Effect of Thread-Embedding Acupuncture at EX-B2 on Pain and Quality of Life in Chronic Low Back Pain

NCT07337187 | Not Yet Recruiting

• 1 other identifier: 25111755
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Low Back Pain

Keywords

Chronic Low Back Pain; Lumbago

Outcome Measures

Primary Outcomes (1)

• 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.

  Before therapy, week 2, week 4, week 6, week 8

Secondary Outcomes (4)

• Health-Related Quality of Life

  Before therapy (baseline), week 4, and week 8.

• Frequency of Bothersome Pain Episodes

  Before therapy, week 2, week 4, week 6, week 8

• Frequency of Routine Analgesic Use

  Before therapy, week 2, week 4, week 6, week 8

• Frequency of Additional (extra) Analgesic Use

  Before therapy, week 2, week 4, week 6, week 8

Study Arms (2)

Thread-embedding acupuncture

EXPERIMENTAL

Thread-embedding acupuncture and analgesic therapy

Device: Thread-embedding acupuncture

Sham thread-embedding acupuncture

SHAM COMPARATOR

Sham thread-embedding acupuncture and analgesic therapy

Device: Sham Thread-embedding acupuncture

Interventions

Sham Thread-embedding acupuncture DEVICE

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.

Sham thread-embedding acupuncture

Thread-embedding acupuncture DEVICE

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.

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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• KEPK FKUI-RSCM

  The Health Research Ethics Commitee of Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atalya Vetta Widarto, MD

CONTACT

+6281510079735; atalya.vetta@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: the participants and the outcome assessors will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: 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.

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)