NCT07395102

Effectiveness of Thread-Embedding Acupuncture at EX-B2 on the Oswestry Disability Index and Finger-to-Floor Distance in Chronic Low Back Pain

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Chronic low back pain (CLBP) is a leading cause of disability worldwide and significantly impairs functional capacity and quality of life. Non-pharmacological therapies are recommended as first-line management, and acupuncture has demonstrated potential benefits in reducing pain and disability. Thread embedding acupuncture (TEA) is a modified acupuncture technique that provides prolonged stimulation through the implantation of absorbable polydioxanone (PDO) threads at acupuncture points. This randomized controlled trial aims to evaluate the effectiveness of TEA at the EX-B2 points compared with sham TEA in improving disability and lumbar flexibility in patients with chronic non-specific low back pain. Disability will be assessed using the Oswestry Disability Index (ODI), and lumbar flexibility will be measured using the Finger-to-Floor Distance (FFD) test over an 8-week follow-up period.

Detailed description

Chronic low back pain (CLBP) is a major contributor to global disability and reduced functional performance. Conventional management such as analgesics and physiotherapy often provides limited long-term functional improvement. Acupuncture has been recommended as a non-pharmacological treatment option for CLBP, and evidence suggests it can reduce pain and disability. Thread embedding acupuncture (TEA) is a modified acupuncture technique in which absorbable medical threads are implanted into specific acupuncture points, providing continuous stimulation over several weeks. This prolonged stimulation is believed to enhance neuromodulation, improve local microcirculation, and promote tissue repair, potentially leading to sustained clinical benefits. The EX-B2 points are located 0.5 cun lateral to the spinous processes from T1 to L5 and are anatomically close to the paraspinal muscles and posterior nerve roots. Stimulation of these points may modulate pain pathways and improve lumbar function. This study is designed as a randomized controlled trial comparing TEA at EX-B2 points with sham TEA in patients with chronic low back pain. The primary outcome is change in disability measured by the Oswestry Disability Index (ODI) at weeks 2, 4, 6, and 8 after intervention. The secondary outcome is change in lumbar flexibility measured by Finger-to-Floor Distance (FFD) at weeks 4 and 8. Adverse events related to the procedure will also be recorded to evaluate safety.

Conditions

• Chronic Low-back Pain

Interventions

Type	Name	Description
DEVICE	Thread Embedding Acupuncture	Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.
DEVICE	Sham Thread Embedding Acupuncture	Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. The assigned procedures will be administered once, and outcomes will be evaluated over an 8-week follow-up period.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: Indonesia