Table 2.
Mean or median values (BCa 95% CI) of self-reported; sensory, autonomic, and motor; and neuropsychological secondary outcome measures at each time point (intention-to-treat analysis).
| Measure | Group | Time point | |||||
|---|---|---|---|---|---|---|---|
| RS1 | RS2 | RS3 | RS4 | LTFU1 | LTFU2 | ||
| Self-report questionnaires | |||||||
| Pain | |||||||
| Pain severity (Brief Pain Inventory[/10]) M | PA | 5.91 (5.17 to 6.58) | 6.02 (5.28 to 6.71) | 5.41 (4.50 to 6.26) | 5.43 (4.55 to 6.24) | 5.62 (4.69 to 6.48) | 5.59 (4.69 to 6.41) |
| Sham | 5.81 (5.02 to 6.50) | 5.95 (5.12 to 6.78) | 5.85 (5.04 to 6.65) | 5.84 (4.82 to 6.74) | 6.04 (5.12 to 6.80) | 5.95 (5.07 to 6.73) | |
| Pain interference (Brief Pain Inventory[/10]) Mdn | PA | 6.71 (6.29 to 6.71) | 6.43 (5.00 to 7.08) | 5.29 (3.57 to 6.43) | 5.57 (4.71 to 6.29) | 6.00 (5.22 to 6.14) | 5.86 (4.57 to 6.86) |
| Sham | 5.79 (5.00 to 7.14) | 5.86 (5.72 to 5.86) | 5.57 (5.43 to 5.57) | 5.64 (4.00 to 6.14) | 5.50 (3.71 to 6.57) | 5.72 (4.14 to 6.57) | |
| Neuropathic features of pain (Pain Detect Questionnaire[/38]) Mdn | PA | 26.00 (26.00 to 26.00) | 25.00 (20.00 to 26.00) | 24.00 (21.00 to 27.00) | 24.00 (20.00 to 26.00) | 26.00 (25.00 to 26.00) | 26.00 (21.46 to 28.00) |
| Sham | 23.50 (21.50 to 27.00) | 24.00 (23.00 to 24.00) | 23.50 (20.00 to 26.00) | 22.50 (17.06 to 26.00) | 23.00 (20.00 to 25.00) | 22.50 (18.00 to 26.00) | |
| Body representation | |||||||
| Bath CRPS Body Perception Disturbance Scale (/57) M | PA | 27.65 (22.83 to 32.34) | 27.78 (24.00 to 31.22) | 22.13 (17.88 to 26.44) | 24.39 (20.48 to 28.57) | 25.52 (21.78 to 29.30) | 24.57 (20.91 to 28.44) |
| Sham | 28.96 (23.96 to 33.76) | 27.73 (21.98 to 33.92) | 29.00 (23.00 to 35.36) | 26.81 (20.92 to 33.61) | 26.77 (21.48 to 32.68) | 27.65 (22.53 to 33.28) | |
| Emotional functioning | |||||||
| Fear of movement (Tampa Scale for Kinesiophobia[/68]) M | PA | 38.79 (35.45 to 41.95) | 38.52 (35.02 to 41.73) | 37.43 (34.26 to 40.50) | 37.91 (34.70 to 41.17) | 38.74 (35.33 to 41.95) | 40.05 (36.22 to 43.71) |
| Sham | 40.38 (37.17 to 43.35) | 39.73 (36.43 to 42.81) | 38.27 (34.90 to 41.45) | 37.42 (34.00 to 40.71) | 38.24 (34.97 to 41.56) | 37.27 (33.45 to 40.79) | |
| Mood disturbance (Profile of Mood States[/229]) M | PA | 94.81 (79.96 to 109.93) | 98.25 (82.66 to 113.93) | 86.52 (71.16 to 100.10) | 86.21 (73.85 to 99.00) | 88.80 (74.42 to 103.51) | 95.54 (73.56 to 117.95) |
| Sham | 84.22 (70.94 to 98.08) | 91.27 (76.05 to 106.01) | 83.21 (68.95 to 96.96) | 83.35 (68.76 to 97.56) | 82.42 (68.05 to 96.53) | 89.13 (70.81 to 106.31) | |
| Perceived improvement due to treatment | |||||||
| Patients' Global Impression of Change (/7) Mdn | PA | — | — | 2.00 (2.00 to 4.00) | 3.00 (3.00 to 3.00) | 2.00 (2.00 to 4.00) | 3.00 (2.00 to 3.00) |
| Sham | — | — | 3.00 (1.00 to 4.00) | 4.00 (3.00 to 4.00) | 2.00 (2.00 to 3.00) | 2.00 (1.00 to 4.00) | |
| Clinical assessments | |||||||
| Sensory functions | |||||||
| Mechanical detection threshold ratio Mdn | PA | −0.04 (−0.43 to 0.38) | −0.35 (−1.12 to 0.17) | −0.44 (−0.84 to −0.06) | −0.54 (−1.51 to −0.10) | — | — |
| Sham | −0.30 (−1.37 to 0.24) | −0.05 (−0.25 to 0.17) | −0.14 (−0.91 to 0.30) | −0.22 (−0.76 to 0.28) | — | — | |
| Mechanical pain threshold ratio Mdn | PA | 0.62 (0.06 to 0.69) | 0.50 (0.43 to 0.56) | 0.07 (−0.32 to 0.66) | 0.50 (0.06 to 0.69) | — | — |
| Sham | 0.57 (0.24 to 0.67) | 0.56 (0.38 to 0.73) | 0.50 (0.32 to 0.71) | 0.43 (0.24 to 0.78) | — | — | |
| Allodynia (/100) Mdn | PA | 14.00 (5.76 to 26.67) | 18.87 (4.67 to 30.89) | 16.90 (6.00 to 26.17) | 10.73 (2.87 to 18.26) | — | — |
| Sham | 20.50 (9.00 to 33.83) | 14.37 (6.47 to 25.03) | 13.87 (6.47 to 46.47) | 18.03 (7.33 to 33.33) | — | — | |
| Two-point discrimination threshold ratio Mdn | PA | −0.06 (−0.16 to 0.11) | 0.00 (−0.08 to 0.13) | −0.08 (−0.20 to 0.00) | −0.04 (−0.21 to 0.03) | — | — |
| Sham | 0.15 (−0.07 to 0.31) | −0.13 (−0.25 to 0.10) | −0.09 (−0.17 to 0.00) | 0.05 (−0.30 to 0.22) | — | — | |
| Autonomic functions | |||||||
| Absolute temperature difference (°C) Mdn | PA | 0.47 (0.27 to 1.40) | 0.30 (0.14 to 0.68) | 0.35 (0.20 to 0.73) | 0.50 (0.17 to 1.17) | — | — |
| Sham | 0.47 (0.30 to 0.78) | 0.82 (0.53 to 1.07) | 0.77 (0.43 to 1.05) | 0.67 (0.40 to 1.00) | — | — | |
| Oedema difference (cm) M | PA | −0.01 (−0.42 to 0.43) | −0.04 (−0.36 to 0.28) | −0.19 (−0.58 to 0.21) | −0.23 (−0.64 to 0.20) | — | — |
| Sham | −0.11 (−0.51 to 0.34) | −0.02 (−0.40 to 0.38) | −0.12 (−0.52 to 0.30) | 0.04 (−0.33 to 0.43) | — | — | |
| Motor functions | |||||||
| Grip strength ratio Mdn | PA | 0.35 (0.17 to 0.39) | 0.31 (0.25 to 0.44) | 0.35 (0.30 to 0.46) | 0.39 (0.30 to 0.46) | — | — |
| Sham | 0.32 (0.20 to 0.65) | 0.33 (0.18 to 0.58) | 0.44 (0.26 to 0.60) | 0.42 (0.23 to 0.60) | — | — | |
| Delta finger-to-palm distance ratio Mdn | PA | 0.70 (0.60 to 0.88) | 0.67 (0.61 to 0.87) | 0.73 (0.63 to 0.84) | 0.79 (0.70 to 0.82) | — | — |
| Sham | 0.69 (0.55 to 0.90) | 0.72 (0.53 to 0.88) | 0.79 (0.53 to 0.89) | 0.77 (0.60 to 0.93) | — | — | |
| Experimental tests of neuropsychological functions | |||||||
| Visuospatial attention | |||||||
| Temporal Order Judgement task (Point of Subjective Simultaneity [ms]) Mdn | PA | 0.16 (−13.82 to 9.02) | −3.26 (−14.51 to 8.35) | −1.00 (−8.65 to 9.71) | 5.18 (−1.74 to 10.87) | — | — |
| Sham | −0.05 (−7.40 to 7.06) | −0.75 (−8.55 to 6.65) | 1.17 (−6.16 to 7.33) | −2.12 (−10.48 to 6.07) | — | — | |
| Landmark task (Point of Subjective Equality[°]) Mdn | PA | 0.04 (−0.20 to 0.28) | 0.09 (−0.01 to 0.19) | 0.03 (−0.09 to 0.40) | −0.02 (−0.13 to 0.19) | — | — |
| Sham | 0.06 (−0.07 to 0.21) | 0.06 (−0.12 to 0.17) | −0.05 (−0.09 to 0.10) | 0.05 (−0.04 to 0.10) | — | — | |
| Grayscales task M | PA | 0.17 (−0.07 to 0.41) | 0.12 (−0.11 to 0.34) | 0.08 (−0.13 to 0.30) | 0.11 (−0.12 to 0.34) | — | — |
| Sham | 0.09 (−0.08 to 0.26) | 0.12 (−0.08 to 0.32) | 0.07 (−0.10 to 0.25) | 0.14 (−0.06 to 0.31) | — | — | |
| Mental representation of space | |||||||
| Mental Number Line Bisection task M | PA | −0.06 (−0.76 to 0.67) | −0.10 (−0.73 to 0.54) | 0.04 (−0.58 to 0.63) | −0.06 (−0.55 to 0.42) | — | — |
| Sham | 0.12 (−0.51 to 0.77) | 0.24 (−0.50 to 0.99) | 0.39 (−0.36 to 1.21) | 0.31 (−0.34 to 0.99) | — | — | |
| Spatially defined motor function | |||||||
| Directional hypokinesia, affected hand, index A (ms) Mdn | PA | −4.88 (−41.02 to 29.55) | −2.23 (−40.87 to 16.76) | −15.41 (−58.35 to −9.44) | −21.93 (−40.85 to −9.44) | — | — |
| Sham | −15.65 (−79.21 to 26.94) | 21.51 (−21.38 to 56.06) | −24.31 (−61.88 to −12.51) | −12.26 (−47.44 to 16.73) | — | — | |
| Directional hypokinesia, affected hand, index B (ms) Mdn | PA | −37.53 (−90.19 to 16.61) | −25.46 (−84.04 to 13.63) | −48.49 (−80.33 to −22.88) | 4.10 (−40.19 to 10.67) | — | — |
| Sham | −40.43 (−48.52 to −21.96) | −0.40 (−61.60 to 15.61) | −8.19 (−48.87 to 13.72) | 3.32 (−43.06 to 20.37) | — | — | |
| Directional hypokinesia, unaffected hand, index A (ms) Mdn | PA | 0.14 (−15.93 to 19.88) | 10.28 (1.15 to 22.22) | −6.76 (−19.29 to 13.43) | −2.78 (−45.45 to 13.43) | — | — |
| Sham | 5.57 (−24.54 to 26.03) | −7.88 (−20.59 to 14.27) | 6.88 (−15.63 to 18.92) | 2.51 (−13.48 to 23.38) | — | — | |
| Directional hypokinesia, unaffected hand, index B (ms) Mdn | PA | 4.84 (−6.43 to 11.89) | 9.41 (−17.73 to 25.19) | −3.40 (−21.35 to 33.52) | 7.43 (−26.43 to 38.21) | — | — |
| Sham | −23.63 (−48.34 to 12.93) | 9.18 (−12.92 to 28.54) | 11.01 (−10.84 to 28.46) | 16.47 (−2.91 to 26.35) | — | — | |
| Directional bradykinesia, affected hand, index A (ms) Mdn | PA | 97.95 (23.29 to 216.69) | 64.71 (22.36 to 123.85) | 46.11 (14.19 to 72.77) | 52.74 (22.18 to 66.01) | — | — |
| Sham | 3.73 (−32.67 to 67.35) | 50.72 (−5.50 to 64.21) | 31.79 (3.63 to 87.48) | 41.09 (11.92 to 64.21) | — | — | |
| Directional bradykinesia, affected hand, index B (ms) Mdn | PA | −49.68 (−125.50 to −8.16) | −180.86 (−235.79 to −16.96) | −124.70 (−129.09 to −122.32) | −78.67 (−115.85 to −42.31) | — | — |
| Sham | −63.53 (−149.00 to −57.28) | −103.18 (−170.48 to −54.09) | −77.46 (−97.96 to −17.51) | −75.60 (−99.62 to −48.41) | — | — | |
| Directional bradykinesia, unaffected hand, index A (ms) Mdn | PA | 48.80 (35.53 to 64.67) | 69.36 (35.74 to 103.71) | 79.01 (45.24 to 99.85) | 79.78 (59.27 to 116.99) | — | — |
| Sham | 86.46 (54.45 to 127.39) | 69.84 (24.68 to 113.96) | 84.79 (76.26 to 86.26) | 48.80 (35.53 to 64.67) | — | — | |
| Directional bradykinesia, unaffected hand, index B (ms) Mdn | PA | 31.39 (−13.35 to 64.92) | 69.35 (25.05 to 98.88) | 36.70 (21.07 to 63.50) | 20.37 (−13.72 to 66.72) | — | — |
| Sham | −28.35 (−71.98 to 41.21) | 3.34 (−39.16 to 44.61) | 28.60 (6.71 to 53.45) | 3.38 (−22.98 to 12.57) | — | — | |
| Body representation | |||||||
| Hand laterality recognition, accuracy index (%) M | PA | −1.65 (−5.66 to 2.34) | −2.26 (−5.68 to 1.43) | 1.30 (−2.23 to 4.37) | 1.57 (−2.70 to 6.00) | — | — |
| Sham | 2.77 (−1.32 to 7.37) | −1.77 (−5.83 to 2.21) | 3.92 (0.19 to 7.72) | 2.54 (−2.00 to 6.83) | — | — | |
| Hand laterality recognition, reaction time index (ms) M | PA | −97.74 (−268.99 to 70.43) | −57.20 (−187.91 to 70.02) | −37.44 (−155.06 to 78.98) | −130.05 (−240.98 to −27.84) | — | — |
| Sham | −236.04 (−448.24 to −65.14) | −129.37 (−263.61 to 21.19) | −28.65 (−173.14 to 95.70) | 19.77 (−112.95 to 161.67) | — | — | |
BCa 95% CI, bootstrapped bias-corrected and accelerated 95% confidence interval; CRPS, complex regional pain syndrome; LTFU1 and LTFU2, long-term follow-ups 1 and 2; M, mean; Mdn, median; PA, prism adaptation treatment; RS1, RS2, RS3, and RS4, research sessions 1, 2, 3, and 4; Sham, sham treatment.