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

Abstract

Background Thread embedding acupuncture (TEA) has recently been used as a conservative treatment method for non-specific chronic neck pain (CNP). The objective of this study was to evaluate the effectiveness and safety of TEA compared to physical therapy (PT) for treating patients with CNP. Methods A total of 128 patients diagnosed with CNP were randomly assigned to a TEA group and a PT group at a 1:1 ratio. The TEA group received four sessions of TEA, while the PT group received eight sessions of PT over 4 weeks. Outcomes were assessed using Neck Pain and Disability Scale (NPDS), clinically important difference (CID), cervical spinal angle, Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Patient Global Impression of Change (PGIC), and EuroQol Five-Dimension (EQ-5D) at baseline and 5, 9, and 13 weeks. Results The TEA group showed significant improvement in NPDS compared to the PT group at 5, 9, and 13 weeks. Proportions of patients with decreased NPDS scores of more than 11.5 points (minimal CID) were significantly higher in the TEA group at 5, 9, and 13 weeks. There were significant differences between the two groups at 5, 9, and 13 weeks for BDI-II, and at 5 and 9 weeks for BAI. For EQ-5D, the TEA group showed significant improvement at 5, 9, and 13 weeks. There was no significant difference in cervical spinal angle between the two groups. For PGIC, better improvement was observed at 9 and 13 weeks in the TEA group. Adverse events associated with interventions were mostly temporary and mild. Conclusion For patients with CNP, TEA treatment was found to be more effective than PT treatment for improving their pain and dysfunction, quality of life, and psychological distress. Despite some post-treatment discomfort, TEA treatment can be considered as a useful treatment method for patients with CNP. Trial Registration This trial has been registered 5 April 2019 in Clinical Research Information Service of South Korea (CRIS- KCT0003720).

Thread Embedded Acupuncture for Non-Specific Posterior Neck Pain: A PRISMA-Compliant Protocol for Systematic Review and Meta-Analysis

“…Kim et al 15 and Chu et al 16 conducted RCTs and reported that TEA was not associated with serious side effects of TEA and that it significantly improved the quality of life of patients. Kim et al 26 reported that there was a significant improvement of pain relief in TEA compared to that with conventional physical therapy. However, they reported one case of pneumothorax.…”

Adverse Events of Thread Embedding Acupuncture for the Musculoskeletal Conditions and Diseases: A Narrative Review of Clinical Studies

“…Therefore, when designing TEA clinical trials, the proportion of individualized embedding points could be increased using the acupoint pool, which the practitioners chose according to the patient's symptoms, and reduce the number of fixed embedding points to obtain an appropriate level of stimulation. This strategy was confirmed by the proportion of patients who reported AEs, which was reduced from 22.6% to 17.2% [25].…”

“…The musculoskeletal conditions/diseases in the included 22 clinical studies were lumbar disc herniation (5 studies, 22.7%) [12][13][14][15][16], cervical spondylotic radiculopathy (4 studies, 18.2%) [17][18][19][20], chronic low back pain (3 studies, 13.6%) [21][22][23], chronic neck pain (3 studies, 13.6%) [24][25][26], ankylosing spondylitis (2 studies, 9.1%) [27,28], rheumatoid arthritis (2 studies, 9.1%) [29,30], and other conditions/diseases (3 studies, 13.6% each) such as acute adhesive capsulitis [31], primary restless legs syndrome [32], and Duchenne muscular dystrophy [33]. There were 10 studies in which TEA was applied as a single intervention in the experimental group, and 11 studies in which TEA was used in a combined intervention, such as adjuvant or synergistic therapy.…”

“…In future clinical research, all AEs should be collected and analyzed so that the clinical course post-TEA treatment can be studied, which will provide useful information on the expected course of AEs to both, the patient, and the practitioner. For example, Feng et al [39] reported the course of an AE over time, and Kim et al [24] and Kim et al [25] reported the duration of each AE.…”

Thread-Embedding Acupuncture for the Treatment of Shoulder Instability: Protocol for a Randomized, Controlled, Patient-Assessor Blinded Pilot Study

“…Based on these improvements in safety, TEA has been used for the treatment of a wide range of diseases including obesity, rhinitis, facial paralysis, 15 and several conditions of musculoskeletal pain. [16][17][18][19] Furthermore, for the purposes of long-term pain management and functional improvement, many studies on TEA treatment for shoulder diseases have shown considerable clinical effects for frozen shoulder, 20 periarthritis, 21 and rotator cuff syndrome; 22 however, there has been no clinical study on the effect of TEA on shoulder instability.…”