• J Altern Complement Med · Apr 2019

    Randomized Controlled Trial

    Effectiveness and Safety of Polydioxanone Thread-Embedding Acupuncture as an Adjunctive Therapy for Patients with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial.

    • Eunseok Kim, Yong-Suk Kim, Young Il Kim, Ju-Hyun Jeon, Ho-Ryong Yoo, Yang-Chun Park, and In Chul Jung.
    • 1 Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, Daejeon University , Daejeon, Republic of Korea.
    • J Altern Complement Med. 2019 Apr 1; 25 (4): 417-426.

    ObjectiveTo evaluate the effectiveness and safety of treatment with thread-embedding acupuncture (TEA) using polydioxanone in addition to usual care for patients with chronic nonspecific neck pain (CNP) compared with treatment with usual care alone.MethodsA single-center, assessor-blinded, two-armed randomized controlled trial was performed. One hundred and six outpatients with CNP were randomly allocated into the TEA plus usual care (TU) group or the usual care (UC) group in a 1:1 ratio. TEA treatments in the neck region were provided once a week for 4 weeks, and usual care, as needed, was allowed. The primary outcome was the mean Neck Pain and Disability Scale (NPDS) score. Secondary outcomes included clinical relevance measured by using the clinically important difference (CID), pressure pain threshold (PPT), Hospital Anxiety and Depression Scale (HADS), EuroQol-5 Dimension (EQ-5D), and patient global impression of change (PGIC). Participants were assessed at baseline and at weeks 3, 5, and 9. Statistical analyses included analysis of covariance with baseline score as a covariate.ResultsThe TU group showed significant improvement in NPDS scores compared with the UC group (adjusted group difference, week 5: 13.74 [95% confidence interval: 7.57-19.90]; p < 0.0001 and week 9: 17.46 [11.15-23.76]; p < 0.0001). The proportion of patients with a decrease on the NPDS score of ≥11.5 points (minimal CID) was significantly higher in the TU group at weeks 5 and 9 than in the UC group. At weeks 5 and 9, significant differences were observed on the anxiety/depression subscale of HADS, EQ-5D, and PGIC between the two groups, but not the PPTs at three sites. Temporary stiffness was observed after TEA treatment, but no serious adverse events occurred.ConclusionsThe results suggest that polydioxanone TEA is a safe and clinically beneficial adjunctive treatment for patients with CNP.

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