Background
Methods
Design overview
Settings and participants
Randomization and interventions
Manual therapy
Physical therapy
Co-interventions
Outcomes and follow-up
Prognostic factors
Primary outcomes
Secondary outcomes
Sample size
Statistical analysis
Results
Patient characteristics and baseline similarities
Variable | MTU (n = 90) | PT (n = 91) |
---|---|---|
Age (in years, mean; SD) | 49.2 (12.4) | 48.7 (12.6) |
Gender female (n; %) | 56 (62.2) | 56 (61.5) |
First time neck complaints (n; %) | 56 (62.2) | 58 (63.7) |
3 or more musculoskeletal complaints | 54 (60.0) | 55 (59.8) |
4 or more musculoskeletal complaints | 27 (30.0) | 26 (28.3) |
Combined neck and back pain | 15 (16.7) | 16 (17.4) |
Last Year visit GP for neck complaints (n; %) | 23 (25.6) | 26 (28.6) |
Last Year visit any therapist for neck (n; %) | 17 (18.9) | 20 (22.0) |
Main complaints (n; %) | ||
Pain | 79 (87.8) | 80 (87.9) |
Stiffness | 30 (33.3) | 38 (41.8) |
Mobility impairment | 33 (36.7) | 37 (40.7) |
Other | 7 (7.8) | 10 (11.0) |
Complain intensity (NRS 0–10) | ||
Main complaint (mean; SD) | 6.9 (1.3) | 6.8 (1.4) |
Second complaint (mean; SD) | 6.0 (1.6) | 5.9 (1.8) |
Third complaint (mean; SD) | 5.1 (2.1) | 5.3 (2.0) |
NDI (0–50) (mean; SD) | ||
12.5 (6.8) | 11.7 (5.4) | |
NRS pain (0–10) (mean; SD) | ||
5.5 (2.0) | 5.8 (1.8) | |
FABQ (mean; SD) | ||
Total (0–96) | 30.0 (16.4) | 29.6 (15.1) |
Subscale work (0–66) | 14.7 (13.5) | 14.8 (12.3) |
Subscale physical activity (0–30) | 15.3 (5.4) | 14.8 (5.7) |
SF-36 (mean; SD) | ||
Physical component summary (0–100) | 44.6 (7.9) | 44.6 (7.1) |
Mental component summary (0–100) | 46.4 (12.5) | 47.2 (10.0) |
CEQ (mean; SD) | ||
Credibility (0–27) | 22.0 (3.4) | 22.4 (3.2) |
Expectancy (0–27) | 21.9 (4.8) | 22.1 (4.7) |
Intervention preference (n; %) | ||
None | 61 (67.8) | 63 (69.2) |
Manual therapy | 20 (22.2) | 20 (22.0) |
Physical therapy | 9 (10.0) | 8 (8.8) |
Pre-stratification | ||
A. NRS main complaint ≤ 6, age ≤ 39 | 5 | 6 |
B. NRS main complaint ≤ 6, age ≥ 40 | 23 | 23 |
C. NRS main complaint ≥ 7, age ≤ 39 | 16 | 16 |
D. NRS main complaint ≥ 7, age ≥ 40 | 46 | 46 |
(Intention-to-treat) analysis
Variables | Manual therapy Utrecht (n = 90) | Physiotherapy (n = 91) | Regression coefficients (95% CI) | |
---|---|---|---|---|
Primary outcomes measures | ||||
GPE (success, %) | OR (95% CI) |
P
| ||
Overall effect: P = 0.20 | ||||
3 weeks. | 30.7 | 14.8 | 3.97 (1.31 to 12.04) | 0.02** |
7 weeks. | 51.7 | 42.4 | 1.90 0.69 to 5.20) | 0.21 |
13 weeks. | 60.7 | 57.0 | 1.11 (0.39 to 3.15) | 0.84 |
26 weeks. | 57.5 | 59.5 | 0.76 (0.26 to 2.18) | 0.61 |
52 weeks. | 64.9 | 56.0 | 1.72 (0.61to 4.88) | 0.31 |
NDI (0–50) (M, SD) | Regression Coefficients (95% CI) |
P
| ||
Overall effect: P =0.57 | ||||
Baseline | 12.5 (6.8) | 11.7 (5.4) | ||
3 weeks. | 10.5 (6.9) | 10.2 (5.6) | −0.24 (−1.65 to 1.16) | 0.74 |
7 weeks. | 7.8 (6.4) | 8.1 (7.1) | −0.69 (−2.14 to 0.76) | 0.35 |
13 weeks. | 5.9 (5.8) | 5.9 (4.6) | −0.23 (−1.67 to 1.21) | 0.75 |
26 weeks. | 5.9 (5.5) | 5.6 (5.6) | 0.34 (−1.11 to 1.80) | 0.64 |
52 weeks. | 5.9 (5.7) | 6.6 (6.5) | −0.82 (−2.25 to 0.61) | 0.26 |
Secondary outcomes measures | ||||
NRS-P (0–10) (M, SD) | ||||
Overall effect: P = 0.76 | ||||
Baseline | 5.5 (2.0) | 5.8 (1.8) | ||
3 weeks. | 4.2 (2.3) | 4.6 (2.1) | −0.27 (−0.94 to 0.40) | 0.42 |
7 weeks. | 3.2 (2.3) | 3.6 (2.4) | −0.20 (−0.87 to 0.47) | 0.56 |
13 weeks. | 2.8 (2.5) | 2.6 (2.0) | 0.24 (−0.44 to 0.93) | 0.49 |
26 weeks. | 2.9 (2.4) | 2.3 (2.2) | 0.78 (0.09 to 1.47) | 0.03** |
52 weeks. | 2.5 (2.6) | 2.8 (2.6) | −1.14 (−0.82 to 0.54) | 0.69 |
Responder analyses | ||||
MCID NDI (success, %) | OR (95% CI) |
P
| ||
Overall effect: P = 0.95 | ||||
3 weeks. | 31.0 | 20.7 | 2.08 (0.79 to 5.43) | 0.14 |
7 weeks. | 56.3 | 52.0 | 1.26 (0.49 to 3.24) | 0.63 |
13 weeks. | 66.3 | 65.8 | 0.97 (0.37 to 2.53) | 0.95 |
26 weeks. | 62.0 | 69.6 | 0.55 (0.21 to 1.47) | 0.23 |
52 weeks. | 60.5 | 63.1 | 0,79 (0.31 to 2.02) | 0.63 |
MCID NRS-P (success, %) | ||||
Overall effect: P = 0.11 | ||||
3 weeks. | 34.9 | 37.2 | 0.87 (0.38 to 2.14) | 0.73 |
7 weeks. | 55.2 | 56.6 | 0.95 (0.42 to 2.14) | 0.89 |
13 weeks. | 59.4 | 65.2 | 0.56 (0.23 to 1.38) | 0.21 |
26 weeks. | 58.2 | 79.5 | 0.25 (0.10 to 0.63) | 0.00** |
52 weeks. | 69.1 | 69.9 | 0.93 (0.39 to 2.25) | 0.88 |
Adverse events
Adverse events | 3 weeks | 7 weeks | 13 weeks | ||||||
---|---|---|---|---|---|---|---|---|---|
MTU | PT | p | MTU | PT | p | MTU | PT | p | |
Number | 40 | 31 | 0.1723 | 31 | 23 | 0.1964 | 17 | 12 | 0.3179 |
Severity (NRS) | 4.8 (3.9) | 5.3 (2.6) | 0.3607 | 4.1 (3.1) | 3.8 (2.8) | 0.6456 | 4.9 (3.0) | 3.6 (2.8) | 0.2508 |
Time of onset (n) | |||||||||
< 30 min. | 4 | 7 | 5 | 4 | 3 | 0 | |||
>30 min. < 4 h. | 14 | 7 | 5 | 4 | 2 | 3 | |||
> 4 h., < 24 h. | 11 | 8 | 11 | 8 | 3 | 1 | |||
> 24 h. | 7 | 6 | 5 | 5 | 6 | 1 | |||
Duration (n) | |||||||||
< 10 min. | 0 | 0 | 3 | 2 | 4 | 1 | |||
> 10 min., < 1 h. | 4 | 5 | 1 | 2 | 2 | 0 | |||
> 1 h., < 24 h. | 13 | 9 | 10 | 5 | 8 | 3 | |||
> 24 h. | 20 | 13 | 13 | 12 | 4 | 2 |