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.
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
- Conditions the study is for
- Non-specific Low Back Pain, Acupuncture, Laser Acupuncture
- 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
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- 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.
- Conditions
- Non-specific Low Back Pain, Acupuncture, Laser Acupuncture
- 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 group | Role | What they receive |
|---|---|---|
| Laser Acupuncture | Experimental | Not described Receives: Device: Laser Acupuncture |
| Traditional Acupuncture | Active comparator | Not described Receives: Other: Traditional Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted17 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Effects of Laser Acupuncture and Traditional Acupuncture: A Study of Chronic Non-Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT07826117
- Acronym / sponsor ID
- LATLBP / CMUH115-REC1-149
- Conditions
- Non-specific Low Back Pain, Acupuncture, Laser Acupuncture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Sep 2028 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture | Experimental | Device: Laser Acupuncture |
| Traditional Acupuncture | Active comparator | Other: Traditional Acupuncture |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- Spinal tumors
- Osteoporosis
- Lumbar spinal stenosis
- Lumbar spondylolisthesis
- Ankylosing spondylitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser AcupunctureLow-level laser therapy applied to specific acupuncture points for chronic non-specific low back pain. | Device | Laser Acupuncture |
| Traditional AcupunctureManual acupuncture using sterile acupuncture needles inserted into specific acupuncture points. | Other | Traditional Acupuncture |
Primary outcome
Fingertip-to-floor distance
Time frame: Baseline,3 weeks,6 weeks,8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.