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

Lumbar Disc Herniation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03236753
• Other study ID #: KHNMCOH 2016-09-006
• Status: Completed
• Phase: N/A
• Start date: August 11, 2017
• Est. completion date: July 30, 2019

Study information

• Verified date: February 2020
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 30, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Lumbar Disc Herniation

Intervention

Procedure:
• Thread-embedding Acupuncture (TEA)
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)
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.

Locations

Country	Name	City	State
Korea, Republic of	Daegu Korean Medicine Hospital of Daegu Haany University	Daegu
Korea, Republic of	Dongguk University Bundang Oriental Hospital	Seongnam	Gyeonggi
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Kyunghee University Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Daegu Korean Medicine Hospital of Daegu Haany University, DongGuk University, Kyung Hee University Hospital at Gangdong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	100mm Pain Visual Analogue Scale (VAS) for radiating pain	Measurement instrument for subjective pain	Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Secondary	Oswestry Disability Index (ODI)	Validated questionnaire for disability of low back pain.	Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Secondary	EuroQol-5 dimensions-5 level (EQ-5D-5L)	Standardized instrument for generic health status	Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Secondary	Roland-Morris Disability Questionnaire (RMDQ)	Health status measure for low back pain	Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Secondary	Global Perceived Effect (GPE)	Assessment of change in the patient's chief complaint	Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)