Table 3.
Treatment effects from repeated-measures ANCOVA (ITT sample*).
| Outcome/Group/Time-point | Estimate (SE) | 95% CIs | P |
|---|---|---|---|
| Disability (ODI) posttreatment | |||
| DTxP vs Sham placebo | −4.86 (4.48) | −13.98 to 4.26 | 0.29 |
| DTxP vs Standard care | −5.25 (4.67) | −14.77 to 4.27 | 0.27 |
| Sham placebo vs Standard care | −0.39 (4.69) | −9.95 to 9.17 | 0.93 |
| Disability (ODI) end of the study | |||
| DTxP vs Sham placebo | 1.88 (4.16) | −6.76 to 10.51 | 0.66 |
| Pain interference (PROMIS 6b) posttreatment | |||
| DTxP vs Sham placebo | −3.98 (1.96) | −7.99 to 0.03 | 0.05 |
| DTxP vs Standard care | −3.20 (2.13) | −7.55 to 1.16 | 0.14 |
| Sham placebo vs Standard care | 0.79 (2.07) | −3.45 to 5.02 | 0.71 |
| Fear of movement (TSK) posttreatment | |||
| DTxP vs sham placebo | −4.91 (2.30) | −9.57 to −0.25 | 0.04 |
| DTxP vs standard care | −6.16 (2.35) | −10.95 to −1.38 | 0.01 |
| Sham placebo vs standard care | −1.25 (2.36) | −6.04 to 3.53 | 0.60 |
| Fear of movement (TSK) end of the study | |||
| DTxP vs Sham placebo | −1.74 (2.68) | −7.28 to 3.80 | 0.52 |
| Average Pain intensity (NRS) posttreatment | |||
| DTxP vs sham placebo | −0.73 (0.82) | −2.40 to 0.94 | 0.38 |
| DTxP vs standard care | −0.42 (0.90) | −2.25 to 1.41 | 0.64 |
| Sham placebo vs Standard care | 0.31 (0.86) | −1.44 to 2.06 | 0.72 |
| Pain intensity (NRS) end of the study | |||
| DTxP vs sham placebo | 0.32 (0.82) | −1.44 to 2.08 | 0.70 |
| Maximum pain intensity (NRS) posttreatment | |||
| DTxP vs sham placebo | −0.35 (1.04) | −2.47 to 1.78 | 0.74 |
| DTxP vs standard care | −0.87 (1.14) | −3.20 to 1.47 | 0.45 |
| Sham placebo vs standard care | −0.52 (1.10) | −2.75 to 1.71 | 0.64 |
| Pain intensity (NRS) end of the study | |||
| DTxP vs sham placebo | 0.89 (0.88) | −0.98 to 2.76 | 0.33 |
| Minimum pain intensity (NRS) post-treatment | |||
| DTxP vs sham placebo | −0.88 (0.84) | −2.58 to 0.83 | 0.30 |
| DTxP vs standard care | −0.24 (0.92) | −2.11 to 1.63 | 0.79 |
| Sham placebo vs standard care | −0.63 (0.88) | −1.16 to 2.43 | 0.48 |
| Pain intensity (NRS) end of the study | |||
| DTxP vs sham placebo | 0.28 (0.81) | −1.46 to 2.03 | 0.73 |
| Pain intensity (PROMIS 3a) posttreatment | |||
| DTxP vs sham placebo | −2.48 (2.88) | −8.35 to 3.40 | 0.40 |
| DTxP vs standard care | −2.07 (3.09) | −8.39 to 4.24 | 0.51 |
| Sham placebo vs standard care | 0.41 (3.01) | −5.75 to 6.56 | 0.89 |
| PGIC posttreatment | |||
| DTxP vs sham placebo | −1.12 (0.54) | −2.22 to −0.03 | 0.04 |
| DTxP vs standard care | −1.26 (0.57) | −2.43 to −0.09 | 0.04 |
| Sham placebo vs standard care | −0.13 (0.56) | −1.28 to 1.01 | 0.81 |
| PGIC end of the study | |||
| DTxP vs sham placebo | −0.01 (0.62) | −1.29 to 1.27 | 0.98 |
*
DTxP, n = 14; sham placebo, n = 17; standard care, n = 11.
CI, confidence intervals; DTXP, digital treatment for pain; NRS, numerical rating scale; ODI, Oswestry Disability Index; PGIC, patient global impression of change; PROMIS, Patient-Reported Outcomes Information System; TSK, Tampa Scale for Kinesiophobia.