Laser Acupuncture Versus Traditional Acupuncture for Chronic Low Back Pain

NCT07826117 | Not Yet Recruiting

• 1 other identifier: CMUH115-REC1-149
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Non-specific Low Back Pain; Acupuncture; Laser Acupuncture

Outcome Measures

Primary Outcomes (1)

• Fingertip-to-floor distance

  Baseline,3 weeks,6 weeks,8 weeks

Study Arms (2)

Laser Acupuncture

EXPERIMENTAL

Device: Laser Acupuncture

Traditional Acupuncture

ACTIVE COMPARATOR

Other: Traditional Acupuncture

Interventions

Laser Acupuncture DEVICE

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

Laser Acupuncture

Traditional Acupuncture OTHER

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

Traditional Acupuncture

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Spinal tumors
• Osteoporosis
• Lumbar spinal stenosis
• Lumbar spondylolisthesis
• Ankylosing spondylitis
• Piriformis syndrome
• 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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Acupunture

Study Record Dates

• First Submitted: September 12, 2026
• First Posted: September 17, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09