| GPR Group (n = 50) | SE Group (n = 50) |  | ||
---|---|---|---|---|---|
Intention to treat | mean (SD) | Changea mean (SD) | mean (SD) | Changea mean (SD) | P -valueb |
RMDQ (0-24) | Â | Â | Â | Â | Â |
   Baseline | 7.1 (5.3) | -- | 5.9 (4.6) | -- |  |
   3 months | 3.1 (3.9) | -4.0 (5.2) | 5.6 (5.3) | -0.3 (4.1) | < 0.001 |
   6 months | 2.9 (3.5) | -4.2 (5.8) | 5.4 (5.0) | -0.5 (2.9) | < 0.001 |
ODI (0-100%) | Â | Â | Â | Â | Â |
   Baseline | 22.5 (15.2) | -- | 22.2 (12.2) | -- |  |
   3 months | 12.2 (12.8) | -10.4 (15.0) | 22.0 (15.6) | -0.2 (10.8) | < 0.001 |
   6 months | 12.3 (12.0) | -10.3 (17.9) | 21.1 (15.4) | -1.1 (9.5) | 0.002 |
FFT (cm) | Â | Â | Â | Â | Â |
   Baseline | 15.7 (12.5) | -- | 16.1 (12.9) |  |  |
   3 months | 8.6 (9.4) | -7.2 (8.9) | 15.4 (13.3) | -0.7 (11.8) | 0.003 |
   6 months | 7.0 (9.1) | -8.8 (11.5) | 13.5 (12.3) | -2.6 (12.2) | 0.011 |
VAS (0-100 mm) | Â | Â | Â | Â | Â |
   Baseline | 60.9 (23.9) | -- | 57.7 (22.0) | -- |  |
   3 months | 23.9 (23.6) | -37.0 (29.4) | 52.0 (25.0) | -5.7 (25.6) | < 0.001 |
   6 months | 31.5 (25.6) | -29.4 (31.8) | 49.4 (24.8) | -8.3 (22.4) | < 0.001 |
Per protocol | mean (SD) | Changea mean (SD) | mean (SD) | Changea mean (SD) | P-valueb |
RMDQ (0-24) | Â | Â | Â | Â | Â |
   Baseline | 7.1 (5.3) | -- | 5.9 (4.6) | -- |  |
   3 months | 2.7 (3.5)c | -4.3 (5.2)c | 6.0 (5.2)d | 0.2 (4.4)d | < 0.001 |
   6 months | 2.6 (2.9)e | -3.8 (5.2)e | 5.4 (4.8)f | 0.1 (3.0)f | < 0.001 |
ODI (0-100%) | Â | Â | Â | Â | Â |
   Baseline | 22.5 (15.2) | -- | 22.2 (12.2) | -- |  |
   3 months | 11.0 (11.7)c | -11.4 (14.9)c | 23.4 (16.1)d | 1.3 (11.6)d | < 0.001 |
   6 months | 11.8 (11.0)e | -9.8 (16.4)e | 20.9 (16.1)f | 0.2 (10.8)f | 0.003 |
FFT (cm) | Â | Â | Â | Â | Â |
   Baseline | 15.7 (12.5) | -- | 16.1 (12.9) | -- |  |
   3 months | 7.8 (9.0)c | -7.7 (9.0)c | 15.8 (13.5)d | 0.6 (12.9)d | < 0.001 |
   6 months | 6.1 (8.9)e | -9.3 (12.1)e | 13.1 (12.2)f | -1.4 (13.6)f | 0.008 |
VAS (0-100 mm) | Â | Â | Â | Â | Â |
   Baseline | 60.9 (23.9) | -- | 57.7 (22.0) | -- |  |
   3 months | 20.9 (20.8)c | -39.3 (28.7)c | 51.1 (26.8)d | -3.0 (28.1)d | < 0.001 |
   6 months | 30.5 (24.0)e | -29.7 (30.7)e | 48.2 (26.2)f | -5.6 (22.9)f | < 0.001 |