INTRODUCTION
METHODS
Design Overview
Study Setting
Participants
Interventions
Randomization and Treatment Arms
Outcomes and Follow-up
Statistical Methods
Handling of Missing Data
RESULTS
Participant Flow
Participant Baseline Characteristics
Demographic variable | Group (n = 389) | Individual (n = 390) | p value | Total (n = 779) |
---|---|---|---|---|
Age, mean (SD) | 54.2 (13.8) | 55.4 (13.2) | 0.19 | 54.8 (13.5) |
Sex (n (%)) | 0.73 | |||
Female | 315 (81.0%) | 312 (80.0%) | 627 (80.5%) | |
Male | 74 (19.0%) | 78 (20.0%) | 152 (19.5%) | |
Spoken language (n (%)) | 0.9* | |||
English | 292 (78.7%) | 290 (78.0%) | 582 (78.3%) | |
Spanish | 79 (21.3%) | 81 (21.8%) | 160 (21.5%) | |
Other | 1 (0.3%) | 0 (0.0%) | 1 (0.1%) | |
Ethnicity (n (%)) | 0.34* | |||
Hispanic/Latino(a) | 219 (56.3%) | 224 (57.6%) | 443 (56.9%) | |
Non-Hispanic | 168 (43.2%) | 159 (40.9%) | 327 (42%) | |
Do not know | 2 (0.5%) | 6 (1.5%) | 8 (1.0%) | |
Race (n (%)) | 0.24* | |||
American Indian/Native | 15 (4.0%) | 22 (5.8%) | 37 (4.9%) | |
Asian | 6 (1.5%) | 4 (1%) | 10 (1.3%) | |
Black/African American | 141 (36.3%) | 134 (34.4%) | 275 (35.3%) | |
White | 46 (11.8%) | 58 (14.9%) | 104 (13.4%) | |
Multiracial | 43 (11.1%) | 53 (13.5%) | 95 (12.3%) | |
Other | 138 (35.5%) | 119 (30.5%) | 257 (33%) | |
Working status (n (%)) | 0.24 | |||
Unable to work due to disability | 143 (36.8%) | 147 (37.7%) | 290 (37.2%) | |
Unemployed | 58 (14.9%) | 44 (11.3%) | 102 (13.1%) | |
Other (employed, retired, etc.) | 188 (48.3%) | 199 (51%) | 387 (49.7%) | |
Household income support (n (%)) | 0.40 | |||
Any Support | 114 (29.7%) | 103 (27.0%) | 217 (28.3%) | |
No Support | 270 (70.3%) | 279 (73.0%) | 549 (71.7%) | |
Receive SSI (n (%)) | 0.47 | |||
Yes | 177 (45.5%) | 217 (55.6%) | 394 (50.6%) | |
Health insurance (n (%)) | 0.78 | |||
Medicaid | 301 (77.4%) | 288 (73.8%) | 589 (75.6%) | |
Private | 76 (19.5%) | 88 (22.6%) | 164 (21.1%) | |
None | 8 (2.1%) | 8 (2.1%) | 16 (2.1%) | |
Other | 4 (1.0%) | 6 (1.5%) | 10 (1.3%) | |
Annual income (n (%)) | 0.37 | |||
< $20,000 | 183 (47.0%) | 179 (45.9%) | 362 (46.5%) | |
$20,000–$39,999 | 81 (20.8%) | 74 (19%) | 155 (19.9%) | |
> $40,000 | 42 (10.8%) | 57 (14.6%) | 99 (12.7%) | |
Do not know/refused | 83 (21.3%) | 80 (20.5%) | 163 (21%) | |
Opioid prescription by self-report (n (%)) | ||||
Yes | 106 (27.8%) | 93 (24.2%) | 0.26 | 199 (26.0%) |
Opioid prescription in EMR (n (%)) | ||||
Yes | ||||
Mean opioid MME | ||||
Referring condition (n (%)) | ||||
Back pain | 261 (67.1%) | 273 (70.0%) | 0.38 | 534 (68.5%) |
Neck pain | 70 (18.0%) | 68 (17.4%) | 0.84 | 138 (17.7%) |
Osteoarthritis | 94 (24.2%) | 112 (28.7%) | 0.15 | 206 (26.4%) |
2 or more | 77 (22.5%) | 91 (25.7%) | 0.33 | 168 (24.1%) |
PHQ-9 score, mean (SD) | 8.75 (6.02) | 8.74 (6.07) | 0.98 | 8.74 (6.04) |
Overall PROMIS Global Health Score (n (%)) | 0.95 | |||
Poor | 80 (20.6%) | 85 (21.8%) | 165 (21.2%) | |
Fair | 152 (39.1%) | 145 (37.3%) | 297 (38.2%) | |
Good | 111 (28.5%) | 104 (26.7%) | 215 (27.6%) | |
Very good | 33 (8.5%) | 42 (10.8%) | 75 (9.6%) | |
Excellent | 13 (3.3%) | 13 (3.3%) | 26 (3.3%) |
Participation in the Intervention by Arm
Group (n = 346) | Individual (n = 360) | Total (n = 779) | p value | |
---|---|---|---|---|
Mean (SD) | 8.0 (3.4) | 8.1 (3.4) | 8.1 (3.4) | 0.56 |
Median (Q1, Q3) | 9 (6, 11) | 9 (6, 11) | 9 (6, 11) | |
No. of treatments | ||||
0 | 43 (11%) | 30 (7.7%) | 73 (9.4%) | |
1–7 | 126 (36.4%) | 130 (36.1%) | 256 (36.3%) | 0.93 |
≥ 8 | 220 (63.6%) | 230 (63.9%) | 450 (63.7%) |
Primary Outcome
Outcome measure | Intent to treat | Per protocol (> 8 treatments) | ||||
---|---|---|---|---|---|---|
Group | Individual | Between group difference | Group | Individual | Between group difference | |
Baseline | ||||||
N | 385 | 385 | N/A | 219 | 229 | N/A |
Mean (SD) | 6.0 (2.7) | 6.1 (2.7) | 0.15 (p = 0.44) | 5.8 (2.6) | 5.8 (2.8) | 0.02 (p = 0.94) |
Range (min–max) | 0–10 | 0–10 | N/A | 0–10 | 0–10 | N/A |
12 weeks | ||||||
N | 279 | 297 | N/A | 194 | 209 | N/A |
Mean (SD) | 5.1 (3.0) | 4.8 (3.1) | − 0.33 (p = 0.19) | 4.6 (2.9) | 4.5 (3.1) | − 0.08 (p = 0.79) |
Mean change at 12 weeks from baseline (SD) | − 0.8 (2.6) | − 1.2 (2.6) | − 0.37 95% CI (− 0.77, 0.30) | − 1.1 (2.6) | −1.3 (2.7) | − 0.16 95% CI (− 0.65, 0.32) |
Responders (> 30% improvement) | 82 (30.3%) | 108 (37.5%) | 7.2% 95% CI (− 0.6%, 15.1%) | 65 (34.4%) | 81 (39.7%) | 5.3% 95% CI (− 4.2%, 14.9%) |
24 weeks | ||||||
N | 276 | 292 | N/A | 186 | 202 | N/A |
Mean (SD) | 5.3 (2.9) | 5.1 (3.1) | − 0.23 (p = 0.73) | 5.1 (3.0) | 4.7 (3.1) | − 0.36 (p = 0.44) |
Mean change at 24 weeks from Baseline (SD) | − 0.7 (2.5) | − 1.0 (2.5) | − 0.25 95% CI (− 0.66, 0.17) | − 0.8 (2.5) | − 1.1 (2.5) | − 0.31 95% CI (− 0.79, 0.17) |
Responders (> 30% improvement) | 77 (28.7%) | 99 (35.0%) | 6.3% 95% CI (− 1.5%, 14.0%) | 56 (30.8%) | 78 (39.6%) | 8.8% 95% CI (− 0.8%, 18.4%) |
Secondary Outcomes
Pain Severity
BPI pain severity | Intent to treat | Per protocol (> 8 treatments) | ||||
---|---|---|---|---|---|---|
Group | Individual | Between group difference | Group | Individual | Between group difference | |
Baseline | ||||||
N | 389 | 386 | N/A | 220 | 228 | N/A |
Mean (SD) | 6.8 (1.8) | 6.8 (1.9) | 0.01 (p = 0.96) | 6.7 (1.8) | 6.8 (1.9) | 0.01 (p = 0.94) |
Range | 0–10 | 1.5–10 | N/A | 1.5–10 | 1.5–10 | N/A |
12 weeks | ||||||
N | 285 | 301 | N/A | 201 | 213 | N/A |
Mean (SD) | 5.7 (2.5) | 5.4 (2.7) | − 0.29 (p = 0.17) | 5.3 (2.4) | 5.1 (2.7) | − 0.19 (p = 0.45) |
Mean change at 12 weeks from Baseline (SD) | − 1.1 (2.1) | − 1.4 (2.8) | − 0.26 95% CI (− 0.61, 0.09) | − 1.4 (2.2) | − 1.7 (2.2) | − 0.23 95% CI (− 0.65, 0.18) |
Responders (> 30% improvement) | 87 (30.5%) | 104 (34.8%) | 4.3% 95% CI (− 3.3%, 11.9%) | 73 (36.3%) | 83 (39.2%) | 2.8% 95% CI (− 6.5%, 12.2%) |
24 weeks | ||||||
N | 286 | 294 | N/A | 196 | 204 | N/A |
Mean (SD) | 6.0 (2.6) | 5.8 (2.6) | − 0.18 (p = 0.72) | 5.7 (2.5) | 5.5 (2.5) | − 0.17 (p = 0.73) |
Mean change at 24 weeks from baseline (SD) | − 0.8 (2.3) | − 1.1 (2.2) | − 0.23 95% CI (− 0.59, 0.13) | − 1.0 (2.3) | − 1.2 (2.3) | − 0.17 95% CI (− 0.62, 0.25) |
Responders (> 30% improvement) | 65 (22.8%) | 74 (25.4%)* | 2.6% 95% CI (− 4.4%, 9.6%) | 48 (24.5%) | 56 (27.7%) | 3.2% 95% CI (− 5.4%, 11.9%) |
PROMIS: Physical health | ||||||
Baseline | ||||||
N | 385 | 387 | N/A | 217 | 228 | N/A |
Mean (SD) | 34.8 (7.2) | 34.8 (7.7) | 0.05 (p = 0.92) | 35.3 (7.1) | 35.2 (7.6) | − 0.04 (p = 0.96) |
12 Weeks | ||||||
N | 295 | 308 | N/A | 207 | 219 | N/A |
Mean (SD) | 38.5 (8.4) | 38.7 (8.3) | 0.21 (p = 0.76) | 39.4 (8.3) | 39.6 (8.1) | 0.22 (p = 0.78) |
Mean change at 12 weeks from baseline (SD) | 3.6 (7.3) | 3.6 (6.5) | 0.08 95% CI (− 0.97, 1.13) | 3.8 (7.1) | 4.2 (6.4) | 0.36 95% CI (− 0.87, 1.59) |
Responders (≥ 2-point improvement) | 173 (59.5%) | 193 (63.1%) | 3.6% 95% CI (− 4.2%, 11.4%) | 125 (61.3%) | 147 (67.7%) | 6.5% 95% CI (− 2.7%, 15.6%) |
24 weeks | ||||||
N | 287 | 297 | N/A | 196 | 206 | N/A |
Mean (SD) | 37.2 (8.7) | 37.8 (8.5) | 0.60 (p = 0.4) | 38.2 (8.7) | 38.7 (8.1) | 0.54 (p = 0.52) |
Mean change at 24 weeks from baseline (SD) | 2.4 (7.3) | 2.7 (6.4) | 0.38 95% CI (− 0.69, 1.45) | 2.5 (7.1) | 3.1 (6.1) | 0.64 95% CI (− 0.61, 1.90) |
Responders (≥ 2-point improvement) | 142 (50.2%) | 164 (55.4%) | 5.2% 95% CI (− 2.9%, 13.4%) | 96 (49.7%) | 121 (59.0%) | 9.3% 95% CI (− 0.5%, 19.0%) |
PROMIS: Mental health | ||||||
Baseline | ||||||
N | 385 | 384 | N/A | 219 | 226 | N/A |
Mean (SD) | 42.8 (9.8) | 42.4 (9.6) | − 0.40 (p = 0.57) | 43.6 (9.6) | 43.5 (9.7) | − 0.09 (p = 0.92) |
12 weeks | ||||||
N | 291 | 308 | N/A | 204 | 218 | N/A |
Mean (SD) | 43.8 (9.4) | 44.5 (9.6) | 0.76 (p = 0.33) | 44.4 (9.2) | 45.2 (9.3) | 0.78 (p = 0.39) |
Mean change at 12 weeks from baseline (SD) | 1.1 (8.4) | 1.5 (7.1) | 0.48 95% CI (− 0.65, 1.61) | 0.8 (8.0) | 1.4 (6.6) | 0.66 95% CI (− 0.61, 1.93) |
Responders (≥ 5-point improvement) | 75 (26.0%) | 84 (27.6%) | 1.6% 95% CI (− 5.6%, 8.7%) | 48 (23.6%) | 57 (26.5%) | 2.9% 95% CI (− 5.4%, 11.2%) |
24 weeks | ||||||
N | 288 | 297 | N/A | 198 | 206 | N/A |
Mean (SD) | 43.3 (9.9) | 44.1 (9.4) | 0.78 (p = 0.33) | 44.1 (9.7) | 45 (9.0) | 0.88 (p = 0.35) |
Mean change at 24 weeks from baseline (SD) | 0.8 (7.5) | 1.3 (6.9) | 0.52 95% CI (− 0.56, 1.61) | 0.4 (7.2) | 1.4 (6.6) | 0.94 95% CI (− 0.30, 2.18) |
Responders (≥ 5-point improvement) | 72 (25.3%) | 86 (29.2%) | 3.9% 95% CI (− 3.4%, 11.1%) | 45 (22.8%) | 59 (28.9%) | 6.1% 95% CI (− 2.5%, 14.6%) |