Skip to content

  • About CRIS
  • Search
    • Basic Search
    • Advanced Search
    • Search by Topics
      • Condition(s)/Problem(s)
      • Intervention Type
      • Phase
    • Recently Registered
    • Recently Updated
  • FAQ
  • Statistics
  • Registration Data Set

Contact Us

criskorea@korea.kr
Background Information
1.Background  
CRIS Registration Number KCT0002452 
Unique Protocol ID K17760 
Public/Brief Title Efficacy and safety of Thread Embedded for Chronic Neck Pain 
Scientific Title Efficacy and safety of Polydioxanone Thread Embedded for Chronic Non-specific Neck Pain : a randomized, subject-assessor-blinded, sham controlled pilot trial  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number DJDSKH-17-BM-08 
Approval Date 2017-05-19 
Institutional Review Board  
- Name Institutional Review Board, Korean Medicine Hospital of Daejeon University  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Young Il Kim 
- Title professor 
- Telephone +82-42-470-9137 
- Affiliation Dunsan Korean Medicine Hospital of Daejeon University 
- Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea 
Contact Person for Public Queries
- Name Eunseok Kim 
- Title fellow staff 
- Telephone +82-42-470-9140 
- Affiliation Dunsan Korean Medicine Hospital of Daejeon University 
- Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea 
Contact Person for Updating Information
- Name Hye su Kim 
- Title resident 
- Telephone +82-42-470-9137 
- Affiliation Dunsan Korean Medicine Hospital of Daejeon University 
- Address 75, Daedeok-daero 176beon-gil, Seo-gu, Daejeon, Republic of Korea 
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2017-05-30 , Actual
Target Number of Participant 50
Primary Completion Date 2017-12-31 , Anticipated
Study Completion Date 2017-12-31 , Anticipated
Recruitment Status by Participating Study Site 1 
- Name of Study Site Dunsan Korean Medicine Hospital of Daejeon University 
- Recruitment Status Recruiting  
- Date of First Enrollment 2017-05-30 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Korea Institute of Oriental Medicine 
- Organization Type Others  
- Project ID K17760 
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Dunsan Korean Medicine Hospital of Daejeon University 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
Lay Summary 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.  
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Single 
Blinded Subject Subject 
Allocation RCT 
Intervention Type Others (Thread Embedding Acupuncture)
Intervention 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. Sham TEA group is treated in the same manner using the Sham device(needle removed PDO thread).  
Number of Arms
Arm 1 Arm Label TEA group 
Target Number of Participant 25 
Arm Type Experimental 
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 2 Arm Label Sham TEA group 
Target Number of Participant 25 
Arm Type Sham comparator 
Arm Description Sham TEA group is treated in the same manner as the TEA group using the Sham device(needle removed PDO thread). 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Diseases of the musculo-skeletal system and connective tissue
 
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 19 Year ~ 65 Year
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  
Exclusion Criteria 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  
Healthy Volunteers  
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome /Safety/Efficacy 
Primary Outcome(s) 1 
- Outcome VAS(Visual Analogue Scale) 
- Timepoint 0 week(baseline), 2 week, 5 week, 7 week  
Primary Outcome(s) 2 
- Outcome Safety assessment(Adverse effect)  
- Timepoint every visit  
Secondary Outcome(s) 1 
- Outcome NDI(Neck Disability Index) 
- Timepoint 0 week(baseline), 2 week, 5 week, 7 week  
Secondary Outcome(s) 2 
- Outcome Clinical relevance(MCID ratio)  
- Timepoint 0 week(baseline), 2 week, 5 week, 7 week  
Secondary Outcome(s) 3 
- Outcome PPT (Pressure Pain Threshold)  
- Timepoint 0 week(baseline), 2 week, 5 week, 7 week  
Secondary Outcome(s) 4 
- Outcome HADS (Hospital anxiety and depression scale)  
- Timepoint 0 week(baseline), 2 week, 5 week, 7 week  
Secondary Outcome(s) 5 
- Outcome EQ-5D(EuroQol)  
- Timepoint 0 week(baseline), 2 week, 5 week, 7 week  
Secondary Outcome(s) 6 
- Outcome PGIC(Patient Global Impression of change) 
- Timepoint 5 week, 7 week  
Secondary Outcome(s) 7 
- Outcome Blinding test 
- Timepoint 0 week(baseline), 3 week 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration