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

Abstract

BackgroundThis 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/designThis 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.DiscussionThe 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 registrationClinical Research Information Service (CRIS), Republic of Korea, KCT0002452. Registered on 6 September 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-3058-9) contains supplementary material, which is available to authorized users.

Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture Compared to Physical Therapy in the Treatment of Patients with Non-Specific Chronic Neck Pain: An Assessor-Blinded, Randomized, Controlled, Clinical Trial

“…TEA was administered once weekly, whereas PT twice weekly because this study focused on verifying external validity based on actual clinical practice as well as treatment frequency of TEA and PT in previous studies. 15 , 16 , 57 Nevertheless, it was noteworthy that fewer sessions of TEA yielded better outcomes than PT. The therapeutic mechanism of TEA has yet to be clearly established; however, it is suggested that long-lasting stimulation of afferent fibers by embedded PDO threads contributes to pain relief.…”

Effectiveness and safety of polydioxanone thread embedding acupuncture compared to physical therapy in the treatment of patients with non-specific chronic neck pain

“…This trial is designed to compare the clinical effectiveness and safety of TEA with that of PT in the treatment of patients with CNP. Although TEA treatment studies for CNP have been reported, [14,15] to the best of our knowledge, no RCT investigating the effectiveness and safety of the TEA treatment compared with PT in the treatment of patients with CNP has been reported. Therefore in this trial, we will set the PT group as a control group to evaluate the differences in therapeutic effects caused by the TEA.…”

“…This study is to recruit 128 applicants, who meet the criteria of inclusion and exclusion (Table 1). [14,15,21] A total of 128 patients with CNP are to be recruited from Daejeon University Dunsan Korean Medicine Hospital. Applicants will be recruited through advertisements posted on bulletin boards at hospitals, subway stations, apartments, subway cars, hospital homepages, newspapers, etc.…”

“…[11–13] In the Republic of Korea, studies of Polydioxanone (PDO) TEA, which is mainly used in Korea, have been carried out. Studies that applied PDO TEA to CNP include studies on the effectiveness and safety of TEA and Sham TEA, [14] and the comparison of TEA plus usual care to usual care. [15]…”

Efficacy and safety of thread embedding acupuncture on knee osteoarthritis

“…[ 11 ] Thread embedding treatment maximizes stimulation by inserting embedded threads into the acupoint, percutaneous layer, superficial muscles, meridian system, or areas that induce pain by means of needle retention action. [ 12 ] In addition, it activates the meridian system, supply nutrients to muscles and peripheral nerves, and strengthening cell immunity. [ 13 , 14 ]…”