Integrative TCM Conservative Therapy for Low Back Pain due to Lumbar Disc Herniation: A Randomized Controlled Clinical Trial

Table 2

Changes in primary and secondary outcomes*.

Variable	Outcomes of different timepoints (means ± SD)^▾		Mean change from baseline (95% CI)		Between-group difference (95% CI)	𝑃 value§
	Experimental group; (𝑁=306)	Control group; (𝑁=102)	Experimental group; (𝑁=306)	Control group; (𝑁=102)	Experimental group versus control group
VAS scores^※
M1	53.94 ± 19.60	56.00 ± 19.61	—	—	—	0.358
M2	24.48 ± 17.73	43.16 ± 20.75	−29.46 (−31.52 to −27.40)	−12.84 (−15.58 to −9.83)	−16.62 (−20.25 to −12.98)	<0.001
M3	7.40 ± 6.52	15.83 ± 11.61	−46.54 (−48.50 to −44.57)	−40.17 (−43.26 to −37.07)	−6.37 (−10.20 to −2.54)	0.001
M4	2.32 ± 2.29	7.94 ± 6.76	−51.62 (−53.73 to −49.51)	−48.06 (−51.45 to −44.67)	−3.56 (−7.69 to 0.57)	0.091
C-SFODI^†
M1	46.07 ± 20.56	49.59 ± 22.53	—	—	—	0.145
M2	20.20 ± 13.79	39.26 ± 22.84	−25.88 (−27.70 to −24.05)	−10.33 (−13.17 to −7.48)	−15.55 (−18.92 to −12.18)	<0.001
M3	6.69 ± 5.98	21.57 ± 15.35	−39.38 (−41.33 to −37.44)	−28.02 (−30.64 to −25.39)	−11.37 (−14.62 to −8.11)	<0.001
M4	2.16 ± 2.01	13.36 ± 10.64	−43.91 (−46.07 to −41.75)	−36.23 (−39.30 to −33.16)	−7.68 (−11.42 to −3.94)	<0.001

∗Values are means with means ± SD or the 95% confidence (CI). M1: measurements were obtained at baseline; M2: immediately after the last intervention; M3: one month after the last intervention; M4: six months after the last intervention.
^▾The VAS scores means at different timepoints between two groups were analyzed by repeated measures analysis of variance. Within-subjects effects tests of different timepoints means, 𝐹=1381.914, 𝑃<0.001. Between-subjects effects tests of different group means, 𝐹=46.322, 𝑃<0.001. The C-SFODI means at different timepoints between two groups were analyzed by repeated measures analysis of variance. Within-subjects effects tests of different timepoints means, 𝐹=1076.327, 𝑃<0.001. Between-subjects effects tests of different group means, 𝐹=78.879, 𝑃<0.001.
^§𝑃 values were calculated with independent-samples 𝑡-test for mean change from baseline between two groups.
^※Visual analogue scale (VAS, scores range 0 to 100) with higher scores indicating greater pain.
^†The Chinese Short Form Oswestry Disability Index (C-SFODI, range 0 to 100%) consists of 9 questions, with higher percentage indicating more severe functional disability.