Abstract
BackgroundSciatica is a relatively frequent illness that easily becomes a chronic and relapsing condition. Although numerous systematic reviews have analyzed various therapies for sciatica, the validity of their included studies is limited. Considering the limitations of conventional treatment options for sciatica, acupuncture is a possible option; however, evidence supporting its efficacy and mechanism in patients with sciatica is lacking. The aim of this proposed protocol is to investigate the effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica.Methods/designThis study is a randomized, patient-assessor blind, two-arm, parallel, non-penetrating, sham-controlled clinical trial. Eligible participants will include adults (aged 19–70 years old) with a clinical diagnosis of chronic sciatica (40 mm or more of a 100-mm visual analog scale (VAS) for bothersomeness) blinded to the treatment received. Patients will be randomly allocated into the acupuncture treatment group (manual acupuncture plus electroacupuncture (EA), n = 34) or the sham acupuncture control group (sham acupuncture plus placebo EA without electrical stimulation, n = 34). Groups will receive treatment twice a week for a total of eight sessions over 4 weeks. Functional magnetic resonance imaging will be implemented at baseline and endpoint to investigate the mechanism of acupuncture. The primary outcome measure is the VAS for bothersomeness and secondary outcomes include the VAS for pain intensity, Oswestry Disability Index, EuroQol 5-Dimension, Coping Strategy Questionnaire, Beck’s Depression Inventory, and State-Trait Anxiety Inventory. Adverse events will be assessed at every visit.DiscussionThe results of this trial (which will be available in 2020) should provide important clinical evidence for the effect of acupuncture and demonstrate how acupuncture can be helpful for the treatment of chronic sciatica.Trial registrationClinicalTrials.gov, ID: NCT03350789. Registered on 15 November 2017.
Highlights
Sciatica is a relatively frequent illness that becomes a chronic and relapsing condition
The results of this trial should provide important clinical evidence for the effect of acupuncture and demonstrate how acupuncture can be helpful for the treatment of chronic sciatica
Education on study procedure standardization We developed standard operating procedures (SOPs) for the entire trial and researchers will participate in clinical trial training according to their individual roles based on the Standard operating procedure (SOP)
Summary
Sciatica is a relatively frequent illness that becomes a chronic and relapsing condition. Numerous systematic reviews have analyzed various therapies for sciatica, the validity of their included studies is limited. Considering the limitations of conventional treatment options for sciatica, acupuncture is a possible option; evidence supporting its efficacy and mechanism in patients with sciatica is lacking. The aim of this proposed protocol is to investigate the effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica. Symptoms of sciatic pain are frequent with the highest incidence of 40% and the pain progresses to a chronic and relapsing stage as disturbances anywhere along the course of the sciatic nerve can cause sciatica [4, 5]. Neurophysiological studies for chronic pain are increasingly important, where the pain continues in spite of no stimulation or irritation and the condition is accompanied by changes in neuroplasticity and sensitization of the nervous system [15,16,17,18,19]
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