Preliminary results, methodological considerations and recruitment difficulties of a randomised clinical trial comparing two treatment regimens for patients with headache and neck pain

Table 4 Differences in secondary outcome measures

Variable	Treatment Group	Follow-up week 7	Follow-up week 12	Follow-up week 26
VASHA3M (mm) Mean ± SD	UC	/	45.14 ± 25.71	38.43 ± 27.60
	UCMT	/	44.12 ± 24.15*	37.11 ± 26.52*
	Mean Diff	/	0.92	1.32
	CI	/	-25.92; 27.76	-28.27; 30.91
VASHA4W (mm) Mean ± SD	UC	40.78 ± 29.32*	36.78 ± 23.59*	32.11 ± 28.20*
	UCMT	40.73 ± 27.87*	28.00 ± 22.89*	33.18 ± 29.31*
	Mean Diff	0.05	8.78	-1.07
	CI	-26.88: 26.98	-13.14; 30.69	-28.29; 26.15
VASHANOW (mm) Mean ± SD	UC	31.91 ± 29.37	34.09 ± 28.19	13.55 ± 24.23
	UCMT	15.33 ± 24.33	15.25 ± 27.76	19.92 ± 29.09
	Mean Diff	16.57	18.84	-6.37
	CI	-6.73; 39.88	-5.44; 43.12	-29.71; 16.97
VASNP3M (mm) Mean ± SD	UC	/	24.29 ± 21.37*	24.43 ± 20.70*
	UCMT	/	28.67 ± 18.26	16.11 ± 18.56
	Mean Diff	/	-4.38	8.32
	CI	/	-25.63; 16.87	-12.77; 29.40
VASNPNOW (mm) Mean ± SD	UC	23.00 ± 29.18*	16.86 ± 22.39*	14.71 ± 20.23*
	UCMT	15.44 ± 22.02	18.56 ± 27.97	8.44 ± 15.36
	Mean Diff	7.66	-1.70	6.27
	CI	-19.83; 34.94	29.51; 26.11	-12.77; 25.31
50% Reduction HA Frequency. Number achieved/not achieved	UC	12/5	11/6	12/1
	UCMT	12/2	11/3	12/2
	Diff Prop	15%	14%	6%
Absenteeism (number absent/not absent)	UC	1/15	1/14	2/9
	UCMT	0/13	1/12	2/11
	Diff Prop	6%	1%	3%

VASHA3M: Average Headache Intensity of the last three months, VASHA4W Average Headache Intensity of the last four weeks, VASHANOW: Headache Intensity at the moment of testing
VASNP3M Average Neck Pain Intensity of the last three months, VASNPNOW Neck Pain Intensity at the moment of testing; Diff: difference between groups; Prop: proportion
HA: Headache. VAS: 100 mm Visual Analogue Scale (0 mm: no pain; 100 mm: unbearable pain)
*: significant within group difference compared to value at baseline (repeated measures ANOVA, sign. level: p < .05)
UC: Usual Care; UCMT: Usual Care plus Manual Therapy; Diff

ISSN: 1471-2474