Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine

Not Applicable

Completed

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0002439
• Lead Sponsor: Kyung Hee University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 February 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Male or female adults aged 19-70
2. Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
3. 40 or higher low back pain on 100mm pain visual analogue scale
4. Volunteers who agree to participate and sign the Informed Consent Form, following a detailed explanation of clinical trials

Exclusion Criteria

1. Congenital abnormalities or surgical history on lumbar regions
2. Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
3. Tumor, fracture or infection in lumbar regions
4. Injection treatment on lumbar regions within 1 week
5. Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
6. Inappropriate condition for thread-embedding acupuncture due to skin disease or hemostatic disorder (PT INR > 2.0 or taking anticoagulant)
7. Other diseases that could affect or interfere with therapeutic outcomes, including severe gastrointestinal disease, cardiovascular disease, hypertension, diabetes, renal disease, liver disease or thyroid disorder
8. Contraindication of acetaminophen including intercurrent disease, hypersensitivity reaction or other medication
9. Pregnant women or other inappropriate condition for thread-embedding acupuncture
10. Heavy drinking (more than 3 cups per day) that could cause hepatotoxicity with acetaminophen

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
100mm Pain Visual Analogue Scale (VAS) for low back pain

Secondary Outcome Measures

Name	Time	Method
100mm Pain Visual Analogue Scale (VAS) for radiating pain;Oswestry Disability Index (ODI);EuroQol-5 dimensions-5 level (EQ-5D-5L);Roland-Morris Disability Questionnaire (RMDQ);Global Perceived Effect (GPE)