Table 2.
Outcome measures (intention-to-treat [ITT] sample).
| DTxP (n = 14; mean (SD)) | Sham placebo (n = 17; mean (SD)) | Standard care (n = 11; mean (SD)) | |
|---|---|---|---|
| Oswestry Disability Index | |||
| Screening | 36.0 (7.6) | 37.2 (9.4) | 36.2 (7.6) |
| Day 1 | 34.8 (11.0) | 38.2 (9.4) | 33.8 (7.5) |
| Posttreatment | 28.8 (15.6)* | 38.5 (16.2) | 32.8 (8.6) |
| End of the study | 29.1 (17.2)* | 31.3 (12.8)** | — |
| Pain interference (PROMIS 6b) | |||
| Screening | 64.5 (3.7) | 63.1 (3.4) | 63.1 (2.5) |
| Day 1 | 63.6 (2.3) | 63.2 (2.9) | 62.1 (3.5) |
| Posttreatment | 59.0 (6.6)** | 62.6 (5.3) | 60.9 (3.8) |
| Tampa Scale for Kinesiophobia | |||
| Screening | 41.9 (4.4) | 43.2 (6.0) | 42.5 (5.4) |
| Day 1 | 39.5 (4.4) | 44.3 (5.9) | 40.3 (4.6) |
| Posttreatment | 33.7 (7.4)*** | 43.1 (8.5) | 39.8 (7.1) |
| End of the study | 33.7 (9.2)** | 40.2 (7.5)* | — |
| Average pain (NRS) | |||
| Screening | 6.0 (1.4) | 6.1 (1.4) | 5.7 (1.6) |
| Day 1 | 5.7 (1.4) | 5.6 (1.9) | 5.4 (2.0) |
| Posttreatment | 4.1 (1.7)* | 4.8 (2.3) | 4.4 (2.4) |
| End of the study | 4.4 (1.9) | 4.0 (1.8)* | — |
| Maximum pain (NRS) | |||
| Screening | 8.2 (0.9) | 8.3 (0.9) | 8.5 (0.9) |
| Day 1 | 7.5 (1.3) | 7.5 (1.8) | 7.4 (1.6) |
| Posttreatment | 6.0 (2.4) | 6.9 (2.5) | 6.9 (2.5) |
| End of the study | 6.8 (2.1) | 6.3 (2.7)* | — |
| Minimum pain (NRS) | |||
| Screening | 3.5 (2.1) | 4.2 (2.0) | 4.5 (1.9) |
| Day 1 | 3.8 (1.7) | 4.4 (2.0) | 3.6 (2.7) |
| Posttreatment | 2.6 (1.6) | 3.5 (2.3) | 2.8 (2.5) |
| End of the study | 2.7 (1.7) | 2.6 (1.7)* | — |
| Pain intensity (PROMIS 3a) | |||
| Screening | 66.5 (4.1) | 65.1 (5.4) | 63.0 (5.5) |
| Day 1 | 66.1 (5.6) | 64.5 (5.2) | 64.5 (5.9) |
| Posttreatment | 60.0 (7.5)** | 61.9 (8.3) | 61.0 (5.9) |
| EQ-5D | |||
| Mobility | |||
| Day 1 | 2.2 (0.7) | 2.5 (0.9) | 2.1 (0.5) |
| Posttreatment | 2.0 (1.0) | 2.3 (0.9) | 2.1 (0.6) |
| Usual activities | |||
| Day 1 | 2.6 (0.8) | 2.2 (0.6) | 1.9 (0.5) |
| Posttreatment | 2.2 (1.2) | 2.2 (0.9) | 1.8 (0.6) |
| Anxiety/depression | |||
| Day 1 | 1.7 (0.9) | 1.6 (0.7) | 1.2 (0.4) |
| Posttreatment | 2.0 (1.2) | 1.8 (0.8) | 1.2 (0.4) |
| Pain/discomfort | |||
| Day 1 | 3.2 (0.4) | 2.7 (0.7) | 2.8 (0.8) |
| Posttreatment | 2.5 (0.8) | 2.6 (0.8) | 2.6 (0.7) |
| Self-care | |||
| Day 1 | 1.5 (0.8) | 1.6 (0.6) | 1.8 (0.6) |
| Posttreatment | 1.3 (0.7) | 1.7 (0.6) | 1.5 (0.7) |
| Health state (0-100) | |||
| Day 1 | 47.7 (16.8) | 63.8 (15.1) | 55.7 (19.6) |
| Posttreatment | 66.1 (22.2) | 58.1 (26.8) | 62.0 (23.9) |
| PGIC | |||
| Posttreatment | 2.7 (1.4)*** | 3.8 (1.5)*** | 3.9 (0.7)*** |
| End of the study | 3.0 (1.5)*** | 3.0 (1.5)*** | — |
Significance levels are compared with day 1, *<0.05, **<0.01, ***<0.001.
M, mean; NRS, numerical rating scale; PGIC, patient global impression of change; PROMIS, Patient-Reported outcomes Information System.