Efficacy and safety of polydioxanone thread embedded at specific acupoints for non-specific chronic neck pain: a study protocol for a randomized, subject-assessor-blinded, sham-controlled pilot trial

Eunseok Kim, Hye Su Kim, So-Young Jung, Chang Hyun Han, Young-Il Kim, Eunseok Kim, Hye Su Kim, So-Young Jung, Chang Hyun Han, Young-Il Kim

Abstract

Background: This study aims to evaluate the efficacy and safety of thread-embedding acupuncture (TEA) with polydioxanone thread embedded at various acupoints, compared with sham TEA, for the treatment of non-specific chronic neck pain.

Methods/design: This study will be an 8-week-long, two-armed, parallel, randomized, subject-assessor-blinded, sham-controlled pilot trial. Fifty eligible patients will be randomly allocated into the real TEA group or the sham TEA group. The real TEA group will receive TEA treatment at 14 fixed acupoints in the neck region. The sham TEA group will receive the same treatment as the real TEA group, but with a sham device with the thread removed. Both groups will receive treatment once a week for a total of four sessions. The primary outcome will be the mean change in the visual analog scale (VAS) from baseline to week 6 (2 weeks post intervention). Clinical relevance (ratio of the number of patients with decreases on the VAS of ≥15 mm or with percentiles ≥ 30% and ≥ 50% relative to baseline to the total number of patients), Neck Disability Index, pressure pain threshold, the Hospital Anxiety and Depression Scale, EuroQol 5-Dimensions questionnaire, Patient Global Impression of Change, blinding test, and adverse events will be used to assess secondary outcomes.

Discussion: The results of this study will provide valuable data for a large-scale clinical trial to evaluate the clinical effects of polydioxanone TEA in the treatment of patients with non-specific chronic neck pain.

Trial registration: Clinical Research Information Service (CRIS), Republic of Korea, KCT0002452 . Registered on 6 September 2017.

Keywords: Chronic neck pain; Efficacy; Polydioxanone; Randomized sham-controlled trial; Thread-embedding acupuncture.

Conflict of interest statement

Ethics approval and consent to participate

This trial has been approved by the Institutional Review Board (IRB) of Korean Medicine Hospital of Daejeon University (DJDSKH-17-BM-08; March 2017, protocol version 1.2). This study protocol has been designed according to Korean Good Clinical Practices (GCPs) and the Declaration of Helsinki, and has been registered with the Clinical Research Information Service (CRIS) of the National Research Institution of Health in Korea (identifier: KCT0002452), which is recognized as a registry in the World Health Organization’s network. Other important protocol modifications after protocol publication and publication of trial results will be notified through updates on the trial registration site (CRIS). All documents will be identified by an identification code rather than personal information and will be securely stored in a cabinet with locks in the Clinical Trial Center of DKMHDU. Data processing for statistical analyses will be performed by an independent third party and no interim analyses will be conducted.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flowchart of the study
Fig. 2
Fig. 2
Schedule for the treatment and outcome measurements
Fig. 3
Fig. 3
Thread-embedding acupuncture (TEA) device. a: needle used for real TEA. b: needle used for sham TEA (without polydioxanone (PDO) thread)

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