Low Back PainNCT07337187
Effect of Thread-Embedding Acupuncture at EX-B2 Acupoint on Pain Intensity and Quality of Life in Chronic Low Back Pain
A study testing Thread-embedding acupuncture in people with Low Back Pain, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The goal of this clinical trial is to learn whether thread-embedding acupuncture (TEA) is more effective than sham thread-embedding acupuncture in treating adults with chronic low back pain. The study will also evaluate the safety of TEA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 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
- 9 Feb 2026to 30 Apr 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
- Subjects with low back pain lasting for at least 3 months (>12 weeks)
- Maximum low back pain intensity within the past 2 weeks of ≥3 on a 0-10 scale, measured using the Numeric Pain Rating Scale (NPRS) or the Face, Legs, Activity, Cry, Consolability (FLACC) scale
- Willing to participate in the study until completion and able to provide written informed consent
- Receiving pharmacological therapy with a stable analgesic regimen for at least the past 2 weeks, which may include non-opioid analgesics (paracetamol), opioid analgesics (codeine, tramadol, morphine), antidepressants (amitriptyline, duloxetine), anticonvulsants (gabapentin, pregabalin, carbamazepine), and/or muscle relaxants (eperisone, baclofen)
Who cannot join
- History of hypersensitivity to acupuncture or thread-embedding acupuncture (TEA), including allergy to stainless steel or polydioxanone threads
- History of keloid formation or skin disorders at the planned TEA insertion sites in the low back area
- Presence of specific spinal pathology, including fracture, tumor, infection, or severe lumbar spinal stenosis (Schizas grade C or D) requiring surgical intervention
- Structural spinal abnormalities (scoliosis or kyphosis) detected on physical examination
- History of spinal surgery or current indication for spinal surgery due to severe neurological deficits
- Presence of other chronic pain syndromes (fibromyalgia, myofascial pain syndrome, neuropathic pain syndrome, arthritis, chronic pelvic pain, migraine, or chronic tension-type headache) or severe comorbidities (stroke with sensory deficits, Parkinson's disease, end-stage chronic kidney disease, or terminal heart failure) that may affect pain assessment
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- Presence of cardiac disease, hematologic disorders, or uncontrolled diabetes mellitus
- Regular use of systemic steroids, nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, anticoagulants, or topical analgesics
- Body mass index (BMI) <18 kg/m²
- Receive other therapies for low back pain, including dry needling, neuromuscular taping, or acupuncture within the past 2 weeks, or thread-embedding acupuncture within the past 6 months
- Receive spinal interventional therapy (surgery or injection) within the past 3 months, or stem cell therapy for chronic low back pain within the past 12 months
- Cognitive impairment or other neurological disorders, severe psychiatric or psychological conditions, or a history of alcohol or substance abuse
- Pregnant or breastfeeding women, or women planning to become pregnant within the next 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Thread-Embedding Acupuncture at EX-B2 Acupoint on Pain Intensity and Quality of Life in Patients With Chronic Low Back Pain
The goal of this clinical trial is to learn whether thread-embedding acupuncture (TEA) is more effective than sham thread-embedding acupuncture in treating adults with chronic low back pain. The study will also evaluate the safety of TEA.
The main questions it aims to answer are:
Read more
- Does TEA reduce pain intensity more effectively than sham TEA?
- Does TEA improve quality of life compared with sham TEA?
- Does TEA reduce the frequency of bothersome pain episodes?
- Does TEA reduce the use of routine and additional (extra) pain medications?
- What side effects occur in participants receiving TEA compared with sham TEA?
Researchers will compare TEA with sham TEA (a procedure that mimics acupuncture without needle insertion or thread placement) to determine whether TEA provides greater and longer-lasting benefits for chronic low back pain.
Participants will:
- Receive a single session of TEA or sham TEA
- Continue using pain medications as prescribed by their physician
- Be evaluated at weeks 2, 4, 6, and 8 after treatment
- Complete pain assessments, quality-of-life questionnaires, and reports of pain episodes and medication use
- Attend in-person clinic visits at weeks 4 and 8, and receive telephone follow-ups at weeks 2 and 6
Read the detailed description
- In the intervention group, thread-embedding acupuncture is performed using needles containing polydioxanone (PDO) threads at the bilateral lumbar EX-B2 acupuncture points (12.5 mm lateral to the spinous process).
- In the control group, the needle is only touched to the skin at the acupuncture point area without skin penetration.
- The selection of the EX-B2 level is based on the vertebral segment from L1 to L5 that best corresponds to the subject's dominant pain location, with reference to dermatome and myotome mapping as well as the concept of lumbar segmental innervation. If available, supporting examination results (e.g., MRI or CT scan) indicating abnormalities at a specific segment are used as additional references. When more than one segment is considered possible, the midpoint level is selected.
- After completion of the study, participants in the sham thread-embedding acupuncture group are allowed to receive actual thread-embedding acupuncture therapy for chronic low back pain.
Outcome Definitions
- Bothersome pain episodes: The number of days in the past 7 days during which the subject experienced bothersome low back pain.
Bothersome low back pain is defined as pain that is sufficiently significant to interfere with daily activities, rest, concentration, or overall comfort. Mild pain or pain that does not interfere with activities is not counted.
- Frequency of routine analgesic use: The number of days in the past 7 days during which the subject consumed routine analgesic medication (taken as prescribed by a physician).
Routine analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
- Frequency of additional (rescue) analgesic use: The number of days in the past 7 days during which the subject consumed additional (as-needed) analgesic medication when pain remained bothersome.
Additional analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
- Conditions
- Low Back Pain
- Being tested
- Thread-embedding acupuncture, Sham Thread-embedding acupuncture
- Keywords
- Chronic Low Back Pain, Lumbago
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thread-embedding acupunctureDevice
Thread-embedding acupuncture is performed bilaterally at a pair of lumbar EX-B2 points using needles containing polydioxanone (PDO) threads, positioned 12.5 mm lateral to the spinous processes. The targeted EX-B2 level is selected from L1 to L5 based on the subject's main pain location, informed by dermatome and myotome mapping and lumbar segmental concepts.
Sham Thread-embedding acupunctureDevice
Sham thread-embedding acupuncture is performed bilaterally at the lumbar EX-B2 points using needles that are placed in contact with the skin at the acupuncture point sites without skin penetration. The targeted EX-B2 level is selected from L1 to L5 based on the subject's predominant pain location, guided by dermatome and myotome mapping and the principles of lumbar segmental innervation.
| Study group | Role | What they receive |
|---|---|---|
| Thread-embedding acupuncture | Experimental | Thread-embedding acupuncture and analgesic therapy Receives: Device: Thread-embedding acupuncture |
| Sham thread-embedding acupuncture | Sham comparator | Sham thread-embedding acupuncture and analgesic therapy Receives: Device: Sham Thread-embedding acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). NPRS is an 11-point numeric scale ranging from 0 to 10, where 0 = no pain and 10 = the worst pain imaginable. Higher scores indicate greater pain intensity.
Measured: Before therapy, week 2, week 4, week 6, week 8
Secondary outcomes (4)
Health-Related Quality of Life
Health-related quality of life will be assessed using the European Quality of Life 5 Dimensions 5 Levels (EQ-5D-5L) questionnaire, a standardized and validated instrument.
The EQ-5D-5L evaluates five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five levels of severity.
EQ-5D-5L Index Value:
The index score is derived from the five dimensions and typically ranges from less than 0 (health states worse than death) to 1.0 (full health), with higher scores indicating better health-related quality of life.
Measured: Before therapy (baseline), week 4, and week 8.
Frequency of Bothersome Pain Episodes
The number of days in the past 7 days during which the subject experienced bothersome low back pain.
Bothersome low back pain is defined as pain that is sufficiently significant to interfere with daily activities, rest, concentration, or overall comfort. Mild pain or pain that does not interfere with activities is not counted.
Measured: Before therapy, week 2, week 4, week 6, week 8
Frequency of Routine Analgesic Use
The number of days in the past 7 days during which the subject consumed routine analgesic medication (taken as prescribed by a physician).
Routine analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
Measured: Before therapy, week 2, week 4, week 6, week 8
Frequency of Additional (extra) Analgesic Use
The number of days in the past 7 days during which the subject consumed additional (as-needed) analgesic medication when pain remained bothersome.
Additional analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
Measured: Before therapy, week 2, week 4, week 6, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start9 Feb 2026
- Primary completion29 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- 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
- Factorial
- Model description
- Thread-embedding acupuncture and analgesic therapy will be designated as the intervention group, while sham thread-embedding acupuncture and analgesic therapy will be designated as the control group.
- 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, Atalya Vetta Widarto, Universitas Indonesia
- Investigators
- KEPK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee of Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337187
- Sponsor's protocol ID
- 25111755
- Status last verified
- Jul 2026
- First submitted
- 18 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thread-Embedding Acupuncture at EX-B2 Acupoint on Pain Intensity and Quality of Life in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07337187
- Acronym / sponsor ID
- 25111755
- Conditions
- Low Back Pain
- Keywords
- Chronic Low Back Pain, Lumbago
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 13 Jan 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.
The goal of this clinical trial is to learn whether thread-embedding acupuncture (TEA) is more effective than sham thread-embedding acupuncture in treating adults with chronic low back pain. The study will also evaluate the safety of TEA.
The main questions it aims to answer are:
- Does TEA reduce pain intensity more effectively than sham TEA?
- Does TEA improve quality of life compared with sham TEA?
- Does TEA reduce the frequency of bothersome pain episodes?
- Does TEA reduce the use of routine and additional (extra) pain medications?
- What side effects occur in participants receiving TEA compared with sham TEA?
Researchers will compare TEA with sham TEA (a procedure that mimics acupuncture without needle insertion or thread placement) to determine whether TEA provides greater and longer-lasting benefits for chronic low back pain.
Participants will:
- Receive a single session of TEA or sham TEA
- Continue using pain medications as prescribed by their physician
- Be evaluated at weeks 2, 4, 6, and 8 after treatment
- Complete pain assessments, quality-of-life questionnaires, and reports of pain episodes and medication use
- Attend in-person clinic visits at weeks 4 and 8, and receive telephone follow-ups at weeks 2 and 6
Detailed description
- In the intervention group, thread-embedding acupuncture is performed using needles containing polydioxanone (PDO) threads at the bilateral lumbar EX-B2 acupuncture points (12.5 mm lateral to the spinous process).
- In the control group, the needle is only touched to the skin at the acupuncture point area without skin penetration.
- The selection of the EX-B2 level is based on the vertebral segment from L1 to L5 that best corresponds to the subject's dominant pain location, with reference to dermatome and myotome mapping as well as the concept of lumbar segmental innervation. If available, supporting examination results (e.g., MRI or CT scan) indicating abnormalities at a specific segment are used as additional references. When more than one segment is considered possible, the midpoint level is selected.
- After completion of the study, participants in the sham thread-embedding acupuncture group are allowed to receive actual thread-embedding acupuncture therapy for chronic low back pain.
Outcome Definitions
- Bothersome pain episodes: The number of days in the past 7 days during which the subject experienced bothersome low back pain.
Bothersome low back pain is defined as pain that is sufficiently significant to interfere with daily activities, rest, concentration, or overall comfort. Mild pain or pain that does not interfere with activities is not counted.
- Frequency of routine analgesic use: The number of days in the past 7 days during which the subject consumed routine analgesic medication (taken as prescribed by a physician).
Routine analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
- Frequency of additional (rescue) analgesic use: The number of days in the past 7 days during which the subject consumed additional (as-needed) analgesic medication when pain remained bothersome.
Additional analgesics may include primary analgesics (paracetamol and/or opioids) and/or adjuvant analgesics (muscle relaxants, antiepileptics, antidepressants, antispasmodics).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Thread-embedding acupuncture and analgesic therapy will be designated as the intervention group, while sham thread-embedding acupuncture and analgesic therapy will be designated as the control group.
| Arm | Type | Receives |
|---|---|---|
| Thread-embedding acupuncture | Experimental | Device: Thread-embedding acupunctureThread-embedding acupuncture and analgesic therapy |
| Sham thread-embedding acupuncture | Sham comparator | Device: Sham Thread-embedding acupunctureSham thread-embedding acupuncture and analgesic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants aged ≥18 years
- Subjects with low back pain lasting for at least 3 months (>12 weeks)
- Maximum low back pain intensity within the past 2 weeks of ≥3 on a 0-10 scale, measured using the Numeric Pain Rating Scale (NPRS) or the Face, Legs, Activity, Cry, Consolability (FLACC) scale
- Willing to participate in the study until completion and able to provide written informed consent
- Receiving pharmacological therapy with a stable analgesic regimen for at least the past 2 weeks, which may include non-opioid analgesics (paracetamol), opioid analgesics (codeine, tramadol, morphine), antidepressants (amitriptyline, duloxetine), anticonvulsants (gabapentin, pregabalin, carbamazepine), and/or muscle relaxants (eperisone, baclofen)
Key exclusion criteria (13 listed)
- History of hypersensitivity to acupuncture or thread-embedding acupuncture (TEA), including allergy to stainless steel or polydioxanone threads
- History of keloid formation or skin disorders at the planned TEA insertion sites in the low back area
- Presence of specific spinal pathology, including fracture, tumor, infection, or severe lumbar spinal stenosis (Schizas grade C or D) requiring surgical intervention
- Structural spinal abnormalities (scoliosis or kyphosis) detected on physical examination
- History of spinal surgery or current indication for spinal surgery due to severe neurological deficits
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 acupunctureThread-embedding acupuncture is performed bilaterally at a pair of lumbar EX-B2 points using needles containing polydioxanone (PDO) threads, positioned 12.5 mm lateral to the spinous processes. The targeted EX-B2 level is selected from L1 to L5 based on the subject's main pain location, informed by dermatome and myotome mapping and lumbar segmental concepts. | Device | Thread-embedding acupuncture |
| Sham Thread-embedding acupunctureSham thread-embedding acupuncture is performed bilaterally at the lumbar EX-B2 points using needles that are placed in contact with the skin at the acupuncture point sites without skin penetration. The targeted EX-B2 level is selected from L1 to L5 based on the subject's predominant pain location, guided by dermatome and myotome mapping and the principles of lumbar segmental innervation. | Device | Sham thread-embedding acupuncture |
Primary outcome
Pain Intensity
Time frame: Before therapy, week 2, week 4, week 6, week 8
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS). NPRS is an 11-point numeric scale ranging from 0 to 10, where 0 = no pain and 10 = the worst pain imaginable. Higher scores indicate greater pain intensity.
4 secondary outcomes
Health-Related Quality of Life
Time frame: Before therapy (baseline), week 4, and week 8.
Frequency of Bothersome Pain Episodes
Time frame: Before therapy, week 2, week 4, week 6, week 8
Frequency of Routine Analgesic Use
Time frame: Before therapy, week 2, week 4, week 6, week 8
Frequency of Additional (extra) Analgesic Use
Time frame: Before therapy, week 2, week 4, week 6, 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 13 Jul 2026.
- Individual participant dataSharing planned: No
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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
The Health Research Ethics Commitee of Faculty of Medicine
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 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 5 inclusion and 13 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 13 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?
Pain Intensity (time frame: Before therapy, week 2, week 4, week 6, 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 13 Jul 2026.