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NCT Number: NCT07826117

Laser Acupuncture Versus Traditional Acupuncture for Chronic Low Back Pain

Chronic nonspecific low back pain is a common condition that may cause persistent pain and limitations in daily activities. This study aims to compare the therapeutic effects of traditional acupuncture and laser acupuncture in patients with chronic nonspecific low back pain, focusing on pain, functional disability, and flexibility.

Approximately 60 participants aged 20-60 years with low back pain between the 12th rib and gluteal fold lasting at least three months will be recruited. Participants must have a Numeric Pain Rating Scale (NPRS) score of at least 4 and meet the study eligibility criteria. Individuals with conditions such as sciatica, neurological disease, spinal tumor, osteoporosis, lumbar spinal stenosis, lumbar spondylolisthesis, ankylosing spondylitis, piriformis syndrome, recent vertebral fracture or lumbar surgery, spinal infection, coagulation disorders, anticoagulant use, long-term corticosteroid use, cauda equina symptoms, severe systemic disease, active inflammatory or infectious skin disease, or known pregnancy will be excluded.

Before participation, the research team will explain the study procedures, possible risks and benefits, and participants' rights. After providing informed consent and completing screening, eligible participants will be randomly assigned in a 1:1 ratio to either the traditional acupuncture group or the laser acupuncture group. Participants cannot choose their treatment group.

Both groups will receive treatment twice a week for six weeks, for a total of 12 sessions, with each session lasting approximately 20 minutes. The same nine acupuncture points will be used: bilateral BL20 (Pishu), GV3 (Yaoyangguan), bilateral GB30 (Huantiao), bilateral GB34 (Yanglingquan), and bilateral BL25 (Dachangshu). The traditional acupuncture group will receive sterile, single-use needles inserted by an experienced physician and manipulated to produce the intended acupuncture sensation. The laser acupuncture group will receive laser stimulation at the same acupuncture points without needle insertion. The study protocol uses a Handylaser Trion device with an 810-nm wavelength, an energy density of 7.96 J/cm², and approximately 20 seconds of stimulation per point.

Participants will be assessed at baseline, week 3, week 6, and week 8. The primary outcome is the modified Oswestry Disability Index (mODI), which evaluates disability related to low back pain. Secondary outcomes include pain intensity measured by the NPRS and flexibility measured by fingertip-to-floor distance. Week 8 serves as a short-term follow-up approximately two weeks after treatment completion. Changes in these outcomes will be compared between the two treatment groups.

Participants may experience improvement in pain or physical function, although benefits cannot be guaranteed. Traditional acupuncture may cause temporary discomfort, soreness, minor bleeding, or bruising. Laser acupuncture does not involve needle insertion and may provide a less invasive treatment experience. Participants will be monitored for discomfort or adverse events throughout the study.

Participation is voluntary, and participants may withdraw at any time without penalty or loss of appropriate medical care. Personal and medical information will be kept confidential and used for research purposes. The study will be conducted according to applicable ethical standards, including the Declaration of Helsinki and ICH-GCP.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Outpatients diagnosed with chronic low back pain will be screened for eligibility for participation in this study. The inclusion criteria are as follows: (1) low back pain (LBP) located between the 12th rib and the gluteal fold, with pain persisting for 3 months or longer; (2) age between 20 and 60 years; (3) no sciatica or other neurological diseases; (4) no systemic musculoskeletal or joint diseases, such as rheumatoid arthritis; (5) no dependence on regular analgesic use; and (6) a Numeric Pain Rating Scale (NPRS) score of ≥4.

Exclusion criteria

  • The exclusion criteria include the presence of spinal tumors, osteoporosis, lumbar spinal stenosis, lumbar spondylolisthesis, ankylosing spondylitis, or piriformis syndrome; a history of vertebral fracture within the past year or lumbar spine surgery within the past 3 months; spinal infection or active inflammatory disease; coagulation disorders or current use of anticoagulant medications, as well as long-term use of systemic corticosteroids; signs or symptoms of cauda equina syndrome, such as bowel or bladder dysfunction; severe comorbidities, such as cancer, heart disease, or psychiatric disorders, as well as systemic inflammatory skin diseases or infectious diseases; and known pregnancy.

Treatment and study plan

Laser acupuncture

Device

Low-level laser therapy applied to specific acupuncture points for chronic non-specific low back pain.

Traditional Acupuncture

Other

Manual acupuncture using sterile acupuncture needles inserted into specific acupuncture points.

Primary outcomes

  1. Fingertip-to-floor distance

    Time frame: Baseline,3 weeks,6 weeks,8 weeks

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Official study title

Evaluation of the Therapeutic Effects of Laser Acupuncture and Traditional Acupuncture: A Study of Chronic Non-Specific Low Back Pain

Acronym: LATLBP

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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