (SE)‡ |
35.4 (1.4) | 16.7 (2.4) | 17 (2.3) | −0.3 (−6.7, 6.1) |
17.1 (2.4) | 14.4 (2.3) | 2.6 (−4, 9.2) | 12.7 (2.5) | 15.9 (2.4) | −3.2 (−9.9, 3.6) |
|
| ||||||||||
| Oswestry Disability Index (ODI) (0-100) (SE)§ |
42.7 (1.1) | −16.1 (1.9) | −12.7 (1.8) | −3.4 (−8.5, 1.8) |
−14.7 (2) | −13.3 (1.9) |
−1.4 (−6.8, 3.9) |
−12.2 (2) | −12.4 (1.9) | 0.2 (−5.2, 5.7) |
|
| ||||||||||
| Secondary Outcomes | ||||||||||
|
| ||||||||||
| Sciatica Bothersomeness Index (0-24) (SE)¶ |
13.9 (0.35) | −6 (0.71) | −5.4 (0.69) | −0.5 (−2.5, 1.4) |
−6 (0.73) | −4.9 (0.71) |
−1 (−3.1, 1) | −5.2 (0.75) |
−4.5 (0.73) | −0.7 (−2.8, 1.4) |
|
| ||||||||||
| Leg pain (0-6) (SE)∥ | 4.3 (0.1) | −2 (0.2) | −1.8 (0.2) | −0.2 (−0.8, 0.4) |
−2.2 (0.2) | −1.6 (0.2) | −0.6 (−1.2, 0) | −1.8 (0.2) | −1.8 (0.2) | 0 (−0.7, 0.6) |
|
| ||||||||||
| Low back pain bothersomeness (0-6) (SE)** |
4 (0.1) | −1.2 (0.2) | −1.6 (0.2) | 0.4 (−0.2, 0.9) |
−1.2 (0.2) | −1.3 (0.2) | 0.1 (−0.4, 0.7) | −0.9 (0.2) | −1.3 (0.2) | 0.4 (−0.2, 1) |
|
| ||||||||||
| Very/somewhat satisfied w/ symptoms (%) |
5 (2.2) | 53.1 | 43.3 | 9.8 (−3.3, 22.9) |
56.6 | 45.2 | 11.5 (−2.1, 25.1) |
48.2 | 43.8 | 4.5 (−9.6, 18.6) |
|
| ||||||||||
| Very/somewhat satisfied w/ care(%) | 75.9 | 67.6 | 8.3 (−3.6, 20.2) |
79.6 | 62.8 | 16.8 (4.5, 29.2) |
69.4 | 70.6 | −1.2 (− 14.5, 12.2) |
|
|
| ||||||||||
| Self-rated progress: major improvement (%) |
49.4 | 43.5 | 5.9 (−7.3, 19.2) |
47.2 | 42.7 | 4.5 (−9.1, 18.2) |
42.3 | 33.9 | 8.3 (−5.4, 22.1) |
|
|
RCT/OC As-treated
Primary Outcomes |
(n = 350) | (n = 199) | (n = 326) | (n = 171) | (n = 275) | (n = 144) | ||||
|
| ||||||||||
| SF-36 Bodily Pain (BP) (0-100) (SE)‡ | 31.4 (0.6) | 27 (1.2) | 12.9 (1.5) | 14 (10.5, 17.6) |
26.8 (1.2) | 13.4 (1.6) | 13.4 (9.6, 17.1) |
25.1 (1.3) | 12.5 (1.7) | 12.6 (8.5, 16.7) |
|
| ||||||||||
| SF-36 Physical Function (PF) (0-100) (SE)‡ |
34.9 (0.8) | 22.2 (1.3) | 12.7 (1.5) | 9.5 (6, 13) | 20.9 (1.3) | 10.4 (1.6) | 10.4 (6.7, 14.1) |
20.3 (1.3) | 11.6 (1.7) | 8.6 (4.6, 12.6) |
|
| ||||||||||
| Oswestry Disability Index (ODI) (0-100) (SE)§ |
43.2 (0.6) | −20.3 (0.98) | −9.4 (1.2) | −10.9 (−13.7, -8.1) |
−18.6 (0.98) |
−9.1 (1.2) | −9.4 (−12.4, − 6.5) |
−18.7 (1.1) |
−9.3 (1.3) | −9.4 (−12.6, -6.2) |
|
| ||||||||||
| Secondary Outcomes | ||||||||||
|
| ||||||||||
| Sciatica Bothersomeness Index (0-24) (SE)¶ |
14.5 (0.2) | −8 (0.35) | −4.2 (0.43) | −3.8 (−4.9, − 2.8) |
−7.7 (0.35) | −4.4 (0.46) |
−3.2 (−4.3, − 2.1) |
−7.6 (0.39) |
−4.1 (0.49) | −3.5 (−4.7, − 2.3) |
|
| ||||||||||
| Leg pain (0-6) (SE)∥ | 4.3 (0.1) | −2.6 (0.1) | −1.3 (0.1) | −1.3 (−1.6, − 1) |
−2.5 (0.1) | −1.6 (0.1) | −1 (−1.3, -0.6) | −2.5 (0.1) | −1.4 (0.2) | −1.1 (−1.5, − 0.7) |
|
| ||||||||||
| Low back pain bothersomeness (0-6) (SE)** |
4.1 (0.1) | −2.1 (0.1) | −1 (0.1) | −1.1 (−1.4, − 0.8) |
−1.9 (0.1) | −0.9 (0.1) | −1 (−1.3, -0.7) | −1.8 (0.1) | −0.9 (0.1) | −0.8 (−1.2, − 0.5) |
|
| ||||||||||
| Very/somewhat satisfied w/ symptoms (%) |
5.8 (2.3) | 69.3 | 28.3 | 41 (32.5, 49.5) |
65.5 | 35.8 | 29.7 (20.4, 39.1) |
63.1 | 32.2 | 31 (20.9, 41) |
|
| ||||||||||
| Very/somewhat satisfied w/ care(%) | 82.5 | 66.2 | 16.3 (7.9, 24.6) |
83.6 | 61.8 | 21.9 (12.8, 30.9) |
77.8 | 63.6 | 14.3 (4.1, 24.5) |
|
|
| ||||||||||
| Self-rated progress: major improvement (%) |
63.6 | 27.9 | 35.8 (27.3, 44.2) |
61 | 28.5 | 32.5 (23.6, 41.4) |
52.8 | 23.1 | 29.6 (20.3, 39) |
|
Adjusted for center, age, gender, baseline score, income, treatment preference, duration of symptoms, compensation, smoking status, BMI, baseline Sciatica Bothersomeness, joint, stomach and bowel.
Treatment effect is the difference between the surgical and non-operative mean change from baseline.
The SF-36 scores range from 0 to 100, with higher score indicating less severe symptoms.
The Oswestry Disability Index ranges from 0 to 100, with lower scores indicating less severe symptoms
The Stenosis Bothersomeness Index ranges from 0 to 24, with lower scores indicating less severe symptoms
The Leg Pain Bothersomeness Scale ranges from 0 to 6, with lower scores indicating less severe symptoms
The Low Back Pain Bothersomeness Scale ranges from 0 to 6, with lower scores indicating less severe symptoms
The sample sizes for the as-treated analyses reflect the number of patients contributing to the estimate in a given time-period using the longitudinal modeling strategy explained in the methods section, and may not correspond to the counts provided for each visit time in Figure 1.
The estimates for 1Y and 2Y for IDH RCT ITT differ slightly from those presented in NEJM paper (reference) due to modeling differences.