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Non-specific Low Back PainLATLBPNCT07826117

Laser Acupuncture Versus Traditional Acupuncture for Chronic Low Back Pain

A study testing Laser Acupuncture and Traditional Acupuncture in people with Non-specific Low Back Pain and Acupuncture, run by China Medical University Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 60 years
What is being tested?
Laser Acupuncture and Traditional Acupuncture
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
No sites listed yet
Study dates
15 Sep 2026to 15 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Clinical diagnosis of chronic low back pain
  • Low back pain located between the 12th rib and the gluteal fold, persisting for 3 months or longer
  • Age between 20 and 60 years
  • No sciatica or other neurological diseases
  • No systemic musculoskeletal or joint diseases, such as rheumatoid arthritis
  • No dependence on regular analgesic use
  • Numeric Pain Rating Scale (NPRS) score ≥4

Who cannot join

  • Spinal tumors
  • Osteoporosis
  • Lumbar spinal stenosis
  • Lumbar spondylolisthesis
  • Ankylosing spondylitis
  • Piriformis syndrome
Show all 15Show fewer
  • Vertebral fracture within the past year
  • Lumbar spine surgery within the past 3 months
  • Spinal infection or active inflammatory disease
  • Coagulation disorders or current use of anticoagulant medications
  • 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
  • Systemic inflammatory skin diseases or infectious diseases
  • Known pregnancy

About this study

Official title: Evaluation of the Therapeutic Effects of Laser Acupuncture and Traditional Acupuncture: A Study of Chronic Non-Specific 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.

Read more

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.

Being tested
Laser Acupuncture, Traditional Acupuncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laser AcupunctureDevice

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

  • Traditional AcupunctureOther

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

Study groups in NCT07826117
Study groupRoleWhat they receive
Laser AcupunctureExperimentalNot described
Receives: Device: Laser Acupuncture
Traditional AcupunctureActive comparatorNot described
Receives: Other: Traditional Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fingertip-to-floor distance

    Measured: Baseline,3 weeks,6 weeks,8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study start15 Sep 2026 (estimated)
  3. Primary completion15 Sep 2027 (estimated)
  4. Study completion15 Sep 2028 (estimated)

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07826117
Sponsor's protocol ID
CMUH115-REC1-149
Acronym
LATLBP
Status last verified
Sep 2026
First submitted
12 Sep 2026
Last updated
23 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Laser Acupuncture and Traditional Acupuncture in people with Non-specific Low Back Pain and Acupuncture, run by China Medical University Hospital.

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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

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?

Fingertip-to-floor distance (time frame: Baseline,3 weeks,6 weeks,8 weeks). 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 23 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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