Table 2 Effects of Prolotherapy, Physiotherapy, and Combined treatments on primary and secondary outcomes at all time points over 1 year follow-up
Outcome | Prolotherapy | Combined | Physiotherapy | Combined vs Prolotherapy | Physiotherapy vs Prolotherapy | Physiotherapy vs Combined |
|---|---|---|---|---|---|---|
PRTEE, /100 Mean (SD) | Mean improvement from baseline (95% CI)† | |||||
0 weeks | 31.6 (10.3) | 31.3 (10.8) | 33.5 (10.0) | – | – | – |
6 weeks | 24.5 (14.6) | 18.3 (12.2) | 19.7 (14.3) | 5.35 (−1.77, 12.5) | 6.31 (−0.83, 13.5) | 0.96 (− 6.23, 8.16) |
12 weeks | 18.2 (13.5) | 12.4 (10.1) | 12.2 (12.4) | 5.21 (− 0.99, 11.4) | 7.42 (1.51, 13.3)* | 2.21 (−4.29, 8.70) |
26 weeks | 8.9 (8.2) | 8.2 (10.5) | 9.3 (10.4) | −0.11 (−6.21, 5.99) | 1.01 (−4.56, 6.58) | 1.12 (−4.99, 7.24) |
52 weeks | 4.9 (7.4) | 3.9 (5.5) | 4.4 (7.0) | 0.35 (−4.91, 5.61) | 2.10 (−3.31, 7.51) | 1.75 (−2.94, 6.45) |
Pain at rest, /10 | ||||||
0 weeks | 2.0 (1.6) | 1.8 (1.5) | 2.1 (2.0) | – | – | – |
6 weeks | 1.9 (2.0) | 1.3 (1.9) | 1.5 (1.5) | 0.4 (−0.7, 1.4) | 0.7 (− 0.2, 1.7) | 0.4 (− 0.6, 1.3) |
12 weeks | 0.8 (1.3) | 0.8 (1.2) | 1.0 (1.5) | −0.3 (−1.04, 0.5) | 0.0 (− 0.8, 0.8) | 0.3 (− 0.5, 1.0) |
26 weeks | 0.3 (0.7) | 0.5 (1.7) | 0.8 (1.3) | −0.4 (−1.2, 0.5) | − 0.3 (− 1.2, 0.5) | 0.1 (− 0.9, 1.0) |
52 weeks | 0.2 (0.5) | 0.2 (0.5) | 0.2 (0.6) | − 0.2 (− 0.9, 0.5) | 0.1 (− 0.6, 0.9) | 0.3 (− 0.4, 1.1) |
Worst pain in the last week, /10 | ||||||
0 weeks | 7.4 (1.6) | 6.1 (2.4) | 7.3 (2.0) | – | – | – |
6 weeks | 5.4 (2.2) | 3.7 (2.3) | 3.7 (2.6) | 0.2 (−0.9, 1.4) | 1.5 (0.5, 2.6)* | 1.3 (0.1, 2.5)* |
12 weeks | 4.0 (2.5) | 3.0 (2.1) | 2.5 (2.6) | −0.4 (−1.6, 0.8) | 1.4 (0.2, 2.6)* | 1.7 (0.6, 2.9)* |
26 weeks | 2.0 (2.0) | 2.1 (2.1) | 1.6 (2.1) | −1.5 (−2.7, −0.2)* | 0.2 (− 1.1, 1.5) | 1.7 (0.3, 3.0)* |
52 weeks | 1.1 (2.0) | 0.9 (1.6) | 0.9 (1.6) | −1.1 (−2.3, 0.1) | 0.0 (− 1.0, 1.1) | 1.1 (0.0, 2.2)* |
PFG, affected/unaffected ratio | ||||||
0 weeks | 0.56 (0.34) | 0.55 (0.32) | 0.64 (0.55) | – | – | – |
6 weeks | 0.87 (0.57) | 0.84 (0.66) | 0.80 (0.34) | −0.03 (−0.30, 0.24) | −0.11 (− 0.37, 0.15) | −0.08 (− 0.31, 0.15) |
12 weeks | 0.79 (0.31) | 0.81 (0.46) | 1.00 (0.50) | 0.02 (−0.16, 0.19) | 0.12 (−0.13, 0.37) | 0.10 (− 0.14, 0.34) |
26 weeks | 0.92 (0.23) | 0.89 (0.39) | 1.03 (0.35) | −0.03 (− 0.22, 0.17) | 0.03 (− 0.22, 0.27) | 0.05 (− 0.20, 0.31) |
52 weeks | 1.01 (0.16) | 0.96 (0.23) | 1.05 (0.25) | −0.05 (− 0.21, 0.12) | −0.05 (− 0.27, 0.18) | −0.002 (− 0.22, 0.22) |
EuroQoL, /100 | ||||||
0 weeks | 82.7 (12.9) | 83.1 (11.2) | 80.4 (16.9) | – | – | – |
6 weeks | 80.6 (11.8) | 83.0 (11.6) | 83.9 (13.4) | 1.6 (−5.5, 8.6) | 4.9 (−4.2, 14.0) | 3.3 (−5.3, 11.9) |
12 weeks | 83.1 (9.9) | 86.2 (8.9) | 85.9 (13.6) | 2.4 (−4.1, 8.8) | 4.9 (−3.8, 13.6) | 2.5 (−5.7, 10.8) |
26 weeks | 86.3 (12.1) | 87.8 (8.9) | 87.2 (12.7) | 0.9 (−6.5, 8.4) | 2.6 (−7.1, 12.3) | 1.7 (−7.1, 10.5) |
52 weeks | 88.5 (9.3) | 86.9 (11.3) | 85.3 (17.3) | −2.4 (−9.1, 4.3) | −1.2 (−11.6, 9.3) | 1.2 (−8.7, 11.2) |
Success, number of events/total sample size (percentage) | RR (95% CI)‡ | |||||
6 weeks | 4/22 (18.2%) | 8/26 (30.8%) | 10/26 (38.5%) | 1.69 (0.59, 4.87) | 2.12 (0.77, 5.81) | 1.25 (0.59, 2.66) |
12 weeks | 13/28 (46.4%) | 19/35 (54.3%) | 19/33 (57.6%) | 1.17 (0.71, 1.93) | 1.24 (0.76, 2.03) | 1.06 (0.70, 1.62) |
26 weeks | 26/36 (72.2%) | 27/35 (77.1%) | 25/34 (73.5%) | 1.07 (0.81, 1.40) | 1.02 (0.77, 1.36) | 0.95 (0.73, 1.25) |
52 weeks | 32/35 (91.4%) | 31/33 (93.9%) | 28/34 (82.4%) | 1.03 (0.90, 1.17) | 0.90 (0.75, 1.09) | 0.88 (0.73, 1.05) |
Recurrence, number of events/total sample size (percentage) | RR (95% CI)∆ | |||||
12 weeks | 4/26 (15.4%) | 8/30 (26.7%) | 6/30 (20.0%) | 1.73 (0.59, 5.10) | 1.30 (0.41, 4.11) | 0.75 (0.30, 1.90) |
26 weeks | 5/32 (15.6%) | 9/35 (25.7%) | 6/34 (17.6%) | 1.65 (0.62, 4.40) | 1.13 (0.38, 3.34) | 0.69 (0.27, 1.72) |
52 weeks | 5/34 (14.7%) | 10/32 (31.3%) | 8/34 (23.5%) | 2.13 (0.82, 5.54) | 1.60 (0.58, 4.40) | 0.75 (0.34, 1.67) |