Electromagnetic Induction for Treatment of Unspecific Back Pain: A Prospective Randomized Sham-Controlled Clinical Trial

Abstract

Objective: To evaluate the effects of high-energy pulsed electromagnetic fields on unspecific back pain.

Methods: A prospective, randomized, sham-controlled clinical trial with repeated measurements was performed. The study included 5 visits (V0 to V4) with 3 interventions during V1, V2 and V3. Sixty-one patients aged between 18 and 80 years with unspecific back pain (acute inflammatory diseases and specific causes were reasons for exclusion) were included. The treatment group (n = 31) received 1-2 pulses/s, with an intensity of 50 mT, and an electric field strength of at least 20 V/m on 3 consecutive weekdays for 10 min each time. The control group (n = 30) received a comparable sham therapy. Pain intensity (visual analogue scale), local oxyhaemoglobin saturation, heart rate, blood pressure, and perfusion index were evaluated before (b) and after (a) V1 and V3 interventions. Change in visual analogue scale for V1 (ChangeV1a-b) and V3 (ChangeV3a-b), and ChangeData between V3a and V1b (ChangeV3a-V1b) for the remaining data were calculated (results were mean (standard deviation) (95% confidence interval; 95% CI)).

Results: Concerning the visual analogue scale: (i) compared with the control group, the treatment group had higher ChangeV1a-b (-1.25 (1.76) (95% CI -1.91 to -0.59) vs -2.69 (1.74) (95% CI -3.33 to -2.06), respectively), and comparable Change V3a-b (-0.86 (1.34) (95% CI -1.36 to -0.36) vs -1.37 (1.03) (95% CI -1.75 to 0.99), respectively); and (ii) there was a significant marked decrease in Change V3a-1b in the treatment group compared with the control group (-5.15 (1.56) (95% CI -5.72 to -4.57) vs -2.58 (1.68) (95% CI -3.21 to -1.96), p = 0.001, respectively). There was no significant ChangeV3a-V1b in local oxyhaemoglobin saturation, heart rate, blood pressure or perfusion index between the 2 groups and for the same group (before vs after).

Conclusion: Non-thermal, non-invasive electromagnetic induction therapy had a significant and rapid influence on unspecific back pain in the treatment group.

Fig. 1

Study flow chart. CG: control group; TG: treatment group.

Fig. 2

Therapeutic magnetic pulse generator device (PAPIMI-SERIES, Type: ASCLIPIOS; Athens, Greece; User Manuals Version 23 2015).

Fig. 3

Typical body position and techniques for the application of electromagnetic induction’s in patients with back pain. (A) Upper back. (B) Middle back. (C) Lower back.

Fig. 4

Pain (visual analogue scale; VAS), at (A) the first intervention (V₁), (B) the third intervention (V₃), and (C) between “before V1 (V_1b)” and “after V3 (V_3a)” of the treatment (n = 31) and control (n = 30) groups. V_1a: after the first intervention; V_1b: before the first intervention; V_3a:after the third intervention; V_3b: before the third intervention. Change_V1a–b = value at V_1a minus value at V_1b. Change_V3a–b = value at V_3a minus value at V_3b. Change_V3a–V1b = value at V_3a minus value at V_1b. Data were mean (95% confidence interval; 95% CI). p-values: Student t-test. ^*< 0.05: comparison before (_b) vs after (_a) (V_1b vs V_1a; V_3b vs V_3a; V_3a vs V_1b) for the same group. ^¥< 0.05: comparison for the same intervention (Change_V1a–b or Change_V3a–b) between the 2 groups. ^#< 0.05: comparison of Change_V3a–V1b between the 2 groups.