Thread-embedding Combined With Auricular Acupuncture for Non-specific Chronic Low Back Pain

NCT06682273 | Completed

• 1 other identifier: 273HDDD-GD
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain (LBP) is a significant global health issue, with cases expected to rise by 36.4% by 2050. Chronic LBP (cLBP), lasting over three months, is mostly non-specific cLBP (cNLBP), posing a challenge for effective management. Common treatments include medication, exercise, and acupuncture. This study explores the combined use of thread-embedding and auricular acupuncture for treating cNLBP, as combining these methods is thought to enhance effectiveness. Participants with cNLBP will be randomized into four groups to receive either the combination of both treatments, each treatment individually with a sham, or both shams. The study will last eight weeks, with four weeks of intervention and four weeks of follow-up. Treatment outcomes, including pain, disability, medication use, and quality of life, will be evaluated, along with monitoring for adverse effects.

Conditions

Chronic Non-Specific Low Back Pain

Keywords

acupuncture; thread embedding acupuncture; auricular acupuncture; low back pain; traditional medicine

Outcome Measures

Primary Outcomes (1)

• Change in Oswestry Disability Index (ODI) percentage score

  The Oswestry Disability Index (ODI) percentage score evaluates the impact of low back pain on various activities (sleeping, self-care, sex life, social life, and traveling) using six rating options (0 to 5). Participants select the most appropriate response, and the total score is calculated as a percentage of the maximum possible score (50 if all sections are completed). A score of zero indicates no disability, while a score of 100% implies significant disability.

  Week 0, Week 2, Week 4, Week 6, and Week 8

Secondary Outcomes (5)

• Change in pain score on the Numeric Rating Scale (NRS)

  Week 0, Week 2, Week 4, Week 6, and Week 8

• Change in the number of paracetamol tablets used

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

• Change in the Patient-Reported Outcomes Measurement Information System Global Health 10 (PROMIS-GH-10) score

  Week 0, Week 2, Week 4, Week 6, and Week 8

• Global improvement rate

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

• Proportion of intervention-related adverse events

  Up to eight weeks

Study Arms (4)

TEA + AA

EXPERIMENTAL

Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with auricular acupuncture (AA) every week in 4 weeks (4 sessions).

Other: Thread-embedding acupuncture; Other: Auricular acupuncture

TEA + sham AA

ACTIVE COMPARATOR

Thread-embedding acupuncture (TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions).

Other: Thread-embedding acupuncture; Other: Sham auricular acupuncture

AA + sham TEA

ACTIVE COMPARATOR

Auricular acupuncture (AA) every week in 4 weeks (4 sessions). Combined with sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions).

Other: Auricular acupuncture; Other: Sham thread-embedding acupuncture

Sham both

SHAM COMPARATOR

Sham thread-embedding acupuncture (sham TEA) every week in 4 weeks (4 sessions). Combined with sham auricular acupuncture (sham AA) every week in 4 weeks (4 sessions).

Other: Sham thread-embedding acupuncture; Other: Sham auricular acupuncture

Interventions

Thread-embedding acupuncture OTHER

Thread-embedding acupuncture is performed every week for 4 weeks, using a single Polydioxaone thread inserted into acupoints on the body through the needle. After the thread is inserted, the needle will be immediately withdrawn.

TEA + AA; TEA + sham AA

Auricular acupuncture OTHER

Auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into therapeutic points on the ear. The patches with the needle will remain in place for one week.

AA + sham TEA; TEA + AA

Sham thread-embedding acupuncture OTHER

Sham thread-embedding acupuncture is performed every week for 4 weeks, using the needle without thread inserted into acupoints on the body. After insertion, the needle will be immediately withdrawn, and no thread will be left in the body.

AA + sham TEA; Sham both

Sham auricular acupuncture OTHER

Sham auricular acupuncture is conducted weekly for 4 weeks using patches, each with a square shape and a side length of 10 mm, along with a sterilized needle measuring 0.25 x 1.3 mm inserted into non-therapeutic points on the ear. The patches with the needle will remain in place for one week.

Sham both; TEA + sham AA

Eligibility Criteria

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

You may qualify if:

• Patients with low back pain at the outpatient clinic.
• Diagnosed with non-specific low back pain persisting for more than 3 months, without radiation to the legs.
• Pain-NRS score ≥ 4 on a 10-point scale.
• Independent ambulation capability (with or without walking aids).
• Consent to participate in the study.

You may not qualify if:

• History of prior lumbar spine surgery.
• Known or suspected severe spinal conditions (e.g., cancer, vertebral fracture, spinal infection, or cauda equina syndrome).
• Signs of concurrent involvement of lumbar nerve roots, plexus, sciatic nerve, other leg nerves, or diagnosed polyneuropathy confirmed by electrodiagnosis.
• Presence of systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis.
• Unstable or untreated severe health conditions (such as end-stage renal disease, advanced liver failure, NYHA class IV heart failure).
• Alcohol abuse or substance dependence.
• Use of anti-inflammatory medication within 2 weeks prior to enrollment.
• Acupuncture treatment within the past 4 weeks.
• Previous treatment with thread-embedding or auricular acupuncture for any condition.
• Damaged skin in the acupuncture area or history of hypersensitivity reactions to acupuncture.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

Nhan Dan Gia Dinh Hospital

Ho Chi Minh City, 700000, Vietnam

Location

Related Publications (6)

• Hunter RF, McDonough SM, Bradbury I, Liddle SD, Walsh DM, Dhamija S, Glasgow P, Gormley G, McCann SM, Park J, Hurley DA, Delitto A, Baxter GD. Exercise and Auricular Acupuncture for Chronic Low-back Pain: A Feasibility Randomized-controlled Trial. Clin J Pain. 2012 Mar-Apr;28(3):259-67. doi: 10.1097/AJP.0b013e3182274018.

  PMID: 21753728 BACKGROUND

• Lee HJ, Choi BI, Jun S, Park MS, Oh SJ, Lee JH, Gong HM, Kim JS, Lee YJ, Jung SY, Han CH. Efficacy and safety of thread embedding acupuncture for chronic low back pain: a randomized controlled pilot trial. Trials. 2018 Dec 12;19(1):680. doi: 10.1186/s13063-018-3049-x.

  PMID: 30541604 BACKGROUND

• Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

  PMID: 11074683 BACKGROUND

• Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J. 2010 Sep;19(9):1484-94. doi: 10.1007/s00586-010-1353-6. Epub 2010 Apr 17.

  PMID: 20397032 BACKGROUND

• Haefeli M, Elfering A. Pain assessment. Eur Spine J. 2006 Jan;15 Suppl 1(Suppl 1):S17-24. doi: 10.1007/s00586-005-1044-x. Epub 2005 Dec 1.

  PMID: 16320034 BACKGROUND

• Pham TL, Le NT, Nguyen TT, Chu H. Should thread-embedding and auricular acupuncture be combined rather than used individually for non-specific chronic low back pain?: A double-blinded, randomized, sham-controlled trial. Integr Med Res. 2025 Sep;14(3):101180. doi: 10.1016/j.imr.2025.101180. Epub 2025 Jun 13.

  PMID: 40689022 DERIVED

MeSH Terms

Conditions

Low Back Pain

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: November 11, 2024
• Primary Completion: February 20, 2025
• Study Completion: March 20, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

VN (1)