Table 3. BPI Scores, Functional Impairment, and Quality of Life at Pre-Session 1 (Baseline) Compared to those at Follow-Up in the NT, PT-TENS and Cross-over-to-NT (XO) Groups.
| A. Study Onea,b | |||||
|---|---|---|---|---|---|
| Measurement | Mean Score Pre-Session1 (SD) | Mean Score at Follow-Up (SD) | Mean of Score Difference (95% CI) | One-Sample t test p-value | Wilcoxon Signed-rank testp-value |
| BPI “at-its-worst” | |||||
| NT (n = 22) | 7.7 (0.9) | 0.8 (1.5) | −6.9 (−7.7–−6.1) | <0.0001 | <0.0001 |
| PT-TENS (n = 8) | 8.1 (1.1) | 8.2 (1.5) | 0.1 (−1.2–1.5) | 0.84 | 1 |
| XO (n = 7) | 8.1 (1.6) | 1.3 (1.1) | −6.9 (−8.5–−5.2) | 0.00059 | 0.022 |
| BPI “average” | |||||
| NT (n = 22) | 5.2 (1.5) | 0.5 (1.2) | −4.6 (−5.4–−3.9) | <0.0001 | <0.0001 |
| PT-TENS (n = 8) | 5.9 (1.5) | 6.6 (1.7) | 0.7 (−0.4–1.8) | 0.19 | 0.20 |
| XO (n = 7) | 6.4 (1.7) | 0.6 (0.7) | −5.8 (−7.2–−4.3) | 0.00069 | 0.022 |
| BPI “right-now” | |||||
| NT (n = 22) | 5.2 (2.3) | 0.6 (1.3) | −4.7 (−5.8–−3.5) | <0.0001 | <0.0001 |
| PT-TENS (n = 8) | 5.6 (2.2) | 6.8 (2) | 1.2 (0.1–2.3) | 0.037 | 0.58 |
| XO (n = 7) | 6.6 (2.1) | 0.6 (0.5) | −6 (−7.7–−4.3) | 0.00013 | 0.022 |
| Functional Impairment | |||||
| NT (n = 22) | 10.2 (6.9) | 2.3 (3.3) | −7.9 (−10.8–−5) | <0.0001 | <0.0001 |
| PT-TENS (n = 8) | 5.8 (8) | 7 (4.9) | 1.2 (−3.5–6) | 0.55 | 0.59 |
| XO (n = 7) | 6.7 (5.2) | 1.9 (2.9) | −4.9 (−7.5–−2.2) | 0.0045 | 0.022 |
| Quality of Life- Accumulative BPI “interference with functions” | |||||
| NT (n = 22) | 26.4 (16.6) | 3.4 (8) | −23 (−30.6–−15.4) | <0.0001 | <0.0001 |
| PT-TENS (n = 8) | 27.5 (13.3) | 27.9 (10.9) | 0.4 (−3.4–4.3) | 0.80 | 0.83 |
| XO (n = 7) | 29.1 (11.3) | 3.7 (5.6) | −25.4 (−36–−14.7) | 0.0011 | 0.015 |
| B. Study Two | |||||
| Measurement | Mean Score Pre-Session1 (SD) | Mean Score at Follow-1 (SD) | Mean of Score Difference (95% CI) | One-Sample t Test p-value | Wilcoxon Signed-rank testp-value |
| (a) Baseline vs. Follow-up 1 | |||||
| BPI “at-its-worst” | |||||
| NT(n = 20) | 6.5 (1.3) | 2.1 (2.0) | −4.5 (−5.6–−3.3) | <0.0001 | 0.0001 |
| PT-TENS (n = 18) | 6.4 (1.5) | 4.1 (1.8) | −1.8 (−3.0–−0.6) | 0.0058 | 0.0039 |
| BPI “average” | |||||
| NT (n = 20) | 5.0 (1.4) | 1.3 (1.4) | −3.6 (−4.5–−2.8) | <0.0001 | 0.00013 |
| PT-TENS (n = 18) | 4.3 (1.4) | 3.4 (1.5) | −0.9 (−1.8–−0.1) | 0.064 | 0.05 |
| BPI “right-now” | |||||
| NT (n = 20) | 4.3 (1.6) | 1.4 (1.5) | −3.0 (−4.0–−2.0) | <0.0001 | 0.00022 |
| PT-TENS (n = 18) | 3.3 (2.2) | 2.8 (1.5) | −0.4 (−1.5–0.6) | 0.37 | 0.28 |
| Functional Impairment | |||||
| NT | 14.1 (9.1) (n = 20) | 7.6 (8.4) (n = 16) | −8.1 (−11.5–−4.6) | 0.00018 | 0.001 |
| PT-TENS | 14.8 (6.6) (n = 18) | 11.6 (6.1) (n = 17) | −3.6 (−6.5–0.6) | 0.02 | 0.027 |
| Quality of Life- Accumulative BPI “interference with functions” | |||||
| NT (n = 20) | 36.3 (12.0) | 8.6 (10.9) | −27.8 (−34.3–−21.2) | <0.0001 | 0.0001 |
| PT-TENS (n = 18) | 33.4 (12.9) | 22.4 (10.9) | −11 (−18.4–−3.6) | 0.0058 | 0.01 |
| (b) Baseline vs. Follow-up 2 | |||||
| BPI “at-its-worst” | |||||
| NT(n = 20) | 6.5 (1.3) | 2.3 (1.8) | −4.45 (−5.6–−3.3) | <0.0001 | <0.0001 |
| PT-TENS (n = 18) | 6.4 (1.5) | 4.4 (2.2) | −2.3 (−3.7–−0.9) | 0.0040 | 0.0054 |
| BPI “average” | |||||
| NT (n = 20) | 5.0 (1.4) | 1.5 (1.5) | −3.5 (−4.4–−2.6) | <0.0001 | <0.0001 |
| PT-TENS (n = 18) | 4.3 (1.4) | 3.3 (1.9) | −0.9 (−2.0–−0.1) | 0.007 | 0.08 |
| BPI “right-now” | |||||
| NT (n = 20) | 4.3 (1.6) | 1.4 (1.4) | −3.0 (−3.9–−2.1) | <0.0001 | <0.0001 |
| PT-TENS (n = 18) | 3.3 (2.2) | 3.2 (1.8) | −0.06 (−1.0–0.9) | 0.9 | 0.9 |
| Functional Impairment | |||||
| NT | 14.1 (9.1) (n = 20) | 8.9 (8.2) (n = 15) | −6.9 (−10.3–−3.5) | 0.0007 | 0.0005 |
| PT-TENS | 14.8 (6.6) (n = 18) | 11.6 (5.8) (n = 16) | −3.6 (−6.9–−0.4) | 0.03 | 0.02 |
| Quality of Life- Accumulative BPI “interference with functions” | |||||
| NT (n = 20) | 36.3 (12.0) | 8.7 (9.0) | −27.7 (−33.9–−21.4) | <0.0001 | <0.0001 |
| PT-TENS (n = 18) | 33.4 (12.9) | 22.1 (13.5) | −11.3 (−18.4–−4.1) | 0.004 | 0.006 |
aAll results for the NT (test arm), PT-TENS (control arm) and XO (Crossover-to-NT) groups followed LOCF imputation. All patients except those undergoing no post-baseline observations were included.
bSD, standard deviation; CI, confidence interval.