Table 7.
Outcome |
Duration of Symptoms |
1-Year |
2-Year |
3-Year |
4-Year |
||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
DS | Surgical | Non- operative |
Treatment Effect† (95% CI) |
Surgical | Non- operative |
Treatment Effect† (95% CI) |
Surgical | Non- operative |
Treatment Effect† (95% CI) |
Surgical | Non- perative |
Treatment Effect† (95% CI) |
|
Primary Outcomes |
|||||||||||||
SF-36 Bodily Pain (BP) (0–100) (SE) |
One year or less |
34.8 (1.8) | 14 (1.7) | 20.8 (16, 25.5) |
32.4 (1.8) | 14 (1.9) | 18.4 (13.4, 23.5) |
34.3 (1.8) | 16.1 (2) | 18.2 (12.9, 23.5) |
32.2 (1.9) | 16.2 (2.2) | 16 (10.3, 21.7) |
More than 1 year |
30.3 (1.7) | 13.3 (2.5) | 17 (11.3, 22.6) |
31.2 (1.6) | 11.3 (2.6) | 19.9 (14.1, 25.7) |
30.7 (1.6) | 13.3 (2.9) | 17.4 (11.1, 23.7) |
29.9 (1.8) | 15 (3) | 14.9 (8.3, 21.5) |
|
pvalue | 0.065 | 0.81 | 0.31 | 0.59 | 0.40 | 0.71 | 0.12 | 0.42 | 0.84 | 0.35 | 0.73 | 0.80 | |
SF-36 Physical Function (PF) (0–100) (SE) |
One year or less |
29.3 (1.7) | 11.6 (1.6) | 17.7 (13.2, 22.3) |
25.7 (1.7) | 10 (1.8) | 15.7 (10.9, 20.5) |
24.9 (1.8) | 9.9 (1.9) | 15.1 (10, 20.1) |
26.6 (1.9) | 8.9 (2.1) | 17.6 (12.2, 23.1) |
More than 1 year |
27.2 (1.7) | 9 (2.4) | 18.1 (12.8, 23.5) |
25.9 (1.6) | 8.6 (2.5) | 17.3 (11.8, 22.8) |
25 (1.6) | 7.3 (2.8) | 17.7 (11.7, 23.7) |
25.8 (1.7) | 6.9 (2.9) | 18.8 (12.5, 25.1) |
|
pvalue | 0.37 | 0.36 | 0.90 | 0.93 | 0.64 | 0.66 | 0.97 | 0.45 | 0.51 | 0.74 | 0.57 | 0.78 | |
Mental Component Summary (MCS) (0–100) (SE) |
One year or Less |
3.4 (0.7) | 1.7 (0.7) | 1.8 (−0.2, 3.8) |
2.8 (0.7) | 1.3 (0.8) | 1.5 (−0.6, 3.6) |
2.1 (0.8) | 0.3 (0.8) | 1.7 (−0.5, 4) |
2.5 (0.8) | 1 (1) | 1.5 (−1, 4) |
More than 1 year |
2.5 (0.7) | 1 (1) | 1.5 (−0.9, 3.9) |
2.4 (0.7) | 0 (1.1) | 2.4 (−0.1, 4.9) |
2.9 (0.7) | −0.2 (1.2) | 3.1 (0.4, 5.8) |
2.1 (0.8) | −1.6 (1.3) | 3.7 (0.7, 6.6) |
|
pvalue | 0.36 | 0.61 | 0.85 | 0.73 | 0.35 | 0.57 | 0.39 | 0.73 | 0.44 | 0.76 | 0.12 | 0.26 | |
Oswestry Disability Index (ODI) (0–100) (SE) |
One year or less |
−26.8 (1.3) | −8.1 (1.3) | −18.7 (−22.3, −15.2) |
−24.5 (1.3) | −8.6 (1.4) | −16 (−19.7, −12.2) |
−23.1 (1.4) | −10.5 (1.5) | −12.6 (−16.5, −8.7) |
−23.6 (1.4) | −9.8 (1.6) | −13.8 (−18, −9.6) |
More than 1 year |
−23.3 (1.3) | −6.6 (1.9) | −16.7 (−20.9, −12.6) |
−23.5 (1.2) | −6 (2) | −17.5 (−21.8, −13.1) |
−20.9 (1.2) | −5.6 (2.2) | −15.3 (−20, −10.6) |
−22.1 (1.3) | −6 (2.2) | −16.2 (−21, −11.3) |
|
pvalue | 0.055 | 0.48 | 0.48 | 0.54 | 0.29 | 0.60 | 0.20 | 0.063 | 0.39 | 0.44 | 0.16 | 0.46 | |
Secondary Outcomes |
|||||||||||||
Stenosis Bothersomeness Index (0–24) (SE) |
One year or less |
−9.5 (0.5) | −3.9 (0.5) | −5.6 (−7, −4.2) | −9 (0.5) | −4.2 (0.5) | −4.8 (−6.2, −3.3) |
−9.4 (0.5) | −4.6 (0.6) | −4.9 (−6.4, −3.3) |
−9.1 (0.5) | −4.2 (0.6) | −4.8 (−6.5, −3.2) |
More than 1 year |
−9.5 (0.5) | −4 (0.7) | −5.5 (−7, −4) | −9.1 (0.4) | −3.3 (0.7) | −5.8 (−7.4, −4.2) |
−8.8 (0.5) | −3.7 (0.8) | −5.1 (−6.8, −3.3) |
−9.1 (0.5) | −2.7 (0.8) | −6.4 (−8.2, −4.6) |
|
pvalue | 0.98 | 0.90 | 0.91 | 0.89 | 0.30 | 0.36 | 0.35 | 0.40 | 0.87 | 0.90 | 0.15 | 0.20 | |
Low Back Pain Bothersomeness (0–6) (SE) |
One year or less |
−2.3 (0.1) | −1.1 (0.1) | −1.2 (−1.6, −0.8) |
−2.1 (0.1) | −1.4 (0.1) | −0.8 (−1.2, −0.4) |
−2.2 (0.1) | −1.5 (0.2) | −0.7 (−1.1, −0.3) |
−2.1 (0.2) | −1.2 (0.2) | −0.9 (−1.4, −0.4) |
More than 1 year |
−2.4 (0.1) | −1.1 (0.2) | −1.3 (−1.7, −0.9) |
−2.1 (0.1) | −0.9 (0.2) | −1.3 (−1.8, −0.8) |
−2 (0.1) | −1.1 (0.2) | −0.9 (−1.4, −0.4) |
−2 (0.1) | −1 (0.2) | −1.1 (−1.6, −0.6) |
|
pvalue | 0.80 | 0.93 | 0.91 | 0.93 | 0.032 | 0.11 | 0.28 | 0.16 | 0.64 | 0.66 | 0.39 | 0.67 | |
Leg pain (0–6) (SE) |
One year or less |
−3 (0.2) | −1.5 (0.1) | −1.5 (−1.9, −1.1) |
−2.8 (0.2) | −1.6 (0.2) | −1.3 (−1.8, −0.8) |
−3 (0.2) | −1.7 (0.2) | −1.3 (−1.8, −0.8) |
−3.1 (0.2) | −1.7 (0.2) | −1.4 (−1.9, −0.9) |
More than one year |
−3.1 (0.1) | −1.4 (0.2) | −1.6 (−2.1, −1.1) |
−3 (0.1) | −1.2 (0.2) | −1.8 (−2.3, −1.3) |
−2.9 (0.1) | −1.5 (0.2) | −1.4 (−2, −0.8) | −3 (0.2) | −1.2 (0.3) | −1.8 (−2.4, −1.2) |
|
pvalue | 0.86 | 0.77 | 0.72 | 0.48 | 0.087 | 0.074 | 0.61 | 0.55 | 0.83 | 0.63 | 0.15 | 0.34 | |
Very/somewhat satisfied with symptoms (%) |
One year or less |
76.4 | 31.8 | 44.6 (34.6, 54.7) |
73.3 | 35.9 | 37.5 (26.3, 48.6) |
69.5 | 39.5 | 30 (17.7, 42.3) |
66.6 | 29.7 | 36.9 (24.2, 49.6) |
More than 1 year |
69.3 | 16.5 | 52.8 (42, 63.7) |
65.7 | 24.5 | 41.2 (28.7, 53.7) |
63 | 28.5 | 34.5 (20.4, 48.6) |
60.3 | 28.4 | 32 (16.6, 47.3) |
|
pvalue | 0.19 | 0.024 | 0.29 | 0.15 | 0.15 | 0.69 | 0.25 | 0.21 | 0.67 | 0.31 | 0.89 | 0.70 | |
Self-rated pogress major mprovement (%) |
One year or less |
78.2 | 28.2 | 50 (40.2, 59.8) |
72 | 26.8 | 45.2 (34.4, 56) |
73.9 | 28.4 | 45.5 (34.1, 56.8) |
68.3 | 27.9 | 40.5 (27.8, 53.1) |
More than 1 year |
72.6 | 19.8 | 52.8 (41.4, 64.2) |
73.8 | 17.8 | 56.1 (44.8, 67.3) |
67.5 | 18.5 | 49.1 (36.5, 61.7) |
63.7 | 9.1 | 54.7 (43.4, 66) |
|
pvalue | 0.29 | 0.23 | 0.73 | 0.72 | 0.20 | 0.20 | 0.25 | 0.25 | 0.64 | 0.45 | 0.052 | 0.12 |
Adjusted for age, gender, BMI, race, smoking status, compensation, joint, stomach, bowel, osteoporosis, number of moderate/severe stenotic levels, self-assessed health trend at baseline, treatment preference, baseline stenosis bothersomeness, other ** comorbiditiy, baseline score and center.
Other comorbidities include: stroke, cancer, fibromyalgia, cfs, PTSD, alcohol, drug dependency, lung, liver, kidney, blood vessel, nervous system, migraine, anxiety
Treatment effect is the difference between the surgical and non-operative mean change from baseline. Analysis is done using a mixed model with a random subject intercept term. Treatment is a time-varying covariate where a patients' experience prior to surgery is attributed to the non-operative arm and time is measured from enrollment and his/her post-surgery outcomes are attributed to the surgical arm and time is measured from time of surgery.