| Activity limitation (RMDQ23: 0 to 100 scale) | Activity limitation (PSFS: 0 to 100 scale) | Pain intensity (QVAS: 0 to 100 scale) |
---|---|---|---|
Preplanned analysis - Clinical course* | |||
Movement Biofeedback Group effect # | Â | Â | Â |
Beta coefficient (95 % CI) | −7.1(−12.6 to −1.6) p < 0.014 | −10.3(−16.6 to −3.9) p = 0.001 | −7.7(−13.0 to −2.4) p < 0.004 |
Group effect Intraclass Correlation Coefficients | Â | Â | Â |
Clinics | 0.00 | 0.04 | 0.00 |
Clinicians | 0.00 | 0.00 | 0.00 |
Patients | 0.50 | 0.37 | 0.55 |
Movement Biofeedback Group-by-time (per 100Â days) effect # | Â | Â | Â |
Beta coefficient (95 % CI) | −3.5(−5.2 to −2.2) p < 0.001 | −4.7(−7.0 to −2.5) p < 0.001 | −4.8(−6.1 to −3.5) p < 0.001 |
Group-by-time effect Intraclass Correlation Coefficients | Â | Â | Â |
Clinics | 0.00 | 0.00 | 0.00 |
Clinicians | 0.00 | 0.00 | 0.00 |
Patients | 0.51 | 0.38 | 0.59 |
Analysis n= | Sites = 8 | Sites = 8 | Sites = 8 |
Clinicians = 8 | Clinicians = 8 | Clinicians = 8 | |
Participants = 106 | Participants = 96 | Participants = 106 | |
Assessments = 644 | Assessments = 524 | Assessments = 650 | |
Additional analysis - Unadjusted comparison at individual time points** | |||
3-month outcomes | Â | Â | Â |
Movement Biofeedback Group | Â | Â | Â |
Mean (95 % CI) | 40.1 (20.7 to 59.5) | 40.0 (24.0 to 56.0) | 39.5 (21.4 to 55.7) |
Mean improvement from baseline (95 % CI) | 11.4 (7.3 to 15.5) | 18.9 (6.1 to 31.7) | 22.1 (13.6 to 30.5) |
n (%) of patients who improved by ≥30 % of baseline score | 15 (43 %) | 16 (55 %) | 17 (49 %) |
Analysis n= | 35 | 29 | 35 |
Guidelines-based Care Group | Â | Â | Â |
Mean (95 % CI) | 53.7 (31.8 to 75.6) | 58.0 (34.0 to 82.0) | 54.5 (41.1 to 67.8) |
Mean improvement from baseline (95 % CI) | −1.6 (−8.4, 5.2) | 1.3 (−8.7, 11.4) | 9-4 (2.4 to 16.3) |
n (%) of patients who improved by ≥30 % of baseline score | 6 (16 %) | 12 (40 %) | 12 (32 %) |
Analysis n= | 37 | 30 | 37 |
Difference between group means # | −13.0 (−18.5 to 7.5) | −17.6 (−28.9 to −6.3) | −12.7 (−20.2 to −5.1) |
Comparison between groups of probability of improving by ≥30 % = risk ratio (95 % CI) †| 2.6 (1.2 to 6.0) | 1.4 (0.8 to 2.4) | 1.5 (0.8 to 2.7) |
12Â month outcomes | Â | Â | Â |
Movement Biofeedback Group | Â | Â | Â |
Mean (95 % CI) | 31.3 (8.9 to 53.7) | 31.0 (22.0 to 41.0) | 33.1 (17.7 to 48.6) |
Mean improvement from baseline (95 % CI) | 19.7 (15.4 to 24.0) | 28.1 (20.4 to 35.9) | 27.5 (21.7 to 33.3) |
n (%) of patients who improved baseline score by ≥30 % of baseline score | 26 (60 %) | 31 (78 %) | 30 (68 %) |
Analysis n= | 43 | 40 | 44 |
Guidelines-based Care Group | Â | Â | Â |
Mean (95 % CI) | 47.7 (36.2 to 59.2) | 54.0 (42.0 to 64.0) | 56.2 (52.4 to 60.1) |
Mean improvement from baseline (95 % CI) | 1.5 (−4.2 to 7.2) | 3.2 (−8.6 to 15.0) | 5.4 (3.3 to 7.4) |
n (%) of patients who improved baseline score by ≥30 % of baseline score | 12 (25 %) | 12 (32 %) | 10 (21 %) |
Analysis n= | 47 | 38 | 48 |
Difference between group means ## | −18.2 (−23.1 to −13.2) | −24.9 (−34.7 to −15.2) | −22.2 (−26.4 to −17.9) |
Comparison between groups of probability of improving by ≥30 % = risk ratio (95 % CI) †| 2.4 (1.4 to 4.1) | 2.5 (1.5 to 4.0) | 3.3 (1.8 to 5.9) |