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

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.

SUBMITTER: Kim KW

PROVIDER: S-EPMC6335765 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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

Kim Koh-Woon KW Park Kyungmo K Park Hi-Joon HJ Jahng Geon-Ho GH Jo Dae-Jean DJ Cho Jae-Heung JH Song Eun-Mo EM Shin Woo-Chul WC Yoon Ye-Ji YJ Kim Soo-Jeon SJ Eun Seulgi S Song Mi-Yeon MY

Trials 20190116 1

<h4>Background</h4>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 invest ...[more]

PMID: 30651139

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Project description:Chronic neck pain (CNP) is a common painful medical condition with a significant socioeconomic impact. In spite of widespread usage, the effectiveness and safety of combined treatments between conventional and complementary alternative medical treatment modalities has not been fully established in a rigorous randomized clinical trial (RCT). This pilot study will provide the clinical evidence to evaluate the feasibility and refine the protocol for a full-scale RCT on combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) in patients with CNP.This is a randomized, single-blind clinical trial with three parallel arms. Sixty patients between 18 and 65 years of age with non-specific, uncomplicated neck pain lasting for at least three months will be enrolled. Participants will be randomly allocated into the BVA, NSAIDs or combined treatment group. Assessors and statisticians will be blinded to the random allocation. All researchers will receive training to ensure their strict adherence to the study protocol. Patients from the BVA and combined treatment group will be treated with a bee venom increment protocol into predefined acupoints for six sessions over a three week period. BVA intervention is developed through a comprehensive discussion among interdisciplinary spine disorder experts, according to the guidelines of Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). Patients from the NSAIDs and combined treatment groups will be prescribed loxoprofen (one tablet to be taken orally, three times a day for three weeks). Bothersomeness from CNP measured using a visual analogue scale (VAS) will be the primary outcome assessed at screening, visit two (baseline), four, six, eight (4th week assessment) and nine (8th week assessment) follow-up session. VAS for pain intensity, neck disability index (NDI), quality of life, depressive status and adverse experiences will also be analyzed.Our study results will contribute to feasibility evaluation and to relevant RCT protocol development for a full-scale RCT on combined treatment of BVA and NSAIDs for CNP patients.This study is registered with the United States (US) National Institutes of Health Clinical Trials Registry: NCT01922466.

Project description:BackgroundBell's palsy is the most frequent cause of unilateral peripheral facial palsy, a common condition that third of patients can have inadequate recovery and subsequent physical and social impairments. The largely ineffective and even controversial nature of the various medical and surgical treatment options means that novel, alternative approaches are needed. In preclinical and clinical evidence, low-level laser therapy (LLLT) has demonstrated the ability to regenerate peripheral nerves. Laser acupuncture treatment (LAT), the stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation, is a common treatment modality, but its efficacy in chronic Bell's palsy is undetermined. This study aims to evaluate the efficacy of LAT in patients experiencing inadequate recovery from Bell's palsy.MethodsThis 2-armed, parallel, randomized, subject-assessor-blinded, single-center, sham-controlled pilot trial will randomly assign 32 eligible patients into either a real LAT group (n = 16) or a sham LAT group (n = 16). The real LAT group will receive 3 LAT sessions each week for 6 weeks (a total of 18 sessions), delivered to acupoints corresponding with the affected side of the face. The sham LAT group will receive the same treatment as the real LAT group, but with a sham laser device. The primary outcome measure will be the change from baseline at week 6 in the Facial Disability Index score. Secondary outcomes will monitor changes during treatment in the House-Brackmann and Sunnybrook facial nerve grading systems and stiffness scale, at weeks 1, 3, and 6.DiscussionTo the best of our knowledge, this double-blind, randomized, sham-controlled trial is the first such investigation into the efficacy of LAT in chronic Bell's palsy. Clinical trials using LLLT have shown positive therapeutic effects in acute Bell's palsy, although as yet, the feasibility and efficacy of LAT remain unclear in patients experiencing inadequate recovery from Bell's palsy.Trial registrationThis trial protocol has been approved by the Research Ethics Committee of the China Medical University Hospital, Taichung, Taiwan (Protocol ID: CMUH107-REC1-030) also registered at ClinicalTrials.gov (identifier no. NCT03592797).

Dataset Information

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

Publications

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

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