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

NCT07395102 | Completed

• 1 other identifier: 25-12-1949
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index (ODI)

  The Oswestry Disability Index (ODI) is a validated questionnaire assessing disability related to low back pain. Scores range from 0 to 100, with higher scores indicating greater disability and worse functional status. A decrease in ODI score represents improvement in functional disability.

  Baseline, Week 2, Week 4, Week 6, and Week 8

Secondary Outcomes (1)

• Change in Finger-to-Floor Distance (FFD)

  Baseline, Week 4, and Week 8

Other Outcomes (1)

• Incidence and Type of Adverse Events Related to Thread Embedding Acupuncture

  Through study completion, an average of 8 weeks.

Study Arms (2)

Intervention Group - Thread Embedding Acupuncture (TEA)

EXPERIMENTAL

Participants in this group will receive thread embedding acupuncture using absorbable polydioxanone (PDO) threads implanted bilaterally at EX-B2 acupuncture points corresponding to the lumbar vertebral segments. The procedure will be performed only once weekly at week 0. This intervention is intended to provide continuous stimulation of acupuncture points to reduce disability and improve lumbar flexibility in patients with chronic low back pain.

Device: Thread Embedding Acupuncture

Control Group - Sham Thread Embedding Acupuncture

SHAM COMPARATOR

Participants in the control group will receive a sham thread embedding acupuncture procedure that mimics the intervention in terms of patient positioning, skin preparation, and needle insertion technique, but without implantation of polydioxanone (PDO) threads. No absorbable thread will be left in the tissue. The procedure will be performed only once weekly at week 0. This group serves as a placebo control to evaluate the specific effects of thread embedding acupuncture beyond nonspecific procedural effects.

Device: Sham Thread Embedding Acupuncture

Interventions

Thread Embedding Acupuncture DEVICE

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.

Intervention Group - Thread Embedding Acupuncture (TEA)

Sham Thread Embedding Acupuncture DEVICE

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.

Control Group - Sham Thread Embedding Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants aged ≥ 18 years
• Participants experiencing low back pain for at least 3 months (\>12 weeks)
• Highest low back pain intensity within the past 2 weeks with a score of ≥ 3 on a 0-10 Numeric Pain Rating Scale (NPRS)
• Receiving pharmacological therapy with a stable analgesic regimen for at least 2 weeks prior to enrollment
• Presence of physical functional disability as indicated by an Oswestry Disability Index (ODI) score \> 20%
• Willing and able to participate in the study until completion and to provide written informed consent

You may not qualify if:

• History of hypersensitivity reactions to acupuncture or thread embedding acupuncture, or known allergy to stainless steel or polydioxanone (PDO) threads
• History of keloid formation
• Presence of scars (cicatrices) or skin disorders at the thread embedding acupuncture insertion sites in the lower back area
• Specific spinal pathology including fracture, tumor, infection, or severe lumbar spinal stenosis requiring surgical intervention
• Structural spinal abnormalities (scoliosis or kyphosis) detected on physical examination
• History of spinal surgery or indication for spinal surgery due to severe neurological deficits
• Presence of cardiac disease, hematological disorders, or uncontrolled diabetes mellitus
• Regular use of systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, or topical analgesic medications
• Receipt of other treatments for low back pain, including dry needling, neuromuscular taping, spinal injections, or acupuncture within the past 2 weeks, or thread embedding acupuncture within the past 6 months
• Severe cognitive impairment, severe psychiatric or psychological disorders, or history of alcohol or substance abuse
• Pregnant or breastfeeding women, or women planning pregnancy within the next 6 months
• Body mass index (BMI) \< 18 kg/m²

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Study Officials

• KEPK FKUI-RSCM

  Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital (HREC FMUI-CMH) (Komite Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Indonesia - RSUP Nasional Dr. Cipto Mangunkusumo)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be blinded to group allocation. The sham procedure will be designed to be visually and procedurally similar to the active thread embedding acupuncture intervention. Outcome assessors will be blinded to treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Faculty of Medicine, Universitas Indonesia

Model Details: Participants will be randomly assigned to one of two groups: Thread Embedding Acupuncture (TEA) group Sham Thread Embedding Acupuncture (Control) group Both groups will receive procedures with identical appearance and schedule. The intervention group will receive implantation of absorbable polydioxanone (PDO) threads at EX-B2 acupuncture points, while the control group will receive a sham procedure without thread implantation. Participants will be followed for 8 weeks after the intervention.

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: February 9, 2026
• Study Start: March 13, 2026
• Primary Completion: May 13, 2026
• Study Completion: May 29, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)