Effects of a mechanical acupressure needle stimulation pad on chronic low back pain − prospective, single-armed trial

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IntroductionThe needle stimulation mat, also known as fakirs mat or acupressure pad has regularly been advertised as an effective means to reduce chronic back pain, however little is known about the effectiveness of such device. This study aimed to test the effects of the needle stimulation pad for chronic or recurrent low back pain. MethodsIn this prospective, single-armed trial patients with non-specific chronic or recurrent low back pain were selected from a health insurance company database and advised to use the pad daily for two weeks; outcomes were assessed at baseline, weeks 2 and 14. Primary outcome measure was pain intensity at week 2; secondary outcome measures included disability, health-related quality of life, fear avoidance beliefs, analgesic medication and safety. Results91 patients were included (50 males, 52.3±10.5years). No significant differences were found for pain intensity between weeks 0, 2 and 14, however immediate pain relief was detected after the application (p<0.001). Significant decreases were found for disability at weeks 2 (−4.6%,95%CI-6.6;−2.6;p<0.001) and 14 (−4.3,95%CI-6.4;−2.2;p=0.008). For quality of life the physical component summary, physical functioning and vitality changed significantly. Medication consumption significantly decreased. No further changes were observed. Concerning safety, eight patients perceived the intervention as too painful to continue, and one patient reported transient itching and skin reddening after use. ConclusionsThe needle stimulation pad provided immediate non-persistent pain relief in patients with chronic low back pain, but nearly 10% of participants reported adverse reactions discouraging them from further use. Further methodologically rigorous trials are warranted.