Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial

Cogné, Mélanie; Petit, Hervé; Creuzé, Alexandre; Liguoro, Dominique; de Seze, Mathieu

doi:10.1186/s12891-017-1816-6

Table 2 Presentation of averages, standard deviations and p-values of judgment criteria for group A and group B

From: Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial

		Number of patients (n) A/B	Mean group A	Standard deviation group A	Mean group B	Standard deviation group B	p-value
Average lumbar pain over last 8 days by visual analogue scale (/100 mm)	D0	18/19	67.70	24.64	60.35	28.07	p = 0.43
	D30	18/19	63.12	18.92	63.12	18.92	p = 0.75
	D90	15/16	62.60	27.39	58.43	24.66	p = 0.80
	D120	15/16	60.87	26.83	55.87	32.50	p = 0.70
Average root pain over last month by visual analogue scale (/100 mm)	D30	18/19	60.29	22.99	53.47	33.88	p = 0.45
	D90	15/16	42.07	37.40	27.57	33.05	p = 0.52
	D120	15/16	56.73	25.33	46.20	30.42	p = 0.70
Number of days with significant or very significant pain	D30	18/19	13.29	9.88	15.18	12.82	p = 0.55
Number of days with significant or very significant pain	D90	15/16	11.43	10.45	11.71	16.94	p = 0.44
Functional disability related to low-back pain by Quebec Back Pain Disability Scale (/100)	D0	18/19	51.53	16.19	52.35	20.16	p = 0.89
	D30	18/19	53.76	13.18	52.29	20.74	p = 0.77
	D90	15/16	53.07	17.75	45.93	22.82	p = 0.47
	D120	16/16	52.87	21.69	42.93	23.70	p = 0.48
Inability to work during last 30 days (/30)	D0	18/19	11.00	14.56	11.06	14.55	p = 0.99
	D30	18/18	12.41	15.17	9.56	14.25	p = 0.35
	D90	15/16	12.41	14.59	9.69	17.93	p = 0.46
	D120	15/16	8.00	13.73	12.00	15.21	p = 0.34
Estimated impact of low-back pain on quality of life (/100)	D0	18/19	71.41	21.70	64.47	24.61	p = 0.37
	D30	18/19	68.71	18.85	64.06	23.33	p = 0.44
	D90	15/16	63.47	23.72	58.57	23.33	p = 0.38
	D120	15/16	61.00	30.01	60.67	29.63	p = 0.96
Number of days when pain medication or anti-inflammatories were necessary in last 30 days (/30)	D0	18/19	17.06	13.65	15.35	14.69	p = 0.71
	D30	18/19	16.06	13.21	13.41	13.44	p = 0.51
	D90	15/16	15.73	13.85	11.50	13.82	p = 0.79
	D120	15/16	14.80	14.87	13.53	14.54	p = 0.86
Patients’ assessment of efficacy of treatment (/100)	D30	18/19	0.76	1.15	0.94	1.14	p = 0.62
	D90	15/16	1.33	1.80	1.43	1.60	p = 1.00
	D120	15/16	1.47	1.77	1.73	1.62	p = 1.00
Spinal flexibility measured by Schoeber Macrae’s test (cm)	D0	18/19	5.00	2.34	4.21	1.86	p = 0.22
	D30	18/19	4.76	1.88	4.32	1.67	p = 0.48
	D90	15/16	4.00	1.18	4.54	1.31	p = 0.23
	D120	15/16	4.23	1.55	5.53	2.28	p = 0.18
Hand-ground distance (cm)	D0	18/19	26.17	13.32	25.64	14.03	p = 0.93
	D30	18/19	26.35	14.02	26.85	12.89	p = 0.92
	D90	15/16	24.87	14.51	16.79	10.17	p = 0.35
	D120	15/16	27.53	12.18	21.93	13.08	p = 0.25
Isokinetic maximum strength (n/m)	D0	16/17	116.00	45.53	126.40	63.41	p = 0.78
	D30	15/18	120.93	53.30	134.40	63.67	p = 0.70
	D120	13/14	126.69	67.20	135.07	50.35	p = 0.70
Isokinetic endurance (n/m)	D0	16/17	100.27	51.63	102.33	63.24	p = 0.81
	D30	15/17	96.07	53.38	108.73	69.00	p = 0.76
	D120	15/14	103.17	63.74	111.79	57.67	p = 0.65
Isokinetic maximum force ratio flexors/extensors (%)	D0	16/17	115.85	31.13	119.72	38.95	p = 0.36
	D30	15/17	122.93	33.83	107.86	24.41	p = 0.16
	D120	13/14	111.54	24.29	102.88	23.53	p = 0.72

Group A: all 17 patients assessed during 120 days after BoNT-A injections, group B: all 17 patients assessed during 120 days after placebo injections

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