Clinical trial NCT03236753: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Disc Herniation
Keywords: Thread-Embedding Acupuncture
Herniated Intervertebral Disc of Lumbar Spine
Low Back Pain
Radiculopathy
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Kyung Hee University Hospital at Gangdong
name: DongGuk University
name: Daegu Korean Medicine Hospital of Daegu Haany University
First posted: 2017-08-02
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline 100mm Pain Visual Analogue Scale (VAS) for low back pain at Week 8
timeFrame: Week 1 (Baseline), Week 4, Week 8 (Primary end point, Treatment end), Week 12, Week 16 (F/U)
Secondary outcomes:
measure: 100mm Pain Visual Analogue Scale (VAS) for radiating pain
timeFrame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
measure: Oswestry Disability Index (ODI)
timeFrame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
measure: EuroQol-5 dimensions-5 level (EQ-5D-5L)
timeFrame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
measure: Roland-Morris Disability Questionnaire (RMDQ)
timeFrame: Week 1 (Baseline), Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
measure: Global Perceived Effect (GPE)
timeFrame: Week 4, Week 8 (Treatment end), Week 12, Week 16 (F/U)
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Dongguk University Bundang Oriental Hospital
state: Gyeonggi
city: Daegu
country: Korea, Republic of
facility: Daegu Korean Medicine Hospital of Daegu Haany University
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Kyunghee University Medical Center
name: Byung-Kwan Seo, PhD., KMD
role: PRINCIPAL_INVESTIGATOR
References:
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.