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Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial

Lee et al. · Trials · 2018

🔬Controlled Pilot RCT👥n = 40 participantsModerate Evidence

Evidence Level

MODERATE
72/ 100
Quality
4/5
Sample
3/5
Replication
3/5
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OBJECTIVE

To investigate the efficacy and safety of thread embedding acupuncture (TEA) for chronic low back pain

👥

WHO

40 adults with chronic low back pain for at least 6 months

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DURATION

8 weeks of treatment plus 2 weeks of follow-up

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POINTS

TEA: 17 sites (39 threads total); Acupuncture: 19 traditional points with electrical stimulation

🔬 Study Design

40participants
randomization

TEA Group

n=20

Acupuncture with absorbable threads every 2 weeks (4 sessions)

Acupuncture Group

n=20

Traditional acupuncture twice a week (16 sessions)

⏱️ Duration: 8 weeks of treatment

📊 Results in numbers

Significant

Pain improvement (VAS) — both groups

0%

Study completion rate

p < 0.05

Disability improvement (ODI) — TEA vs Acupuncture

0

Serious adverse events

Percentage highlights

90%
Study completion rate

📊 Outcome Comparison

Visual Analog Pain Scale (VAS)

TEA (baseline)
6.04
TEA (10 weeks)
2.34
Acupuncture (baseline)
5.91
Acupuncture (10 weeks)
2.79
💬 What does this mean for you?

This study showed that both acupuncture with absorbable threads and traditional acupuncture are effective in reducing chronic low back pain. The thread technique may offer advantages by requiring fewer sessions (4 vs 16), while maintaining similar results in pain reduction and improvement of functional capacity.

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Article summary

Plain-language narrative summary

This randomized controlled pilot study investigated an innovative technique called thread embedding acupuncture (TEA) for the treatment of chronic low back pain. Chronic low back pain affects up to 85% of the population at some point in life and represents a significant therapeutic challenge, leading many patients to seek complementary therapies such as acupuncture. TEA is a variation of traditional acupuncture that uses absorbable threads (polydioxanone) inserted into specific points, where they remain for weeks, providing continuous stimulation. The study was conducted at the Korean Hospital of Daegu, South Korea, with 40 adult participants who had chronic low back pain for at least 6 months, diagnosed by imaging studies.

Participants were randomized into two groups: the TEA group received 4 treatment sessions (one every 2 weeks), with insertion of 39 absorbable threads at 17 specific locations on the back and abdomen; the control group received traditional acupuncture with electrical stimulation, totaling 16 sessions (twice per week) at 19 acupuncture points. The methodology followed rigorous standards with blinded assessors and adequate randomization. Outcomes were measured using the Visual Analog Scale (VAS) for pain, the Short-Form McGill Pain Questionnaire (SF-MPQ), and the Oswestry Disability Index (ODI). Assessments occurred at baseline and at 2, 4, 6, 8, and 10 weeks.

Both groups showed statistically significant improvements in all parameters over time. On the VAS pain scale, the TEA group decreased from 6.04 to 2.34 points, while the acupuncture group decreased from 5.91 to 2.79 points. An important difference was observed on the Disability Index (ODI), where there was a significant interaction between groups and time, suggesting that TEA may provide better functional improvement compared with traditional acupuncture at week 8. As for safety, no serious adverse events were recorded.

Only two participants in the acupuncture group reported mild itching in the lumbar region. Laboratory tests performed before and after treatment remained within normal limits, including specific tests to detect possible infection in the TEA group. The adherence rate was excellent (100% of participants who completed), and only 4 participants dropped out for reasons unrelated to the treatment. The clinical implications suggest that TEA may be an interesting alternative to traditional acupuncture, especially considering that it requires significantly fewer sessions (4 vs 16) while maintaining similar efficacy.

This could reduce costs and facilitate access to treatment. The proposed mechanism involves continuous stimulation of the core muscles and ligaments around the spine through the absorbable threads, which dissolve slowly, stimulating collagen fiber formation. As limitations, the study acknowledges the small sample size typical of pilot studies, the inability to blind patients and providers, and the need for further research on mechanisms of action and long-term safety.

Strengths

  • 1Rigorous methodological design with randomization and blinded assessors
  • 2Comprehensive safety assessment including laboratory tests
  • 3High adherence rate and low dropout
  • 4Use of validated instruments to measure outcomes
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Limitations

  • 1Small sample size (pilot study)
  • 2Inability to blind patients and providers
  • 3Mechanism of action of TEA not yet fully elucidated
  • 4Follow-up of only 2 weeks after treatment
Dr. Marcus Yu Bin Pai

Expert Commentary

Dr. Marcus Yu Bin Pai

MD, PhD · Pain Medicine · Physical Medicine and Rehabilitation · Medical Acupuncture

Clinical Relevance

Chronic low back pain remains one of the greatest challenges in rehabilitation, and any intervention that reduces session burden without compromising outcomes deserves serious clinical attention. Thread embedding acupuncture (TEA) delivers continuous stimulation at specific points by means of polydioxanone threads, compressing the number of in-person visits from 16 to 4 over 8 weeks — an operationally relevant difference for high-demand services and for patients with difficulty in frequent travel. The safety profile documented here, with serial laboratory tests and absence of serious adverse events, offers the minimum support required to consider the technique in a supervised clinical setting. Patients with moderate to high intensity nonspecific chronic low back pain, especially those with compromised adherence to multiple-session schedules, constitute the most promising subgroup for this approach within a multimodal rehabilitation program.

Notable Findings

The finding that most catches attention is not the pain reduction — both groups improved comparably on the VAS, with the TEA group going from 6.04 to 2.34 points and the acupuncture group from 5.91 to 2.79 — but rather the significant interaction between group and time on the Oswestry Disability Index (ODI) at week 8, suggesting a functional advantage for TEA despite the lower number of sessions. This dissociation between pain and functional outcomes is conceptually consistent with the hypothesis that continuous mechanical stimulation from absorbable threads acts on the spinal stabilizing musculature differently from conventional pulsatile acupuncture. The proposed mechanism — collagen synthesis induced by progressive thread dissolution — brings TEA closer to reasoning used in tissue stimulation procedures, which opens an interesting dialogue with interventional physiatry.

From My Experience

In my practice, patients with nonspecific chronic low back pain frequently arrive at the service after having abandoned long courses of physical therapy or conventional acupuncture for logistical reasons, not for lack of clinical response. I have observed that the adherence barrier is as limiting as the efficacy of the technique itself. I usually see a perceptible clinical response from traditional acupuncture between the third and fifth sessions, with a functional plateau around 10 to 12 sessions, followed by monthly maintenance. TEA, through persistent stimulation, could fit as an induction phase within a protocol that combines lumbar stabilization exercise, postural guidance, and possible adjuvant analgesia in flare phases. I would not indicate the technique in immunosuppressed patients, with a history of reactions to absorbable materials, or with active regional infection. The profile that responds best, in my experience with analogous techniques, is the patient with predominantly myofascial pain, without overt radicular irradiation, and with good understanding of the therapeutic process.

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture.

Full original article

Read the full scientific study

Trials · 2018

DOI: 10.1186/s13063-018-3049-x

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Scientific Review

Marcus Yu Bin Pai, MD, PhD

Marcus Yu Bin Pai, MD, PhD

CRM-SP: 158074 | RQE: 65523 · 65524 · 655241

PhD in Health Sciences, University of São Paulo. Board-certified in Pain Medicine, Physical Medicine and Rehabilitation, and Medical Acupuncture. Scientific review and curation of every entry in this library.

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Medical disclaimer: This content is for educational purposes only and does not replace consultation, diagnosis, or treatment by a qualified professional. Some information may be assisted by artificial intelligence and is subject to inaccuracies. Always consult a physician.

Content reviewed by the medical team at CEIMEC — Integrated Centre for Chinese Medicine Studies, a reference in Medical Acupuncture for over 30 years.