Clinical trial NCT06682273: Thread-embedding Combined With Auricular Acupuncture for Non-specific Chronic Low Back Pain
Official title: The Combination of Thread-embedding and Auricular Acupuncture in the Treatment of Non-specific Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non-Specific Low Back Pain
Keywords: acupuncture
thread embedding acupuncture
auricular acupuncture
low back pain
traditional medicine
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Oswestry Disability Index (ODI) percentage score
timeFrame: Week 0, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes:
measure: Change in pain score on the Numeric Rating Scale (NRS)
timeFrame: Week 0, Week 2, Week 4, Week 6, and Week 8
measure: Change in the number of paracetamol tablets used
timeFrame: Week 2, Week 4, Week 6, and Week 8
measure: Change in the Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS-GH-10) score
timeFrame: Week 0, Week 2, Week 4, Week 6, and Week 8
measure: Global improvement rate
timeFrame: Week 2, Week 4, Week 6, and Week 8
measure: Proportion of intervention-related adverse events
timeFrame: Up to eight weeks
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Nhan Dan Gia Dinh Hospital
Study officials:
References:
citation: Hunter RF, McDonough SM, Bradbury I, Liddle SD, Walsh DM, Dhamija S, Glasgow P, Gormley G, McCann SM, Park J, Hurley DA, Delitto A, Baxter GD. Exercise and Auricular Acupuncture for Chronic Low-back Pain: A Feasibility Randomized-controlled Trial. Clin J Pain. 2012 Mar-Apr;28(3):259-67. doi: 10.1097/AJP.0b013e3182274018.
citation: Lee HJ, Choi BI, Jun S, Park MS, Oh SJ, Lee JH, Gong HM, Kim JS, Lee YJ, Jung SY, Han CH. Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial. Trials. 2018 Dec 12;19(1):680. doi: 10.1186/s13063-018-3049-x.
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citation: Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.