Background
Methods
Patient selection
Methods in Group I
Technique of radiofrequency percutaneous facet denervation
Technique of diagnostic block and radiofrequency lesioning of the cervical segmental nerves
Methods in Group II
Technique of blocking the greater occipital nerve (GON)
Evaluation
Statistical analysis
Results
Demographic and clinical characteristics
RF (Group I)
|
Control (Group II)
| |
---|---|---|
Number of patients (n) | 15 | 15 |
Mean age (SD) [min/max] (yr) | 47,5 (11,0) [22/62] | 49,1 (12,8) [28/64] |
Male/female (n) | 4/11 | 4/11 |
Duration of pain (yr) | 9,7 | 6,6 |
SCL-90 psychoneurotism (SD) | 146,3 (29,8) | 135,4 (25,0) |
Mean VAS/4 weeks (SD) | 68,1 (12,7) | 76,5 (16,6) |
Days headache/4 weeks (SD) | 25,9 (5,0) | 19,0 (9,3) |
Medicine use/week (SD) | 6,7 (5,0) | 5,8 (8,3) |
Headache intensity/week (SD) | 2,1 (0,4) | 1,9 (0,4) |
Rand-36 (SD): | ||
PF
| 70,0 (21,4) | 57,0 (24,6) |
SF
| 71,7 (18,0) | 59,2 (23,4) |
RP
| 31,7 (34,7) | 36,7 (35,2) |
RE
| 64,4 (38,8) | 66,7 (35,6) |
MH
| 65,3 (16,2) | 69,6 (16,8) |
VI
| 53,7 (24,3) | 45,3 (15,2) |
BP
| 41,8 (19,4) | 38,1 (18,5) |
GH
| 58,7 (21,0) | 54,7 (18,5) |
MPI (SD): | ||
Pain severity
| 45,6 (9,6) | 36,8 (13,6) |
Interference
| 42,0 (14,1) | 44,6 (15,9) |
Life control
| 55,0 (8,4) | 58,0 (9,2) |
Affective distress
| 48,0 (9,6) | 41,9 (9,8) |
Support
| 52,5 (9,8) | 51,8 (8,6) |
Punishing responses
| 48,1 (9,5) | 45,5 (7,1) |
Solicitous responses
| 53,3 (10,8) | 51,3 (10,4) |
Distracting responses
| 50,4 (13,2) | 46,5 (9,4) |
Household chores
| 48,4 (9,9) | 48,5 (11,1) |
Outdoor work
| 53,5 (9,4) | 56,5 (15,9) |
Social activities
| 54,4 (12,0) | 52,7 (12,0) |
General activity
| 52,8 (12,0) | 53,9 (12,0) |
randomisation and follow-up of the study (Figure 1) (Table 2)
T0 Step I
| T1 (= 8 weeks) Step II
| T2 (= 16 weeks) Step III
| |||||
---|---|---|---|---|---|---|---|
Patient number | Randomization | GPE | VAS success | Follow-up treatment | GPE | VAS success | TENS |
1 | GON | 0 | _ | GON | -1 | _ | Yes, - |
2 | PFD C3–C6 | 0 | _ | Patient does not want follow-up treatment | Missing | + | No |
3 | GON | +2 | _ | No | 0, again GON | _ | No |
4 | PFD C3–C6 | +1 | + | Prog C2, prog C3 Policy: RF C2 | Missing | + | No |
5 | PFD C3–C6 | -1 | + | Patient does not want follow-up treatment | OS | OS | OS |
6 | GON | -1 | + | GON | 1 | + | No |
7 | GON | 0 | + | Heart catheterization, no follow-up treatment | 2 | _ | No |
8 | PFD C3–C6 | +2 | _ | No | 1 | + | No |
9 | PFD C3–C6 | 0 | _ | Progn. C2, C3, C5: all no effect | 0 | + | Yes, - |
10 | GON | +1 | + | GON | 2 | _ | Yes, + |
11 | PFD C3–C6 | +1 | + | Prog C2, prog C3 Policy: RF C2 | 1 | + | Yes, + |
12 | GON | +2 | + | No | 2 | + | No |
13 | PFD C3–C6 | -2 | _ | Yes, but patient had no time to come anymore | OS | OS | OS |
14 | PFD C3–C6 | +2 | _ | No | 2 | Missing | No |
15 | GON | +3 | Missing | No | 2 | _ | No |
16 | GON | +1 | + | GON | 0 | + | Yes, + |
17 | GON | -2 | _ | GON | 1 | Missing | Yes, + |
18 | GON | 0 | + | PFD C3-C6 | 0 | + | Yes, - |
19 | PFD C3–C6 | -2 | + | OS, not very content with the treatment | OS | OS | OS |
20 | PFD C3–C6 | +2 | + | No | -2 | _ | Yes, + |
21 | GON | +2 | + | No | 2 | + | No |
22 | PFD C3–C6 | 0 | + | Progn. C2, progn. C3: all no effect | 1 | + | Yes, - |
23 | PFD C3–C6 | +2 | + | No | 2 | + | No |
24 | GON | +1 | + | GON | 0 | _ | Yes, OS |
25 | PFD C3–C6 | 0 | + | Progn. C2, C3, C4: all no effect | 0 | + | Yes, - |
26 | GON | OS | Missing | OS | OS | Missing | OS |
27 | PFD C3–C6 | 0 | + | Progn. C2, C3. Policy: RF C3 | +1 | + | Yes, - |
28 | GON | +1 | _ | GON | -2 | _ | Yes, + |
29 | GON | -2 | _ | OS, does not want any treatment | OS | OS | OS |
30 | PFD C3–C6 | 0 | + | Progn. C2, C3: all no effect | -2 | _ | Yes, + |
Group I
Group II
Difference in VAS, days of headache and intensity of headache of both groups compared to the initial values (Table 3)
RF (Group I)
Mean (SD)
|
Control (Group II)
Mean (SD)
|
p
|
95% CI
| |
---|---|---|---|---|
VAS difference | ||||
T1-T0
| 30,5 (17,3) | 32,4 (24,7) | 0,81 | -14,4 to 18,3 |
T2-T0
| 29,9 (13,8) | 21,0 (35,5) | 0,41 | -31,2 to 13,5 |
T3-T0
| 28,9 (20,3) | 24,6 (35,0) | 0,69 | -26,6 to 17,9 |
T6-T0
| 30,2 (12,4) | 26,8 (37,7) | 0,75 | -25,8 to 19,1 |
Headache difference | ||||
T0 T1
| 4,2 (5,1) | 5,5 (8,7) | 0,62 | -4,3 to 7,1 |
T0 T2
| 4,1 (4,1) | 3,9 (6,3) | 0,94 | -4,5 to 4,2 |
T0 T3
| 7,5 (7,1) | 4,5 (6,1) | 0,27 | -8,3 to 2,4 |
T0 T6
| 5,6 (5,7) | 6,8 (7,7) | 0,65 | -4,2 to 6,7 |
Intensity difference | ||||
T0 T1
| 1,5 (4,0) | - 0,5 (8,7) | 0,43 | -3,1 to 7,1 |
T0 T2
| 2,3 (4,2) | -1,0 (9,6) | 0,23 | -2,2 to 8,9 |
T0 T3
| 3,1 (4,5) | - 0,6 (9,2) | 0,18 | -1,8 to 9,2 |
T0 T6
| 3,7 (8,7) | - 0,4 (9,4) | 0,24 | -2,9 to 10,9 |
Percentage VAS improving | ||||
T1
| 43,9 (22,0) | 42,4 (28,6) | 0,87 | -21,2 to 18,1 |
T2
| 45,4 (23,9) | 24,1 (50,1) | 0,17 | -52,0 to 9,5 |
T3
| 41,7 (28,5) | 28,0 (49,4) | 0,38 | -45,0 to 17,6 |
T6
| 44,4 (16,8) | 30,7 (49,9) | 0,34 | -43,5 to 16,1 |
Positive global perceived effects (GPE of +2 or +3) and/or a successful VAS-difference (Table 4)
T1 (= 8 weeks) | T2 (= 16 weeks) | T6 (= 1 year) | |||||||
---|---|---|---|---|---|---|---|---|---|
Group I
|
Group II
|
Total
|
Group I
|
Group II
|
Total
|
Group I
|
Group II
|
Total
| |
n with success (%) | 12 (80%) | 10 (66,7%) | 22 (73,3%) | 10 (66,7%) | 8 (53,3%) | 18 (60%) | 8 (53,3%) | 7 (46,7%) | 15 (50%) |
n no success (%) | 3 (20%) | 4 (26,7%) | 7 (23,3%) | 2 (13,3%) | 5 (33,3%) | 7 (23,3%) | 2 (13,3%) | 3 (20%) | 5 (16,7%) |
n no data (%) | 1 (6,7%) | 1 (3,3%) | 3 (20%) | 2 (13,3%) | 5 (16,7%) | 5 (33,3%) | 5 (33,3%) | 10 (33,3%) |