Effect and neurophysiological mechanism of acupuncture in patients with chronic sciatica: protocol for a randomized, patient-assessor blind, sham-controlled clinical trial

Koh-Woon Kim, Kyungmo Park, Hi-Joon Park, Geon-Ho Jahng, Dae-Jean Jo, Jae-Heung Cho, Eun-Mo Song, Woo-Chul Shin, Ye-Ji Yoon, Soo-Jeon Kim, Seulgi Eun, Mi-Yeon Song, Koh-Woon Kim, Kyungmo Park, Hi-Joon Park, Geon-Ho Jahng, Dae-Jean Jo, Jae-Heung Cho, Eun-Mo Song, Woo-Chul Shin, Ye-Ji Yoon, Soo-Jeon Kim, Seulgi Eun, Mi-Yeon Song

Abstract

Background: Sciatica 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/design: This 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.

Discussion: The 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 registration: ClinicalTrials.gov, ID: NCT03350789 . Registered on 15 November 2017.

Keywords: Acupuncture; Chronic sciatica; Effect; Functional magnetic resonance imaging.

Conflict of interest statement

Ethics approval and consent to participate

The research protocol was reviewed and approved by the IRB of the Korean Medicine Hospital of Kyung Hee University at Gangdong [KHNMCOH 2017-08-004]. Any important protocol modifications will be made known to relevant parties and/or individuals (e.g., investigators, IRB, trial participants, and funder). The study results will be disseminated in a peer-reviewed medical journal and presented at international conferences. Written informed consent will be obtained from all participants prior to enrollment into the study by the investigator.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The study flow chart
Fig. 2
Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure of enrollment, interventions, and assessments. EA electroacupuncture, VAS visual analog scale, ODI Oswestry Disability Index, EQ-5D EuroQol five-dimensional questionnaire, CSQ Coping Strategy Questionnaire, BDI Beck’s Depression Inventory, STAI State-Trait Anxiety Inventory
Fig. 3
Fig. 3
Functional magnetic resonance imaging experiment paradigm (REST steady-state resting run; TASK 1/2 block design bothersomeness and emotion stimulus run; 3D-T1W structural image acquisition using 3-dimensional T1-weighted turbo field echo; DTI diffusion tensor imaging; TASK 3 low-back-extension pain-model steady-state run)

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