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 -ChangeV3a–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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 31 participants or records.
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