Table 4.
Baseline to post-intervention and 6-month change in outcomes: mean ± standard deviation or N(%) (p-value)
| PENS Only | PENS+CGAE | Sham Only | Sham+CGAE | |
|---|---|---|---|---|
| Baseline to Post-Intervention Change in: | ||||
| Primary Outcomes: Pain and Function | ||||
| MPQ Total | −2.9±9.2[.40] | −4.1±8.2[.56] | −2.3±6.3[.31] | −3.1±7.9[.42] |
| (0.0344) | (0.0017) | (0.0145) | (0.0123) | |
| Roland questionnaire | −2.6±4.5[.56] | −2.6±4.6[.56] | −2.7±3.8[.59] | −3.0±4.7[.65] |
| (0.0002) | (0.0005) | (<.0001) | (0.0001) | |
| Secondary Outcomes: Pain | ||||
| Average pain past week* | −0.7±1.1[.89] | −0.7±0.9[.86] | −0.6±0.7[.72] | −0.6±1.2[.77] |
| (<.0001) | (<.0001) | (<.0001) | (0.0012) | |
| Strongest pain past week* | −0.7±1.3[.75] | −0.7±1.4[.74] | −0.6±1.1[.72] | −0.5±1.1[.57] |
| (0.0008) | (0.0023) | (0.0002) | (0.0054) | |
| Secondary Outcomes: Psychological | ||||
| GDS total score | 0.3±3.2[.06] | −0.4±2.6[.08] | −0.2±2.8[.05] | −0.3±3.2[.07] |
| (0.5901) | (0.3709) | (0.6034) | (0.5155) | |
| CSQ catastrophizing score | −0.3±0.9[.27] | 0.0±0.9[.04] | 0.1±1.0[.05] | −0.1±0.8[.13] |
| (0.0266) | (0.7518) | (0.7269) | (0.2430) | |
| FAB physical activities | −0.1±1.3[.08] | −0.6±1.4[.41] | 0.2±1.8[.11] | −1.0±1.8[.64] |
| (0.5382) | (0.0032) | (0.5174) | (0.0005) | |
| Chronic pain self-efficacy | 3.2±16.7[.19] | 5.7±13.4[.33] | 4.9±16.1[.28] | 7.9±15.5[.45] |
| (0.1902) | (0.0070) | (0.0425) | (0.0016) | |
| SF-36 composite mental health | 1.5±12.0[.11] | −0.3±11.4[.02] | −0.1±10.8[.01] | 2.8±13.7[.20] |
| (0.3863) | (0.8421) | (0.9436) | (0.1847) | |
| Secondary Outcomes: Physical Function | ||||
| Usual pace gait speed | 0.05±0.07[.50] | 0.07±0.07[.70] | 0.06±0.08[.60] | 0.08±0.08[.80] |
| (<.0001) | (<.0001) | (<.0001) | (<.0001) | |
| Chair rise time | −0.9±2.4[.31] | −0.7±1.1[.25] | −0.4±1.3[.24] | −1.5±3.7[.55] |
| (0.0232) | (0.0001) | (0.1424) | (0.0122) | |
| Stair climb time | −1.3±6.2[.11] | −0.9±4.9[.08] | −1.3±5.9[.12] | −2.2±6.0[.19] |
| (0.1533) | (0.2541) | (0.1199) | (0.0252) | |
| Secondary Outcomes: Other | ||||
| Pittsburgh sleep score | −0.2±2.0[.06] | 0.02±2.3[.01] | 0.0±2.7[.00] | −0.7±2.3[.22] |
| (0.5070) | (0.9486) | (1.0000) | (0.0445) | |
| SF-36 composite physical health | −1.1±20.7[.04] | 3.9±25.8[.14] | 5.9±23.8[.21] | 6.9±22.7[.25] |
| (0.7257) | (0.3103) | (0.0909) | (0.0489) | |
| Global change in condition | ||||
| Deterioration | 1 (2.1) | 1 (2.2) | 0 (0.0) | 0 (0.0) |
| No improvement | 12 (25.5) | 8 (17.8) | 8 (17.7) | 6 (13.6) |
| Minor improvement | 7 (14.9) | 10 (22.2) | 13 (27.1) | 9 (20.5) |
| Moderate improvement | 13 (27.7) | 15 (33.3) | 16 (33.3) | 15 (34.1) |
| Major improvement | 14 (29.8) | 11 (24.4) | 11 (22.9) | 14 (31.8) |
| Baseline to 6-month Change in: | ||||
| Primary Outcomes: Pain and Function | ||||
| MPQ Total | −3.4±7.4[.47] | −3.8±8.9[.51] | −3.3±7.4[.45] | −3.1±7.1[.41] |
| (0.0041) | (0.0075) | (0.0044) | (0.0093) | |
| Roland questionnaire | −2.1±4.2[.44] | −2.1±4.3[.45] | −3.0±4.7[.64] | −2.8±5.3[.60] |
| (0.0025) | (0.0027) | (0.0001) | (0.0022) | |
| Secondary Outcomes: Pain | ||||
| Average pain past week* | −0.5±1.1[.57] | −0.6±1.1[.73] | −0.6±0.8 | −0.5±1.1 |
| (0.0094) | (0.0004) | (<.0001)[.70] | (0.0040) [.64] | |
| Strongest pain past week* | −0.4±1.4[.48] | −0.8±1.4[.95] | −0.6±1.1[.68] | −0.6±1.2[.68] |
| (0.0511) | (0.0002) | (0.0006) | (0.0029) | |
| Secondary Outcomes: Psychological | ||||
| GDS total score | 0.5±3.0[.12] | −0.1±2.2[.02] | −0.4±2.7[.09] | −0.1±3.0[.01] |
| (0.2431) | (0.7861) | (0.3317) | (0.9155) | |
| CSQ catastrophizing score | −0.1±1.0[.13] | 0.0±0.8[.01] | 0.1±0.8[.07] | −0.1±0.8[.13] |
| (0.3926) | (0.9277) | (0.5553) | (0.2723) | |
| FAB physical activities | 0.1±1.6[.05] | −0.6±1.5[.35] | −0.4±1.7[.27] | −0.9±1.5[.56] |
| (0.7615) | (0.0157) | (0.0931) | (0.0007) | |
| Chronic pain self-efficacy | 1.4±15.2[.08] | 5.7±17.6[.33] | 4.0±16.1[.23] | 4.1±16.7[.24] |
| (0.5556) | (0.0388) | (0.1019) | (0.1271) | |
| SF-36 composite mental health | −1.8±15.5[.13] | −0.2±13.7[.01] | 1.2±11.3[.09] | 1.5±13.9[.11] |
| (0.4378) | (0.9417) | (0.4895) | (0.5117) | |
| Secondary Outcomes: Physical Function | ||||
| Usual pace gait speed | 0.04±0.07[.40] | 0.06±0.07[.60] | 0.05±0.09[.50] | 0.05±0.08[.50] |
| (0.0008) | (<.0001) | (0.0016) | (0.0002) | |
| Chair rise time | −0.7±2.5[.27] | −0.8±1.2[.28] | −1.4±2.7[.53] | −1.3±4.0[.49] |
| (0.0660) | (0.0001) | (0.0017) | (0.0512) | |
| Stair climb time | 0.8±7.5[.07] | −0.4±5.4[.03] | −1.1±6.7[.10] | −2.1±6.5[.19] |
| (0.4855) | (0.6448) | (0.2910) | (0.0551) | |
| Secondary Outcomes: Other | ||||
| Pittsburgh sleep score | −0.4±2.7[.13] | 0.1±2.7[.03] | −0.4±2.6[.12] | −0.6±2.9[.18] |
| (0.3169) | (0.8271) | (0.3327) | (0.2333) | |
| SF-36 composite physical health | −5.9±21.0[.21] | 4.4±25.3[.16] | 5.1±24.7[.18] | 8.5±27.4[.30] |
| (0.0744) | (0.2582) | (0.1760) | (0.0572) | |
| Global change in condition | ||||
| Deterioration | 5 (11.6) | 2 (4.6) | 1 (2.2) | 2 (5.0) |
| No improvement | 15 (34.9) | 10 (22.7) | 18 (40.0) | 7 (17.5) |
| Minor improvement | 6 (14.0) | 8 (18.2) | 6 (13.3) | 11 (27.5) |
| Moderate improvement | 10 (23.3) | 15 (34.1) | 13 (28.9) | 9 (22.5) |
| Major improvement | 7 (16.3) | 9 (20.5) | 7 (15.6) | 11 (27.5) |
*
Assessed with pain thermometer
BMI = body mass index
MPQ = McGill Pain Questionnaire (short form)
GDS = Geriatric Depression Screen
CSQ = Coping Strategies Questionnaire
FAB = fear avoidance beliefs
SF-36 = Medical Outcomes Study 36 Item Short Form Health Survey