Efficacy and safety of Thread Embedded for Chronic Neck Pain

Efficacy and safety of Polydioxanone Thread Embedded for Chronic Non-specific Neck Pain : a randomized, subject-assessor-blinded, sham controlled pilot trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002452

Enrollment

Registered

2017-09-06

Start date

2017-05-30

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Thread Embedding Acupuncture) : 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 t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: 1. radicular pain in the upper extremity with the distribution of a particular nerve root 2. neurological abnormality as follows ? weakness, paraesthesiae(sensory deficits) ? Special test: Spurling test, Shoulder abduction relief sign test(Bakody sign) ? Hyporeflexia of DTR(Deep Tendon Reflex) ? Pathologic reflex : Hoffman sign, Babinski sign, Ankle clonus ? 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

Design outcomes

Primary

Measure	Time frame
VAS(Visual Analogue Scale);Safety assessment(Adverse effect)	—

Secondary

Measure	Time frame
NDI(Neck Disability Index);Clinical relevance(MCID ratio) ;PPT (Pressure Pain Threshold) ;HADS (Hospital anxiety and depression scale) ;EQ-5D(EuroQol) ;PGIC(Patient Global Impression of change);Blinding test	—

Countries

Korea, Republic of

Contacts

Public ContactEunseok Kim

Dunsan Korean Medicine Hospital of Daejeon University

mybestcando@naver.com+82-42-470-9140

Outcome results