Background
Methods
Trial design
Participants
Randomization
Decision model for treatment
Treatment categories of the model
Main category | Test | Cut-off criteria | Treatment component |
---|---|---|---|
1. Reduced cervical flexibility | 1.1 Upper cervical | ||
a) Flexion-extension | a) < 68° | Upper cervical mobilization and ROM treatment and training | |
b) Passive rotation in max flexion | b) <32° | ||
Qualifier: a) or b) | |||
1.2 Lower cervical | |||
a) Flexion-extension | a) <17° | Lower cervical mobilization and ROM treatment and training | |
1.3 Upper and lower cervical | |||
a) Axial rotation | a) <109° | Upper and lower mobilization and ROM treatment and training | |
2. Impaired cervical muscle strength-endurance and functional strength | 2.1 Cranio-cervical flexion (CCF) | ||
a) Maximal voluntary contraction (MVC) | a) < 2.5 Nm | CCF-exercises | |
b) Endurance (50 % MVC) | b) < 20 s | ||
Qualifier: a) or b) | |||
2.2 Cervico-thoracic | |||
a) Flexion MVC | a) < 40 N | Strength training cervico-thoracic muscles | |
b) Extension MVC | b) < 140 N | ||
Qualifier: a) or b) | |||
2.3 Lifting ability | |||
a) C-PILE | a) < 0.12 kg/kga | Strength training of shoulder-arm muscles | |
b) Subjective ability to carry and lift | b) ≥ 4 on the scale 1-6…how do you manage to carry/lift? | ||
1 = very good; 6 = very bad [51] | |||
Qualifier: a) and b) | |||
3. Impaired sensor-motor control | 3.1 Symptoms and activity limitations | Combinations of dizziness, balance disturbances, headache and difficulties to rotate the head [51]. | Cervical repositioning/movement control, oculomotor exercises |
3.2 Peak speed of cervical axial rotation | <170°/s | Peak speed training in cervical axial rotation | |
4. Trapezius myalgia | 4.0 | ||
a) Physiotherapy assessment | EMG-biofeedback training, a progressive program with 8 standardized exercises | ||
b) PPT upper trapezius muscles | b) < 175 kPa right; < 168 kPa left | ||
Qualifier: a) and b) | |||
5. Cervicogenic headache | 5.0 | ||
a) Physiotherapy assessment | Mobilization of upper cervical, CCF-exercise, endurance training for scapular muscles, postural correction | ||
b) Range of motion |
Rules for the decision model
Component 1 | Component 2 |
---|---|
1.1. Upper cervical ROM | 3.2. Peak speed of cervical axial rotation |
1.2. Lower cervical ROM | 3.2. Peak speed of cervical axial rotation |
1.3. Upper and lower cervical ROM, axial rotation | 3.2. Peak speed of cervical axial rotation |
3.1. Symptoms and activity limitations | 3.2. Peak speed of cervical axial rotation |
1.1. Upper cervical ROM | 1.2 Lower cervical ROM |
1.1. Upper cervical ROM | 1.3. Upper and lower cervical ROM, axial rotation |
1.2. Lower cervical ROM | 1.3. Upper and lower cervical ROM, axial rotation |
1.1. Upper cervical ROM | 1.3. Upper and lower cervical ROM, axial rotation |
+1.2. Lower cervical ROM |
Intervention procedures
Tailored treatment
Non-tailored treatment
Treatment-as-usual
Outcomes
Sample size
Blinding
Statistical methods
Results
Recruitment and participants
Demographics | Tailored treatment (n = 40) | Non-tailored treatment (n = 40) | Treatment-as-usual (n = 40) |
---|---|---|---|
Age, years, mean (SD) | 47 (11.2) | 48 (12.6) | 47 (11.1) |
Weight, kg, mean (SD) | 68.9 (12.5) | 66.8 (10.5) | 68 (14.4) |
BMI, kg/m2, mean (SD) | 24.7 (4) | 24.5 (3.7) | 24.8 (4.9) |
Use of tobacco (n); smoker/snuffera | 1/3 | 1/4 | 1/8 |
Physical activity, leisureb median (IQR) | 5 (4-5) | 4 (4-4.5) | 5 (4.5-5) |
Physical activity, workc median (IQR) | 2 (1.5-2) | 2 (1.5-2.5) | 1 (1-1.5) |
Duration of pain, month, median (IQR) | 63.5 (24-144) | 66 (24-150) | 60 (23.5–120) |
Tailored treatment (n = 34) | Non-tailored treatment (n = 36) | Treatment-as-usual (n = 33) | |
---|---|---|---|
Participants searched care | 4 | 6 | 16 |
Work absence days (n) | 2 (1) | 5 (3) | 7 (4) |
# Visits (participants): | |||
Medical doctor | 1 (1) | 1 (1) | 1 (1) |
Physiotherapist | 8 (2) | 46 (9) | |
Naprapath | 5 (2) | 2 (1) | |
Masseur | 7 (3) | 16 (4) | 21 (7) |
Total # Visits (participants) | 8 (4) | 30 (6) | 70 (16) |
Primary outcomes
TT | NTT | TAU | TT vs NTT | TT vs TAU | NTT vs TAU | |
---|---|---|---|---|---|---|
Estimated mean (SD) | Estimated mean (SD) | Estimated mean (SD) | Effectsb (95 % CI) | Effectsb (95 % CI) | Effectsc (95 % CI) | |
NRS | ||||||
Baseline | 4.55 (2.08) | 4.57 (2.08) | 4.72 (2.08) | |||
3 month | 2.62 (2.04) | 2.56 (2.04) | 3.97 (2.04) | −0.09 (-0.48 to 1.5) | 1.17 (0.15 to 2.19)* | 1.26 (0.27 to 2.25)* |
9 month | 2.85 (2.04) | 3.31 (2.04) | 3.5 (2.07) | 0.43 (-1.55 to 2.41) | 0.47 (-0.52 to 1.46) | 0.04 (-0.95 to 1.03) |
15 month | 3.06 (2.04) | 2.85 (2.04) | 3.6 (2.07) | −0.24 (-2.22 to 1.74) | 0.41 (-0.58 to 1.4) | 0.65 (-0.34 to 1.64) |
NDI | ||||||
Baseline | 21.84 (10.18) | 24.39 (10.18) | 24.18 (10.05) | |||
3 month | 14.62 (9.85) | 14.39 (9.96) | 21.74 (9.93) | −2.78 (-6.85 to 1.29) | 4.78 (0.67 to 8.89)* | 7.56 (3.49 to 11.63)*** |
9 month | 14.84 (9.85) | 16.61 (9.96) | 19.65 (9.93) | −0.78 (-4.87 to 3.31) | 2.47 (-1.64 to 6.58) | 3.25 (-0.82 to 7.32) |
15 month | 15.20 (9.85) | 13.80 (9.96) | 17.99 (9.94) | −3.95 (-8.02 to 0.12) | 0.45 (-3.64 to 4.54) | 4.40 (0.35 to 8.45)* |
Secondary outcomes
Secondary Outcomes | TT | NTT | TAU | TT vs NTT | TT vs TAU | NTT vs TAU |
---|---|---|---|---|---|---|
Estimated mean (SD) | Estimated mean (SD) | Estimated mean (SD) | Effectsb (95 % CI) | Effectsb (95 % CI) | Effectsc (95 % CI) | |
ProFitMap intensity | ||||||
Baseline | 71.64 (11.38) | 71.55 (11.38) | 70 (11.38) | |||
3 month | 79.61 (11.02) | 80.84 (11.16) | 72.07 (11.07) | −1.31 (-3 to 5.62) | 5.9 (1.51 to 10.29)** | 7.21 (2.88 to 11.54)** |
9 month | 78.48 (11.07) | 81.49 (11.16) | 75.91 (11.24) | −3.09 (-1.22 to 7.40) | 0.92 (-3.49 to 5.33) | 4.01 (-0.32 to 8.34) |
15 month | 78.5 (11.02) | 82.1 (11.22) | 76.98 (11.18) | −3.67 (-0.64 to 7.98) | −0.13 (-4.48 to 4.22) | 3.54 (-0.79 to 7.87) |
ProFitMap frequency | ||||||
Baseline | 66.02 (14.67) | 67.74 (14.67) | 64.08 (14.67) | |||
3 month | 78.19 (14.05) | 78.69 (14.22) | 67.28 (14.16) | 1.22 (-3.91 to 6.35) | 8.97 (3.74 to 14.2)*** | 7.73 (2.56 to 12.9)** |
9 month | 75.74 (14.05) | 76.09 (14.28) | 71.44 (14.25) | 1.38 (-3.75 to 6.51) | 2.36 (-2.85 to 7.57) | 0.98 (-4.19 to 6.15) |
15 month | 75.76 (14.05) | 78.73 (14.34) | 72.88 (14.25) | −1.24 (-6.41 to 3.9 ) | 0.95 (-4.26 to 3.61) | 2.19 (-2.98 to 7.36) |
PGICS | ||||||
3 month | 2.20 (1.1) | 2.19 (1.14) | 3.64 (1.1) | 0.01 (-0.52 to 0.54) | 1.44 (0.9 to 1.98)*** | 1.45 (0.93 to 1.97)*** |
9 month | 2.5 (1.16) | 2.53 (1.14) | 3.13 (1.18) | 0.04 (-0.49 to 0.57) | 0.8 (0.31 to 1.29)** | 0.85 (0.38 to 1.32)*** |
15 month | 2.49 (1.16) | 2.47 (1.14) | 3.18 (1.18) | −0.005 (-0.48 to 0.46) | 0.75 (0.28 to 1.22)** | 0.75 (0.28 to 1.22)** |
PPT right | ||||||
Baseline | 223.4 (102.7) | 209.8 (102.8) | 209.2 (102.8) | |||
3 month | 251.6 (99.5) | 237 (100.4) | 203.3 (100.2) | 1.03 (-38.4 to 40.4) | 34.1 (-6.1 to 74.3) | 33.06 (-6.6 to 72.8) |
9 month | 251.5 (100.1) | 263 (100.5) | 228.4 (102.3) | −25.10 (-65.7 to 14.5) | 8.92 (-31.4 to 49.3) | 34.03 (-5.7 to 73.7) |
PPT left | ||||||
Baseline | 218.1 (95.8) | 204.9 (95.8) | 212.3 (95.8) | |||
3 month | 247.6 (93.3) | 223.4 (94.1) | 197.3 (94.2) | 11.01 (-28.8 to 50.9) | 44.49 (3.7 to 85.2)* | 33.47 (-6.6 to 73.6) |
9 month | 244.8 (94.1) | 243.7 (93.5) | 224.6 (95.6) | −11.99 (-52.1 to 28.1) | 14.46 (-26.3 to 55.2) | 26.45 (-13.65 to 66.6) |
Work Quantity | ||||||
Baselined | 8.51 (1.58) | 8.79 (1.58) | 7.95 (1.51) | |||
3 month | 9.23 (1.63) | 9.15 (1.56) | 8.91 (1.51) | 0.36 (-0.46 to 1.18) | −0.25 (-1.07 to 0.57) | −0.61 (-1.47 to 0.19) |
9 month | 9.58 (1.63) | 9.24 (1.56) | 8.94 (1.53) | 0.62 (-0.2 to 1.44) | 0.07 (-0.75 to 0.89) | −0.55 (-1.16 to 0.25) |
15 month | 9.75 (1.63) | 9.09 (1.56) | 9.5 (1.53) | 0.94 (0.12 to 1.76)* | −0.32 (-1.14 to 0.5) | −1.26 (-2.06 to -0.46)** |
Work Quality | ||||||
Baselinee | 7.43 (1.83) | 8.32 (1.89) | 7.53 (1.86) | |||
3 month | 8.77 (1.86) | 9.06 (1.8) | 8.58 (1.74) | 0.61 (-0.31 to 1.53) | 0.28 (-0.64 to 1.2) | −0.32 (-1.22 to 0.58) |
9 month | 9.18 (1.86) | 9.0 (1.8) | 8.52 (1.77) | 1.08 (0.16 to 2)* | 0.76 (-0.16 to 1.68) | −0.32 (-1.22 to 0.58) |
15 month | 9.36 (1.86) | 9.09 (1.8) | 9.11 (1.77) | 1.17 (0.25 to 2.09)* | 0.34 (-0.58 to 1.26) | −0.82 (-1.72 to 0.08) |