The Combination of Thread-embedding and Auricular Acupuncture in the Treatment of Non-specific Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change in Oswestry Disability Index (ODI) percentage score
研究概览
简要总结
Low back pain (LBP) is a significant global health issue, with cases expected to rise by 36.4% by 2050. Chronic LBP (cLBP), lasting over three months, is mostly non-specific cLBP (cNLBP), posing a challenge for effective management. Common treatments include medication, exercise, and acupuncture.
This study explores the combined use of thread-embedding and auricular acupuncture for treating cNLBP, as combining these methods is thought to enhance effectiveness. Participants with cNLBP will be randomized into four groups to receive either the combination of both treatments, each treatment individually with a sham, or both shams. The study will last eight weeks, with four weeks of intervention and four weeks of follow-up. Treatment outcomes, including pain, disability, medication use, and quality of life, will be evaluated, along with monitoring for adverse effects.
详细描述
Low back pain (LBP) is a major public health issue worldwide. In 2020, there were over half a billion cases of LBP globally, and by 2050, the total number of LBP cases is expected to increase by 36.4% worldwide. LBP accounts for 7.7% of total Years Lived with Disability, making it the largest contributor to the global disability burden.
When lasting three months or more, LBP is classified as chronic (cLBP). Most cLBP is non-specific cLBP (cNLBP). Managing cNLBP remains challenging. Recommended therapies include short-term medication, manipulation, supervised exercise, cognitive behavioral therapy, and multidisciplinary treatment. According to the Clinical Practice Guideline from the American College of Physicians, clinicians and patients should initially consider non-pharmacologic treatments, including acupuncture as one of the options.
There is evidence regarding the effectiveness of thread-embedding acupuncture (TEA) and auricular acupuncture (AA) in the treatment of cNLBP. TEA uses the principle of selecting points on the body, while AA involves selecting points on the ear. The difference in the point selection principles of these two methods has led clinicians to often combine them in hopes of enhancing treatment efficacy. However, evidence on the effectiveness of combining these two methods in treating cNLBP remains lacking. This study aims to clarify whether the combination of these methods is more effective than using them individually.
Eligible participants with cNLBP, defined as LBP lasting more than three months without any reasonable explanation and determined by a physician to be nonspecific, will be enrolled and subsequently randomized into four groups: receiving the combination of TEA and AA (TEA + AA group), receiving TEA and sham AA (TEA + sham AA group), receiving AA and sham TEA (AA + sham TEA group), and receiving sham TEA and sham AA (Sham both group), with a 1:1:1:1 allocation ratio.
The study will last for eight weeks, with four weeks of intervention and four weeks of follow-up. AA and sham AA will be administered weekly during the four-week intervention (four sessions). TEA and sham TEA will be administered every two weeks during the four-week intervention (two sessions). Data on treatment efficacy will include disability index, pain score, amount of analgesic medication needed, quality of life score, and global improvement. Additionally, adverse effects will be monitored and recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with low back pain at the outpatient clinic.
- •Diagnosed with non-specific low back pain persisting for more than 3 months, without radiation to the legs.
- •Pain-NRS score ≥ 4 on a 10-point scale.
- •Independent ambulation capability (with or without walking aids).
- •Consent to participate in the study.
排除标准
- •History of prior lumbar spine surgery.
- •Known or suspected severe spinal conditions (e.g., cancer, vertebral fracture, spinal infection, or cauda equina syndrome).
- •Signs of concurrent involvement of lumbar nerve roots, plexus, sciatic nerve, other leg nerves, or diagnosed polyneuropathy confirmed by electrodiagnosis.
- •Presence of systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis.
- •Unstable or untreated severe health conditions (such as end-stage renal disease, advanced liver failure, NYHA class IV heart failure).
- •Alcohol abuse or substance dependence.
- •Use of anti-inflammatory medication within 2 weeks prior to enrollment.
- •Acupuncture treatment within the past 4 weeks.
- •Previous treatment with thread-embedding or auricular acupuncture for any condition.
- •Damaged skin in the acupuncture area or history of hypersensitivity reactions to acupuncture.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
AA + sham TEA
Auricular acupuncture (AA) every week in 4 weeks (4 sessions). Combined with sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions).
干预措施: Auricular acupuncture (Other)
TEA + AA
Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with auricular acupuncture (AA) every week in 4 weeks (4 sessions).
干预措施: Thread-embedding acupuncture (Other)
TEA + AA
Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with auricular acupuncture (AA) every week in 4 weeks (4 sessions).
干预措施: Auricular acupuncture (Other)
AA + sham TEA
Auricular acupuncture (AA) every week in 4 weeks (4 sessions). Combined with sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions).
干预措施: Sham thread-embedding acupuncture (Other)
TEA + sham AA
Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions).
干预措施: Thread-embedding acupuncture (Other)
TEA + sham AA
Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions).
干预措施: Sham auricular acupuncture (Other)
Sham both
Sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions).
干预措施: Sham thread-embedding acupuncture (Other)
Sham both
Sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions).
干预措施: Sham auricular acupuncture (Other)
结局指标
主要结局
Change in Oswestry Disability Index (ODI) percentage score
时间窗: Week 0, Week 2, Week 4, Week 6, and Week 8
The Oswestry Disability Index (ODI) percentage score evaluates the impact of low back pain on various activities (sleeping, self-care, sex life, social life, and traveling) using six rating options (0 to 5). Participants select the most appropriate response, and the total score is calculated as a percentage of the maximum possible score (50 if all sections are completed). A score of zero indicates no disability, while a score of 100% implies significant disability.
次要结局
- Change in pain score on the Numeric Rating Scale (NRS)(Week 0, Week 2, Week 4, Week 6, and Week 8)
- Change in the number of paracetamol tablets used(Week 2, Week 4, Week 6, and Week 8)
- Change in the Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS-GH-10) score(Week 0, Week 2, Week 4, Week 6, and Week 8)
- Global improvement rate(Week 2, Week 4, Week 6, and Week 8)
- Proportion of intervention-related adverse events(Up to eight weeks)
研究者
Tin Trong Nguyen
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City