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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

Efficacy and safety of combined treatment of miniscalpel acupuncture and non-steroidal anti-inflammatory drugs: an assessor-blinded randomized controlled pilot study

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Seungah Jun, Jung Hee Lee, Han Mi Gong, Yeon-Joong Chung, Ju-Ran Kim, Chung A. Park, Seong Hun Choi, Geon-Mok Lee, Hyun-Jong Lee, Jae Soo Kim
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:https://​doi.​org/​10.​1186/​s13063-017-2418-1) contains supplementary material, which is available to authorized users.

Abstract

Background

Chronic neck pain is a common musculoskeletal disease during the lifespan of an individual. With an increase in dependence on computer technology, the prevalence of chronic neck pain is expected to rise and this can lead to socioeconomic problems. We have designed the current pilot study to evaluate the efficacy and safety of miniscalpel acupuncture treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) in patients with chronic neck pain.

Methods

This seven-week clinical trial has been designed as an assessor-blinded, randomized controlled trial with three parallel arms. Thirty-six patients will be recruited and randomly allocated to three treatment groups: miniscalpel acupuncture treatment; NSAIDs; and miniscalpel acupuncture treatment combined with NSAIDs. Patients in the miniscalpel acupuncture and combined treatment groups will receive three sessions of miniscalpel acupuncture over a three-week period. Patients in the NSAIDs and combined treatment groups will receive zaltoprofen (one oral tablet, three times a day for three weeks). Primary and secondary outcomes will be measured at weeks 0 (baseline), 1, 2, 3 (primary end point), and 7 (four weeks after treatment completion) using the visual analogue scale and the Neck Disability Index, EuroQol 5-dimension questionnaire, and Patients’ Global Impression of Change scale, respectively. Adverse events will also be recorded.

Discussion

This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture treatment combined with NSAIDs for chronic neck pain.

Trial registration

Korean Clinical Research Information Service registry, KCT0002258. Registered on 9 March 2017.
Zusatzmaterial
Additional file 1: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents. (DOC 120 kb)
13063_2017_2418_MOESM1_ESM.doc
Additional file 2: Table S1. STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) of experimental group interventions. (DOCX 16 kb)
13063_2017_2418_MOESM2_ESM.docx
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