Effectiveness and Safety of Polydioxanone Thread Embedding Acupuncture Compared to Physical Therapy in the Treatment of Patients with Non-specific Chronic Neck Pai
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0003720
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 128
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 chronic 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
? 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 in past 6 months
8. Skin damage that is difficult to treat on the neck
9. Hypersensitive reaction to previous acupuncture treatment, metal allergy, severe atopy, keloid, and other skin hypersensitivities
10. Hemorrhagic disease and/or factors that can affect hemostasis, such as anti-coagulant or anti-platelet drug use
11. Pregnancy, lactation, or a plan to become pregnant during childbearing years
12. Uncontrolled diabetes, or Cardiovascular disease
13. History of neurotic or major psychiatric disability or cognitive instability
14. History of alcoholism or drug abuse
15. Severe underlying disease requiring active therapy
16. Patients who are considered to be inappropriate for the study by the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method eck Pain And Disability Scale(NPDS)
- Secondary Outcome Measures
Name Time Method Clinical relevance(MCID ratio);Pressure Pain Threshold(PPT);Cervical spinal angle;Beck Depression Inventory ?(BDI-?);Beck Anxiety Inventory(BAI);Quality of life(EuroQol five dimensions questionnaire; EQ-5D);Patient Global Impression of change(PGIC);Safety assessment(Adverse effect)