Chronic Low-back PainNCT07395102
Effectiveness of Thread-Embedding Acupuncture at EX-B2 on the Oswestry Disability Index and Finger-to-Floor Distance in Chronic Low Back Pain
A study testing Thread Embedding Acupuncture in people with Chronic Low-back Pain, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Thread Embedding Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Mar 2026to 29 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Thread Embedding Acupuncture, Sham Thread Embedding Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread Embedding AcupunctureDevice
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.
Sham Thread Embedding AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Thread Embedding Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes (1)
Change in Finger-to-Floor Distance (FFD)
The Finger-to-Floor Distance (FFD) assesses lumbar flexibility by measuring the distance (in centimeters) between the fingertips and the floor during maximal forward trunk flexion. Values range from 0 cm to higher positive values, with lower scores indicating better lumbar flexibility. A decrease in FFD represents improvement in lumbar flexibility.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start13 Mar 2026
- Primary completion13 May 2026
- Study completion29 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Desi Recsanti, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395102
- Sponsor's protocol ID
- 25-12-1949
- Status last verified
- Jan 2026
- First submitted
- 25 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. Only aggregate study results will be reported in publications.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Thread-Embedding Acupuncture at EX-B2 on the Oswestry Disability Index and Finger-to-Floor Distance in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07395102
- Acronym / sponsor ID
- 25-12-1949
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 13 Mar 2026 (actual)
- Primary completion
- 13 May 2026 (actual)
- Study completion
- 29 May 2026 (actual)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Thread Embedding Acupuncture (TEA) | Experimental | Device: Thread Embedding AcupunctureParticipants 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. |
| Control Group - Sham Thread Embedding Acupuncture | Sham comparator | Device: Sham Thread Embedding AcupunctureParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thread Embedding AcupunctureParticipants 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 | Intervention Group - Thread Embedding Acupuncture (TEA) |
| Sham Thread Embedding AcupunctureParticipants 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 | Control Group - Sham Thread Embedding Acupuncture |
Primary outcome
Change in Oswestry Disability Index (ODI)
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
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.
1 secondary outcome
Change in Finger-to-Floor Distance (FFD)
Time frame: Baseline, Week 4, and Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. Only aggregate study results will be reported in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KEPK FKUI-RSCM principal investigator
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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thread Embedding Acupuncture in people with Chronic Low-back Pain, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oswestry Disability Index (ODI) (time frame: Baseline, Week 2, Week 4, Week 6, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.