TABLE 4.
Results of pain and function outcome measures.
| Domains and variables | Active group (n = 11) |
Sham group (n = 10) |
||||||||||
| Baseline (T0) |
Post-intervention (T1) |
Follow-up (T2) |
T0-T1 | T0-T2 | T1-T2 | Baseline (T0) |
Post-intervention (T1) |
Follow-up (T2) |
T0-T1 | T0-T2 | T1-T2 | |
| Pain severity and interference -BPI, M (SD), 95% CI and 75% CI | ||||||||||||
| Pain severity sub-score (24 h items) | 3.4 (1.8) [2.2,4.6] [2.7, 4.0] |
2.5 (1.7) [1.3, 3.7] [1.9, 3.1] |
2.4 (2.1) [1.1, 3.8] [1.7, 3.2] |
0.89 (1.7) [−0.27, 2.0] [0.25, 1.5] |
0.95 (1.5) [−0.064, 2.0] [0.40, 1.5] |
0.07 (1.1) [−0.69, 0.83] [−0.35, 0.49] |
3.4 (1.3) [2.5, 4.4] [2.9, 3.9] |
2.5 (1.7) [1.2, 3.7] [1.8, 3.1] |
2.6 (1.9) [1.2, 3.9] [1.8, 3.3] |
0.98 (1.1) [0.22, 1.7] [0.56, 1.4] |
0.85 (0.86) [0.24, 1.5] [0.52, 1.2] |
−0.13 (0.98) [−0.83, 0.58] [−0.51, 0.26] |
| Pain interference sub-score | 2.4 (1.4) [1.5, 3.4] [1.9, 2.9] |
1.7 (1.6) [0.63, 2.7] [1.1, 2.3] |
Not applicable (NA) |
0.75 (2.3) [−0.82, 2.3] [−0.11, 1.6] |
NA | NA | 2.9 (2.5) [1.1, 4.7] [1.9, 3.9] |
2.0 (1.9) [0.65, 3.4] [1.3, 2.8] |
NA | 0.89 (2.1) [−0.60, 2.4] [0.076, 1.7] |
NA | NA |
| Worst pain in the past 24 h | 5.3 (2.5) [3.6, 6.9] [4.4, 6.2] |
3.7 (2.1) [2.3, 5.1] [3, 4.5] |
3.8 (3.0) [1.9, 5.8] [2.8, 4.9] |
1.5 (2.1) [0.16, 2.9] [0.78, 2.3] |
1.5 (2.6) [−0.28, 3.2] [0.50, 2.4] |
−0.091 (2.3) [−1.6, 1.5] [−0.94, 0.76] |
5.7 (1.9) [4.3, 7.1] [5, 6.4] |
4.1 (2.5) [2.3, 5.9] [3.1, 5.1] |
4.0 (2.6) [2.2, 5.8] [3, 5] |
1.6 (1.8) [0.33, 2.9] [0.91, 2.3] |
1.7 (1.5) [0.63, 2.8] [1.1, 2.3] |
0.10 (1.7) [−1.1, 1.3] [−0.57, 0.77] |
| Worst pain in the past 4 weeks | 6.3 (2.7) [4.4, 8.1] [5.3, 7.3] |
4.9 (2.6) [3.1, 6.7] [3.9, 5.9] |
NA | 1.4 (2.3) [−0.21, 2.9] [0.50, 2.2] |
NA | NA | 6.2 (1.3) [5.3, 7.1] 5.7, 6.7] |
5.8 (2.5) [4.0, 7.6] [4.8, 6.8] |
NA | 0.40 (2.2) [−1.2, 2.0] [−0.44, 1.2] |
NA | NA |
| Least pain in the past 24 weeks | 1.9 (2.2) [0.45, 3.4] [1.1, 2.7] |
1.7 (1.6) [0.64, 2.8] [1.1, 2.3] |
1.4 (1.9) [0.11, 2.6] [0.68, 2] |
0.18 (2) [−1.2, 1.5] [−0.55, 0.91] |
0.55 (1.6) [−0.55, 1.6] [−0.06, 1.1] |
0.36 (1.2) [−0.45, 1.2] [−0.08, 0.81] |
2.0 (1.8) [0.69, 3.3] [1.3, 2.7] |
1.1 (1.3) [0.18, 2.0] [0.60, 1.6] |
1.1 (1.5) [0.01, 2.2] [0.51, 1.7] |
0.90 (1.1) [0.11, 1.7] [0.47, 1.3] |
0.90 (1.4) [−0.14, 1.9] [0.34, 1.5] |
0.0 (0.47) [−0.34, 0.34] [−0.18, 0.18] |
| Least pain in the past 4 weeks | 2.1 (2.6) [0.33, 3.9] [1.1, 3.1] |
1.2 (1.4) [0.24, 2.1] [0.67, 1.7] |
NA | 0.91 (1.9) [−0.38, 2.2] [0.20, 1.6] |
NA | NA | 1.5 (2.2) [−0.09, 3.1] [0.64, 2.4] |
1.6 (2.0) [0.20, 3.0] [0.84, 2.4] |
NA | −0.10 (0.88) [−0.73, 0.53] [−0.44, 0.24] |
NA | NA |
| Average pain in the past 24 h | 3.6 (2.0) [2.3, 5.0] [2.9, 4.4] |
2.4 (1.9) [1.1, 3.6] [1.7, 3.1] |
2.5 (2.1) [1.1, 4.0] [1.8, 3.3] |
1.3 (1.7) [0.11, 2.4] [0.63, 1.9] |
1.1 (1.4) [0.17, 2.0] [0.58, 1.6] |
−0.18 (0.87) [−0.77, 0.41] [−0.50, 0.14] |
3.6 (1.4) [2.6, 4.6] [3, 4.2] |
2.8 (2.0) [1.3, 4.3] [2, 3.6] |
2.9 (2.0) [1.5, 4.3] [2.1, 3.7] |
0.80 (1.9) [−0.54, 2.1] [0.07, 1.5] |
0.70 (1.5) [−0.37, 1.8] [0.12, 1.3] |
−0.10 (0.99) [−0.81, 0.61] [−0.49, 0.29] |
| Average pain in the past 4 weeks | 4.0 (2.0) [2.6, 5.4] [3.2, 4.8] |
2.6 (2.2) [1.2, 4.1] [1.8, 3.4] |
NA | 1.4 (1.6) [0.31, 2.4] [0.79, 1.9] |
NA | NA | 3.9 (1.7) [2.7, 5.1] [3.3, 4.5] |
3.0 (1.9) [1.7, 4.3] [2.3, 3.7] |
NA | 0.90 (1.5) [−0.19, 2.0] [0.31, 1.5] |
NA | NA |
| Current pain (at the time of assessment) | 2.7 (1.8) [1.5, 3.9] [2.1, 3.4] |
2.2 (2.0) [0.84, 3.5] [1.4, 2.9] |
1.8 (2.0) [0.62, 3.4] [1.2, 2.8] |
0.55 (2) [−0.78, 1.9] [−0.18, 1.3] |
0.73 (2) [−0.62, 2.1] [−0.01, 1.5] |
0.18 (1.3) [−0.66, 1.0] [−0.28, 0.64] |
2.4 (1.5) [1.3, 3.5] [1.8, 3] |
1.8 (1.8) [0.50, 3.1] [1.1, 2.5] |
2.3 (2.4) [0.58, 4.0] [1.4, 3.2] |
0.60 (1.9) [−0.76, 2.0] [−0.14, 1.3] |
0.10 (1.8) [−1.2, 1.4] [−0.60, 80] |
−0.50 (2.5) [−2.3, 1.3] [−1.5, 0.47] |
| Pain unpleasantness, M (SD) | 6.5 (2.8) [4.7, 8.4] [5.5, 7.6] |
3.9 (3.0) [1.9, 5.9] [2.8, 5] |
3.6 (2.9) [1.7, 5.6] [2.6, 4.7] |
2.6 (3.7) [0.17, 5.1] [1.3, 4] |
2.9 (2.9) [0.95, 4.9] [1.8, 4] |
0.27 (2.1) [−1.1, 1.7] [−0.48, 1] |
7.1 (3.4) [4.7, 9.5] [5.8, 8.4] |
4.3 (2.5) [2.5, 6.1] [3.3, 5.3] |
5.3 (3.3) [3.0, 7.6] [4, 6.6] |
2.8 (3) [0.62, 5.0] [1.6, 4] |
1.8 (3.6) [−0.81, 4.4] [0.38, 3.2] |
−1.0 (2.2) [−2.6, 0.58] [−1.9, −0.14] |
| Pain bothersomeness, n (%), No bothersome | 9 (81.8%) | 10 (90.1%) | 10 (90.1%) | NA | NA | NA | 7 (70%) | 9 (90%) | 10 (100%) | NA | NA | NA |
| Physical function, physical activity, and participation-KOOS, M (SD) and 95% CI— (higher the score, higher function) | ||||||||||||
| KOOS pain | 56 (14) [47, 66] [51, 62] |
59 (18) [47, 72] [53, 66] |
NA | 3.1 (17) [−8.3, 14] [−3.2, 9.3] |
NA | NA | 51 (15) [40, 62] [45, 57] |
60 (16) [49, 72] [54, 67] |
NA | 9.2 (12) [0.51, 18] [4.5, 14] |
NA | NA |
| KOOS symptom | 40 (13) [31, 49] [35, 45] |
44 (10) [37, 51] [40, 47] |
NA | 3.2 (9.3) [−3.1, 9.5] [−0.23, 6.6] |
NA | NA | 47 (13) [38, 57] [42, 53] |
51 (12) [42, 59] [46, 55] |
NA | 3.3 (14) [−6.8, 13] [−2.2, 8.8] |
NA | NA |
| KOOS ADL | 68 (13) [59, 77] [63, 73] |
68 (16) [57, 79] [62, 74] |
NA | −0.36 (10) [−7.2, 6.5] [−4.1, 3.4] |
NA | NA | 68 (17) [56, 80] [62, 75] |
64 (19) [50, 78] [57, 71] |
NA | −4.1 (17) [16, 8.3] [−11, 2.6] |
NA | NA |
| KOOS sports/recreation | 34 (27) [14, 53] [23, 44] |
53 (28) [33, 73] [42, 64] |
NA | 18 (33) [−4.1, 40] [5.8, 30] |
NA | NA | 45 (28) [25, 65] [34, 56] |
44 (20) [29, 58] [36, 51] |
NA | −1.5 (26) [−20, 17] [−12, 8.8] |
NA | NA |
| KOOS QOL | 42 (15) [32, 52] [37, 48] |
49 (12) [41, 57] [44, 54] |
NA | 6.8 (12) [−1.5, 15] [2.2, 11] |
NA | NA | 45 (11) [37, 53] [41, 49] |
46 (10) [39, 54] [42, 50] |
NA | 1.3 (8.9) [−5.0, 7.6] [−2.1, 4.7] |
NA | NA |
| KOOS aggregate | 47 (12) [39, 56] [43, 52] |
54 (15) [44, 64] [48, 59] |
NA | 6.2 (13) [−2.6, 15] [1.4, 11] |
NA | NA | 51 (12) [43, 60] [47, 56] |
53 (11) [45, 61] [49, 57] |
NA | 1.6 (12) [−6.8, 10] [−3, 6.2] |
NA | NA |