1. Background 
Non-specific neck pain is one of the most common muscloskeletal disease, which follow an episodic course marked by periods of remissions and exacerbations. Thread embedding acupuncture(TEA) is a kind of acupoint embedding therapies. It is thought that continuous stimulation by threads embedded contribute to long-term treatment effect. As the material of the reclaimed yarn, they use the medical suture which is absorbed slowly by the material of catgut in China and the material of Polydioxanone (PDO) in Korea. PDO TEA is expected to have different treatment effect from catgut becaouse of differences in components, resolving time, and interventional procedure. In recent years, clinical studies have been published on the use of Catgut, especially in China, using sham device. However, in our knowledge, there are no high quality randomized sham-controlled clinical trials using PDO in Korea. In this study, we evaluated the efficacy and safety of the PDO TEA with chronic non-specific neck pain compared to Sham-TEA. Adverse effects will also be reported. 

2. Study plan 
 This study will be an equal randomized, two parallel-armed, subject-assessor-blinded, single center, sham controlled pilot trial. A total of 50 participants with chronic non-specific neck pain will be recruited and will be randomized into TEA group or sham TEA group. A total of 4 TEA treatment and 4 sham TEA treatment for local acupoints in neck region will be provided once a week for 4 weeks. Primary end point will be 5 week(2 week after final treatment). VAS(Visual Analogue Scle ; primary outcome measure), Clinical relevance, NDI(Neck Disability Index), PPT(Pressure Pain Threshold), HADS (Hospital anxiety and depression scale), PGIC(Patient Global Impression of change) will be measured. At every visit, researchers will evaluate adverse events (AEs) for safety assessment. 

Treatment

A total of 4 TEA treatment for local acupoints in neck region will be provided once a week for 4 weeks. We will use 29 gauge 25mm or 29 gauge 38mm depending on the general insertion depth for each acupoint. TEA will be conducted on bilateral TE16, LI17, GB21, SI14, GB20, C5 and C7 EX-B2. Sham TEA group is treated in the same manner using the Sham device(needle removed PDO thread).

Arm Label

Target Number of Participant

Arm Type

Arm Description

A total of 4 TEA treatment for local acupoints in neck region will be provided once a week for 4 weeks. We will use 29 gauge 25mm or 29 gauge 38mm depending on the general insertion depth for each acupoint. TEA will be conducted on bilateral TE16, LI17, GB21, SI14, GB20, C5 and C7 EX-B2. 

Arm Label

Target Number of Participant

Arm Type

Arm Description

Sham TEA group is treated in the same manner as the TEA group using the Sham device(needle removed PDO thread).

Gender

Age

Description

1. Age of 19-65 years 
2. Suffering from neck pain over 3 months 
3. More than 40mm on VAS(Visual Analogue Scale) at the time of screening 
4. Diagnosis of non-specific neck pain by clinicians based on history taking, physical examination, image examinationm, and medical examination 
5. Able and willing to comply with the intervention and follow-up evaluation 
6. Able to provide written informed consent   

1. radicular pain in the upper extremity with the distribution of a particular nerve root 
2. neurological abnormality as follows 
 ① weakness, paraesthesiae(sensory deficits) 
 ② Special test: Spurling test, Shoulder abduction relief sign test(Bakody sign) 
 ③ Hyporeflexia of DTR(Deep Tendon Reflex) 
 ④ Pathologic reflex : Hoffman sign, Babinski sign, Ankle clonus 
 ⑤ muscle atrophy: Deltoid, Biceps, Triceps, Hand intrinsic m. 
3. Major spinal pathology such as myelopathy, spondylitis, neoplasm, fracture, congenital abnormality, neuromyopathic scoliosis 
4. History of spinal surgery or scheduled procedures during the study 
5. Suffering from pain in another region that is greater than the neck pain 
6. Uncontrolled low back pain 
7. History of TEA treatment 
8. Hypersensitive reaction to previous acupuncture treatment, metal allergy, severe atopy, keloid, and other skin hypersensitivities 
9. Hemorrhagic disease and/or factors that can affect hemostasis, such as anti-coagulant or anti-platelet drug use 
10. Pregnancy, lactation, or a plan to become pregnant during childbearing years 
11. Uncontrolled diabetes, or Cardiovascular disease 
12. History of neurotic or major psychiatric disability or cognitive instability 
13. History of alcoholism or drug abuse 
14. Severe underlying disease requiring active therapy 
15. Patients who are considered to be inappropriate for the study by the researcher 

VAS(Visual Analogue Scale)

0 week(baseline), 2 week, 5 week, 7 week 

Safety assessment(Adverse effect) 

every visit 

NDI(Neck Disability Index)

0 week(baseline), 2 week, 5 week, 7 week 

Clinical relevance(MCID ratio) 

0 week(baseline), 2 week, 5 week, 7 week 

PPT (Pressure Pain Threshold) 

0 week(baseline), 2 week, 5 week, 7 week 

HADS (Hospital anxiety and depression scale) 

0 week(baseline), 2 week, 5 week, 7 week 

EQ-5D(EuroQol) 

0 week(baseline), 2 week, 5 week, 7 week 

PGIC(Patient Global Impression of change)

5 week, 7 week 

Blinding test

0 week(baseline), 3 week