Skip to main content
OpenTrials
Completed

NCT Number: NCT03236753

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lumbar Disc Herniation Back Pain Bone Diseases Hernia Intervertebral Disc Displacement Low Back Pain Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Radiculopathy Signs and Symptoms Spinal Diseases

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongguk University Bundang Oriental Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

Seventy patient between the ages of 19 and 70 with L-HIVD will be recruited by eligibility criteria and randomly allocated to the thread-embedding acupuncture (TEA) group and sham thread-embedding acupuncture (STEA) group. Both groups will receive treatment on predefined 23 acupoints once a week for 8 weeks, and needle with thread removed will be used in STEA group instead of normal TEA. 100 mm visual analogue scale (VAS) for low back pain will be assessed as a primary outcome. Also, 100mm VAS for radiating pain, Oswestry disability index (ODI), Rolland Morris disability questionnaire (RMDQ), EQ-5D-5L and global perceived effect (GPE) will be measured as secondary outcomes. All the outcomes will be assessed at baseline, 4 weeks after screening, treatment end (8 weeks, primary end point) and follow-up sessions (12 and 16 weeks).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Congenital abnormalities or surgical history on lumbar regions
  • Red flag signs that may be suspected of cauda equina syndrome, such as bladder and bowel dysfunction or saddle anesthesia
  • Tumor, fracture or infection in lumbar regions
  • Injection treatment on lumbar regions within 1 week
  • Psychiatric disorder currently undergoing treatment such as depression or schizophrenia
  • Inappropriate condition for thread-embedding acupuncture due to skin disease or hemostatic disorder (PT INR > 2.0 or taking anticoagulant)
  • 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
  • Contraindication of acetaminophen including intercurrent disease, hypersensitivity reaction or other medication
  • Pregnant women or other inappropriate condition for thread-embedding acupuncture
  • Heavy drinking (more than 3 cups per day) that could cause hepatotoxicity with acetaminophen

Treatment and study plan

Thread-embedding Acupuncture (TEA)

Procedure

The acupoints and size of TEA are as follows:

  • Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm
  • Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm
  • Both BL25: transverse insertion toward iliac crest, 4cm
  • Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm
  • Both BL26: oblique insertion toward iliolumbar ligament, 6cm
  • Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm
  • Both BL28: oblique insertion toward sacroiliac ligament, 6cm
  • Both GB30: perpendicular insertion, 6cm
  • Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm

Sham Thread-embedding Acupuncture (STEA)

Procedure

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.

Primary outcomes

  1. Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8

    Time frame: Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U)

    Measurement instrument for subjective pain

Secondary outcomes

  1. 100mm Pain Visual Analogue Scale (VAS) for radiating pain

    Time frame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)

    Measurement instrument for subjective pain

  2. Oswestry Disability Index (ODI)

    Time frame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)

    Validated questionnaire for disability of low back pain.

  3. EuroQol-5 dimensions-5 level (EQ-5D-5L)

    Time frame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)

    Standardized instrument for generic health status

  4. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)

    Health status measure for low back pain

  5. Global Perceived Effect (GPE)

    Time frame: Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)

    Assessment of change in the patient's chief complaint

Sponsors and collaborators

Lead sponsor

Kyunghee University Medical Center

Other

Collaborators

  • Daegu Korean Medicine Hospital of Daegu Haany University
  • DongGuk University
  • Kyung Hee University Hospital at Gangdong

Registry information

Official study title

Clinical Research on the Efficacy and Safety of Thread-embedding Acupuncture for Treatment of Herniated Intervertebral Disc of Lumbar Spine; A Multicenter, Randomized, Patient-assessor Blinded, Controlled, Parallel Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 2, 2017
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.