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

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.

Keywords: Chronic neck pain; Miniscalpel acupuncture; Non-steroidal anti-inflammatory drugs; Pilot study.

Fig. 1

Flow chart of our pilot randomized controlled trial

Fig. 2

Miniscalpel acupuncture points: (1) below external occipital protuberance, insertion of nuchal ligament, origin of trapezius muscle, upper site of GV16; (2) 2–25.cm side down of external occipital protuberance, rectus capitis posterior major, obliquus capitis superior, GB20; (3) 4–4.5 cm side down of external occipital protuberance, GB12; (4) C2 spinous process, origin of semispinalis capitis, obliquus capitis inferior, rectus capitis posterior major, GV12; (5) side of C2 spinous process, facet joint, BL10; (6) C4 spinous process, origin of semispinalis capitis; (7) C5 spinous process, origin of semispinalis capitis; (8) C6 spinous process, origin of semispinalis capitis; (9) C7 spinous process, GV14; (a) transverse process of atlas, origin of levator scapulae, obliquus capitis superior, obliquus capitis inferior; (b) transverse process of axis, origin of levator scapulae, medial scalene; (c) lamina of C5 (2 cm side of C5 spinous process), splenius capitis, semispinalis capitis; (d) lamina of C6 (2 cm side of C6 spinous process), splenius capitis, semispinalis capitis; (e) GB21, upper trapezius