NCT03236753

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 2, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

August 11, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

July 25, 2017

Last Update Submit

February 5, 2020

Conditions

Lumbar Disc Herniation

Keywords

Thread-Embedding AcupunctureHerniated Intervertebral Disc of Lumbar SpineLow Back PainRadiculopathy

Outcome Measures

Primary Outcomes (1)

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

    Measurement instrument for subjective pain

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

Secondary Outcomes (5)

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

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

  • Oswestry Disability Index (ODI)

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

  • EuroQol-5 dimensions-5 level (EQ-5D-5L)

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

  • Roland-Morris Disability Questionnaire (RMDQ)

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

  • Global Perceived Effect (GPE)

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

Study Arms (2)

Thread-Embedding Acupuncture (TEA)

EXPERIMENTAL

The TEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm TEA on predefined 23 acupoints selected by expert group according to STRICTA. All other treatment affecting the outcomes will be prohibited during the trial period. All therapeutic procedure will be performed by acupuncture specialists who have received training for the consensus of multicenter.

Procedure: Thread-embedding Acupuncture (TEA)

Sham Thread-Embedding Acupuncture (STEA)

SHAM COMPARATOR

The STEA group will be treated once a week for 8 weeks, using 29G x 40mm or 29G x 60mm sham TEA on predefined 23 acupoints selected by expert group according to STRICTA.

Procedure: Sham Thread-embedding Acupuncture (STEA)

Interventions

Thread-embedding Acupuncture (TEA)PROCEDURE

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

Thread-Embedding Acupuncture (TEA)
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.

Sham Thread-Embedding Acupuncture (STEA)

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female adults aged 19-70
  • Radiating pain matched with severer abnormality than bulging shown by CT or MRI on lumbar spine
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Dongguk University Bundang Oriental Hospital

Seongnam-si, Gyeonggi-do, 13601, South Korea

Location

Daegu Korean Medicine Hospital of Daegu Haany University

Daegu, 42158, South Korea

Location

Kyunghee University Medical Center

Seoul, 02447, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Related Publications (1)

  • Goo B, Ryoo DW, Kim EJ, Nam D, Lee HJ, Kim JS, Park YC, Baek YH, Seo BK. Clinical research on the efficacy and safety of thread-embedding acupuncture for treatment of herniated intervertebral disc of the lumbar spine: a protocol for a multicenter, randomized, patient-assessor blinded, controlled, parallel, clinical trial. Trials. 2018 Sep 10;19(1):484. doi: 10.1186/s13063-018-2864-4.

    PMID: 30201029DERIVED

MeSH Terms

Conditions

Intervertebral Disc DisplacementLow Back PainRadiculopathy

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and SymptomsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Byung-Kwan Seo, PhD., KMD

    Kyunghee University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD., KMD

Study Record Dates

First Submitted

July 25, 2017

First Posted

August 2, 2017

Study Start

August 11, 2017

Primary Completion

June 4, 2019

Study Completion

July 30, 2019

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(4)