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Lumbar Disc HerniationNCT03236753

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

A study testing Thread-embedding Acupuncture (TEA) in people with Lumbar Disc Herniation, run by Kyunghee University Medical Center at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Lumbar Disc Herniation
What is being tested?
Thread-embedding Acupuncture (TEA)
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
4 sitesSouth Korea
Study dates
11 Aug 2017to 30 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Daegu Korean Medicine Hospital of Daegu Haany University

    Daegu, 42158

  • Dongguk University Bundang Oriental Hospital

    Seongnam-si, Gyeonggi-do, 13601

  • Kyunghee University Medical Center

    Seoul, 02447

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

Other trials in South Korea

About this study

Official 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

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.

Read the detailed description

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).

Being tested
Thread-embedding Acupuncture (TEA), Sham Thread-embedding Acupuncture (STEA)
Keywords
Thread-Embedding Acupuncture, Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy
Medical subject headings
Intervertebral Disc Displacement, Low Back Pain, Radiculopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thread-embedding Acupuncture (TEA)Procedure or surgery

    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

  • Sham Thread-embedding Acupuncture (STEA)Procedure or surgery

    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.

Study groups in NCT03236753
Study groupRoleWhat they receive
Thread-Embedding Acupuncture (TEA)ExperimentalThe 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.
Receives: Procedure: Thread-embedding Acupuncture (TEA)
Sham Thread-Embedding Acupuncture (STEA)Sham comparatorThe 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.
Receives: Procedure: Sham Thread-embedding Acupuncture (STEA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measurement instrument for subjective pain

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

Secondary outcomes (5)

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

    Measurement instrument for subjective pain

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

  2. Oswestry Disability Index (ODI)

    Validated questionnaire for disability of low back pain.

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

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

    Standardized instrument for generic health status

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

  4. Roland-Morris Disability Questionnaire (RMDQ)

    Health status measure for low back pain

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

  5. Global Perceived Effect (GPE)

    Assessment of change in the patient's chief complaint

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2017
  2. Study start11 Aug 2017
  3. Primary completion4 Jun 2019
  4. Study completion30 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03236753
Sponsor's protocol ID
KHNMCOH 2016-09-006
Status last verified
Feb 2020
First submitted
25 Jul 2017
Last updated
6 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30201029

Questions about this trial

What is this clinical trial studying?

A study testing Thread-embedding Acupuncture (TEA) in people with Lumbar Disc Herniation, run by Kyunghee University Medical Center at 4 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03236753, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.

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