Efficacy and safety of thermobalancing therapy with Dr Allen’s Device for chronic low back pain: A randomised controlled trial

Table 1 Patient characteristics and correlation analysis

Characteristic	Treatment group	Correlation coefficient (r)	Control group	Correlation coefficient (r)
Number of patients (n)	40		15
Age (mean ± SD)	42.2 ± 8.49	-0.1124a; 0.099b	38.06 ± 5.98	0.4919a; 0.045b
Gender (M:F)	18:22	0.2353a; -0.08b	11:4	0.1183a; -0.34b
NSLBP:LDH	1:1	-0.131a; 0.126b	7:8	0.1396a; 0.172b
NPRS – how would you rate your pain right now?	6.48 ± 1.63		8.07 ± 1.16
JOABPEQ – low back pain	8.9 ± 14.38		10.40 ± 12.66

^aCorrelation analysis with initial NPRS (How would you rate your pain right now?) score.

^bCorrelation analysis with initial JOABPEQ (Low back pain) score.

NSLBP: Non-specific low back pain; LDH: Lumbar disc herniation; NPRS: Numerical Pain Rating Scale; JOABPEQ: The Japanese Orthopedic Association Back Pain Evaluation Questionnaire.

Table 2 Comparison of Numerical Pain Rating Scale scores before and after Thermobalancing therapy with Dr Allen’s Device

	NPRS parameters	Initial (mean ± SD)	1 mo (mean ± SD)		3 mo (mean ± SD)	P value (0-3 mo)
Treatment group	How would you rate your pain RIGHT NOW	6.48 ± 1.63	4.63 ± 1.00		3.18 ± 1.87	< 0.001
	P value	< 0.001a		< 0.001b
	USUAL level of pain during the last week	6.35 ± 1.23	4.18 ± 0.96		3.0 ± 1.43	< 0.001
	P value	< 0.001a		< 0.001b
	BEST level of pain during the last week	5.78 ± 1.25	3.78 ± 0.97		2.18 ± 1.62	< 0.001
	P value	< 0.001a		< 0.001b
	WORST level of pain during the last week	7.9 ± 1.50	4.93 ± 1.10		3.6 ± 2.01	< 0.001
	P value	< 0.001a		< 0.001b
Control group	How would you rate your pain RIGHT NOW	8.07 ± 1.16	8.4 ± 0.63		8.47 ± 0.64	> 0.05
	P value	> 0.05a		> 0.05b
	USUAL level of pain during the last week	7.53 ± 0.92	8.13 ± 0.52		8.67 ± 0.49	> 0.05
	P value	> 0.05a		> 0.05b
	BEST level of pain during the last week	7.33 ± 0.98	7.87 ± 0.64		8.13 ± 0.74	> 0.05
	P value	> 0.05a		> 0.05b
	WORST level of pain during the last week	8.73 ± 1.10	8.67 ± 0.49		9.00 ± 0.38	> 0.05
	P value	> 0.05a		> 0.05b

^aP value comparing NPRS score at 0 and 1 mo.

^bP value comparing NPRS score at 1 and 3 mo.

NPRS: Numerical Pain Rating Scale; SD: Standard deviation.

Table 3 Comparison of the Japanese Orthopedic Association Back Pain Evaluation Questionnaire (JOABPEQ) functional domains before and after Thermobalancing therapy with Dr Allen’s Device

	JOABPEQ functional domains	Initial evaluation	Final evaluation	Difference	P value
Treatment group	Low back pain	8.9 ± 14.38	75.05 ± 20.97	66.15	< 0.001
	Lumbar function	20.08 ± 18.24	60.25 ± 18.38	40.17	< 0.001
	Walking ability	23.38 ± 19.09	55.73 ± 21.07	32.35	< 0.001
	Social life function	19.83 ± 14.02	55.50 ± 17.37	35.67	< 0.001
	Mental health	31.78 ± 20.85	67.35 ± 13.83	35.57	< 0.001
Control group	Low back pain	10.40 ± 12.66	6.67 ± 13.13	-3.73	0.29
	Lumbar function	39.40 ± 25.57	17.73 ± 14.69	-21.67	0.01
	Walking ability	23.80 ± 30.96	14.20 ± 16.01	-9.6	0.69
	Social life function	33.07 ± 24.10	13.87 ± 9.24	-19.2	0.01
	Mental health	31.93 ± 19.76	12.80 ± 6.83	-19.13	< 0.001

JOABPEQ: The Japanese Orthopedic Association Back Pain Evaluation Questionnaire.