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

Abstract

Supplemental Digital Content is available in the text

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

“…The detailed process of calculating sample size is described in the protocol paper. 29 All applicants were provided a written explanation and an informed consent form, and received a full explanation of this trial.…”

“…Eligibility criteria were as follows: 14–16 , 29–33 A subject 1) is aged (19–65) years-old, and 2) have suffered from neck pain for over three months, 24 3) scores more than 40 mm on the visual analogue scale (VAS) at the time of screening, 4) is diagnosed with CNP by clinicians based on image examination, history taking, physical and medical examination, and 5) is willing and able to observe the intervention and follow-up assessments. The exclusion criteria were: An excluded subject 1) suffers radicular pain in the upper limb with the distribution of a particular nerve root, 2) demonstrates neurological abnormality, such as positive to special test, such as Bakody sign (shoulder abduction relief sign test), Spurling test, muscle atrophy, paraesthesiae (sensory deficits), hyporeflexia of deep tendon reflex, weakness, pathologic reflex, 3) demonstrates major spinal pathology, such as spondylitis, myelopathy, fracture, neoplasm, neuromyopathic scoliosis, congenital abnormality, 4) shows a history of spinal surgery or scheduled procedures during the study, 5) suffers from pain more severe than neck pain in another region, 6) suffers from uncontrolled low back pain, 31–33 7) shows a history of receiving TEA at the neck region in the past 6 months, 14 8) suffers from skin damage that is difficult to treat on the neck, 9) has shown hypersensitive reaction to previous acupuncture treatment, metal allergy, severe atopy, keloid, or other skin hypersensitivities, 10) suffers from hemorrhagic disease or factors that can affect hemostasis, such as the taking of antiplatelet drug or anti-coagulant, 11) is pregnant, or is planning pregnancy during the trial, 12) suffers from cardiovascular disease or uncontrolled diabetes, 13) shows history of major psychiatric or neurotic disability or cognitive instability, 14) shows history of alcoholism or drug abuse, 15) suffers from severe underlying disease requiring active therapy, or 16) was considered by the researcher to be inappropriate for this trial.…”

“…Detailed information of the intervention and co-interventions is described in the protocol paper. 29 …”

“…The detailed randomization procedure is described in the protocol paper. 29 To reduce bias as much as possible, this trial was designed to be assessor-blinded. The assessor did not perform the intervention, did not know what kind of treatment the subject received, and asked only simple questions about the contents and evaluation items to fill out the case report form (CRF).…”

Acupoint catgut embedding for the treatment of sciatica

“…Our systematic review protocol is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement guidelines. [ 21 ] The systematic review protocol is registered in INPLASY (2020110087;DOI: 10.37766/inplasy2020.11.0087).…”