Table 1.
Patient Baseline Demographic Characteristics, Comorbid Conditions, Clinical Findings, and Health Status Measures.
| Characteristics IDH (RCT & OBS) |
Non-Opioid (n=520) | Opioid (n=542)* | p-value |
|---|---|---|---|
| Mean Age (SD) | 41.8 (11.5) | 41.8 (10.9) | 0.97 |
| Female - no.(%) | 212 (41%) | 245 (45%) | 0.16 |
| Ethnicity: Not Hispanic† | 497 (96%) | 518 (96%) | 0.88 |
| Race - White† | 446 (86%) | 479 (88%) | 0.24 |
| Education - At least some college | 406 (78%) | 384 (71%) | 0.009 |
| Income - Under $50,000 | 224 (43%) | 252 (46%) | 0.29 |
| Marital Status - Married | 366 (70%) | 385 (71%) | 0.87 |
| Work Status | <0.001 | ||
| Full or part time | 352 (68%) | 283 (52%) | |
| Disabled | 49 (9%) | 100 (18%) | |
| Other | 119 (23%) | 158 (29%) | |
| Compensation - Any‡ | 66 (13%) | 129 (24%) | <0.001 |
| Mean Body Mass Index (BMI), (SD)§ | 27.4 (5.2) | 28.6 (5.8) | <0.001 |
| Smoker | 99 (19%) | 158 (29%) | <0.001 |
| Comorbidities - no.(%) | |||
| Depression | 60 (12%) | 72 (13%) | 0.44 |
| Joint Problem | 95 (18%) | 106 (20%) | 0.65 |
| Diabetes | 19 (4%) | 25 (5%) | 0.53 |
| Other¶ | 208 (40%) | 271 (50%) | 0.001 |
| Time since recent episode < 6 months | 403 (78%) | 431 (80%) | 0.47 |
| SF-36 scores, mean (SD)†† | |||
| Bodily Pain (BP) | 32.8 (21.1) | 19.5 (15.1) | <0.001 |
| Physical Functioning (PF) | 44.6 (25) | 28.9 (22.8) | <0.001 |
| Mental Component Summary (MCS) | 46.6 (11.5) | 43 (11.3) | <0.001 |
| Physical Component Summary (PCS) | 32.6 (8.5) | 27.8 (7.3) | <0.001 |
| Oswestry (ODI) (SD)‡‡ | 43 (20.3) | 58.5 (18.5) | <0.001 |
| Sciatica Frequency Index (0–24) (SD)§§ | 14.5 (5.4) | 17.4 (4.8) | <0.001 |
| Sciatica Bothersome Index (0–24) (SD)§§ | 14.4 (5.2) | 17.1 (4.8) | <0.001 |
| Back Pain Bothersomeness (0–6)(SD)¶¶ | 3.7 (1.9) | 4.2 (1.9) | <0.001 |
| Satisfaction with symptoms - very dissatisfied | 391 (75%) | 480 (89%) | <0.001 |
| Patient self-assessed health trend - no.(%) | <0.001 | ||
| Getting better | 92 (18%) | 64 (12%) | |
| Staying about the same | 249 (48%) | 222 (41%) | |
| Getting worse | 178 (34%) | 251 (46%) | |
| Treatment preference at baseline - no.(%) | <0.001 | ||
| Preference for non-surg | 209 (40%) | 132 (24%) | |
| Not sure | 93 (18%) | 82 (15%) | |
| Preference for surgery | 217 (42%) | 326 (60%) | |
| Pain Radiation | 506 (97%) | 530 (98%) | 0.76 |
| Straight Leg Raise Test - Ipsilateral | 311 (60%) | 365 (67%) | 0.013 |
| Straight Leg Raise Test - Contralateral/Both | 79 (15%) | 90 (17%) | 0.59 |
| Any Neurological Deficit | 366 (70%) | 439 (81%) | <0.001 |
| Reflexes - Asymmetric Depressed | 195 (38%) | 227 (42%) | 0.16 |
| Sensory - Asymmetric Decrease | 234 (45%) | 307 (57%) | <0.001 |
| Motor - Asymmetric Weakness | 198 (38%) | 251 (46%) | 0.008 |
| Herniation Level | 0.36 | ||
| L2–L3/L3–L4 | 31 (6%) | 43 (8%) | |
| L4–L5 | 194 (37%) | 209 (39%) | |
| L5–S1 | 294 (57%) | 290 (54%) | |
| Herniation Type | 0.002 | ||
| Protruding | 162 (31%) | 123 (23%) | |
| Extruded | 328 (63%) | 370 (68%) | |
| Sequestered | 29 (6%) | 49 (9%) | |
| Posterolateral herniation | 400 (77%) | 423 (78%) | 0.72 |
| Received surgery** | 306 (59%) | 407 (75%) | <0.001 |
Race or ethnic group was self-assessed. Whites and blacks could be either Hispanic or non-Hispanic.
This category includes patients who were receiving or had applications pending for workers compensation, Social Security compensation, or other compensation.
The body-mass index is the weight in kilograms divided by the square of the height in meters.
Other indicates problems related to stroke, diabetes, osteoporosis, cancer, fibromyalgia, chronic fatigue syndrome (CFS), post traumatic stress disorder (PTSD), alcohol, drug dependence, heart, lung, liver, kidney, blood vessel, nervous system, hypertension, migraine, anxiety, stomach or bowel.
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 Sciatica Bothersomeness index range from 0 to 24, with lower scores indicating less severe symptoms.
The Low Back Pain Bothersomness Scale ranges from 0 to 6, with lower scores indicating less severe symptoms.
Among total of 1244 IDH patients, 541 did not use opioid at enrollment (Non-Opioid group), 567 used opioid at enrollment (Opioid group), and 136 had no information. 520 out of 541 Non-Opioid patients and 542 out of 567 Opioid patients had at least one follow-up through 4 years and were included in the current analysis dataset.
Received surgical treatment during the first 4 years of enrollment.