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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

A multi-center, randomized controlled clinical trial, cost-effectiveness and qualitative research of electroacupuncture with usual care for patients with non-acute pain after back surgery: study protocol for a randomized controlled trial

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Byung-Cheul Shin, Jae-Heung Cho, In-Hyuk Ha, In Heo, Jun-Hwan Lee, Koh-Woon Kim, Me-riong Kim, So-Young Jung, Ojin Kwon, Nam-Kwen Kim, Haeng-Mi Son, Dong-Wuk Son, Kyung-Min Shin
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2461-6) contains supplementary material, which is available to authorized users.

Abstract

Background

Although pain after back surgery is known to be difficult to control, various treatment options are available to patients and physicians. A protocol for a confirmatory randomized controlled trial (RCT) on pain and function after back surgery was designed based on the results of a pilot trial. The aim of this study is to compare the effectiveness and safety of electroacupuncture (EA) with usual care (UC) versus UC alone on pain control and functional improvement after back surgery.

Methods/design

This study is a multi-center, randomized, assessor-blinded trial with an active control conducted in conjunction with a cost-effectiveness analysis and qualitative research. Participants with non-acute low back pain with or without leg pain after back surgery who have a Visual Analogue Scale (VAS) pain intensity score ≥ 50 mm will be randomly assigned to either the EA with UC group (n = 54) or the UC group (n = 54). Following randomization, participants in both groups will receive the same UC treatment twice a week for a four-week treatment period. Participants assigned to the EA with UC group will additionally receive EA twice a week for the same four-week period. The primary outcome measure will be assessed using a VAS pain intensity score for low back pain. The secondary outcomes will include the Oswestry Disability Index, EuroQol 5-Dimension score, and drug intake. The primary and secondary outcomes will be measured at one, four, and eight weeks post randomization.

Discussion

The results of this study will provide evidence of the effectiveness and cost-effectiveness of EA in managing postoperative pain following back surgery. In addition, the qualitative research results will help improve the quality of integrative medical interventions.

Trial registration

Clinical Research Information Service (CRIS), Republic of Korea, KCT0001939. Registered on 8 June 2016.
Zusatzmaterial
Additional file 1: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA). (DOCX 24 kb)
13063_2018_2461_MOESM1_ESM.docx
Additional file 2: SPIRIT 2013 checklist. (DOC 137 kb)
13063_2018_2461_MOESM2_ESM.doc
Literatur
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