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

NCT03236753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-02-06

No results posted yet for this study

Summary

This clinical trial is designed to evaluate the efficacy and safety of thread-embedding acupuncture for treatment of lumbar herniated intervertebral disc (L-HIVD) by assessing pain, function, and quality of life.

Conditions

  • Lumbar Disc Herniation

Interventions

PROCEDURE

Thread-embedding Acupuncture (TEA)

The acupoints and size of TEA are as follows: 1. Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm 2. Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm 3. Both BL25: transverse insertion toward iliac crest, 4cm 4. Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm 5. Both BL26: oblique insertion toward iliolumbar ligament, 6cm 6. Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm 7. Both BL28: oblique insertion toward sacroiliac ligament, 6cm 8. Both GB30: perpendicular insertion, 6cm 9. Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm

PROCEDURE

Sham Thread-embedding Acupuncture (STEA)

All procedure of STEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.

Sponsors & Collaborators

  • Kyung Hee University Hospital at Gangdong

    collaborator OTHER
  • DongGuk University

    collaborator OTHER
  • Daegu Korean Medicine Hospital of Daegu Haany University

    collaborator OTHER
  • Kyunghee University Medical Center

    lead OTHER

Principal Investigators

  • Byung-Kwan Seo, PhD., KMD · Kyunghee University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-11
Primary Completion
2019-06-04
Completion
2019-07-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03236753 on ClinicalTrials.gov