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

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:

• 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

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Device: Thread-embedding acupuncture; Device: Sham Thread-embedding acupuncture

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 Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Atalya Vetta Widarto, MD; Phone Number: +6281510079735; Email: atalya.vetta@ui.ac.id

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Universitas Indonesia
      • Contact: Atalya Vetta Widarto, MD; Phone Number: +6281510079735; Email: atalya.vetta@ui.ac.id

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thread-embedding acupuncture; Thread-embedding acupuncture and analgesic therapy	Device: Thread-embedding acupuncture; 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 Comparator: Sham thread-embedding acupuncture; Sham thread-embedding acupuncture and analgesic therapy	Device: Sham Thread-embedding acupuncture; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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).	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).	Before therapy, week 2, week 4, week 6, week 8

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: KEPK FKUI-RSCM, The Health Research Ethics Commitee of Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Lumbago; Chronic Low Back Pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: 25111755

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No