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

Primary Purpose

Lumbar Disc Herniation

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Thread-embedding Acupuncture (TEA)
Sham Thread-embedding Acupuncture (STEA)
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Thread-Embedding Acupuncture, Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 VAS
  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

Sites / Locations

  • Dongguk University Bundang Oriental Hospital
  • Daegu Korean Medicine Hospital of Daegu Haany University
  • Kyunghee University Medical Center
  • Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Thread-Embedding Acupuncture (TEA)

Sham Thread-Embedding Acupuncture (STEA)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

100mm Pain Visual Analogue Scale (VAS) for radiating pain
Measurement instrument for subjective pain
Oswestry Disability Index (ODI)
Validated questionnaire for disability of low back pain.
EuroQol-5 dimensions-5 level (EQ-5D-5L)
Standardized instrument for generic health status
Roland-Morris Disability Questionnaire (RMDQ)
Health status measure for low back pain
Global Perceived Effect (GPE)
Assessment of change in the patient's chief complaint

Full Information

First Posted
July 25, 2017
Last Updated
February 5, 2020
Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong, DongGuk University, Daegu Korean Medicine Hospital of Daegu Haany University
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1. Study Identification

Unique Protocol Identification Number
NCT03236753
Brief Title
Clinical Research on the Efficacy of Thread-embedding Acupuncture on Herniated Intervertebral Disc of Lumbar Spine
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
August 11, 2017 (Actual)
Primary Completion Date
June 4, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center
Collaborators
Kyung Hee University Hospital at Gangdong, DongGuk University, Daegu Korean Medicine Hospital of Daegu Haany University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Thread-Embedding Acupuncture, Herniated Intervertebral Disc of Lumbar Spine, Low Back Pain, Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thread-Embedding Acupuncture (TEA)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Thread-Embedding Acupuncture (STEA)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Thread-embedding Acupuncture (TEA)
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Sham Thread-embedding Acupuncture (STEA)
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8
Description
Measurement instrument for subjective pain
Time Frame
Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U)
Secondary Outcome Measure Information:
Title
100mm Pain Visual Analogue Scale (VAS) for radiating pain
Description
Measurement instrument for subjective pain
Time Frame
Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Title
Oswestry Disability Index (ODI)
Description
Validated questionnaire for disability of low back pain.
Time Frame
Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Title
EuroQol-5 dimensions-5 level (EQ-5D-5L)
Description
Standardized instrument for generic health status
Time Frame
Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Title
Roland-Morris Disability Questionnaire (RMDQ)
Description
Health status measure for low back pain
Time Frame
Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Title
Global Perceived Effect (GPE)
Description
Assessment of change in the patient's chief complaint
Time Frame
Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Kwan Seo, PhD., KMD
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongguk University Bundang Oriental Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13601
Country
Korea, Republic of
Facility Name
Daegu Korean Medicine Hospital of Daegu Haany University
City
Daegu
ZIP/Postal Code
42158
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
ZIP/Postal Code
05278
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30201029
Citation
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.
Results Reference
derived

Learn more about this trial

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

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