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

Not Applicable

Completed

• Conditions: Lumbar Disc Herniation
• Interventions: Procedure: Sham Thread-embedding Acupuncture (STEA); Procedure: Thread-embedding Acupuncture (TEA)

• Registration Number: NCT03236753
• Lead Sponsor: Kyunghee University Medical Center

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).

Study Timeline

• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-28
• Study First Posted: 2017-08-02
• Study Start: 2017-08-11
• Primary Completion: 2019-06-04
• Study Completion: 2019-07-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Thread-Embedding Acupuncture (STEA)	Sham Thread-embedding Acupuncture (STEA)	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.
Thread-Embedding Acupuncture (TEA)	Thread-embedding Acupuncture (TEA)	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8	Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U)	Measurement instrument for subjective pain

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of

Dongguk University Bundang Oriental Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of

Daegu Korean Medicine Hospital of Daegu Haany University; 🇰🇷 Daegu, Korea, Republic of