Efficacy of Low-Dose Laser Acupuncture for Low Back Pain

NCT07461363 | Enrolling By Invitation DMC

• 1 other identifier: EC-025-663
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether low-dose laser acupuncture can reduce pain and improve daily function in adults with chronic low back pain. The trial is a double-blinded, randomized, two-arm, parallel, multi-centred study.

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (4)

• Pain intensity (VAS)

  Pain intensity measured by a visual analog scale (VAS), 0-10 cm (0 = no pain; 10 = worst pain).

  Baseline (Visit 1, Week 1); End of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment.

• Global Assessment of Pain

  Participant global assessment of pain change compared with the previous visit (7-point scale: much worse, worse, slightly worse, no change, slightly better, better, much better).

  Visit 2 through end of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment.

• Functional disability (ODI)

  Functional disability measured by the Oswestry Disability Index (ODI); total score will be reported per instrument scoring.

  Baseline (Visit 1, Week 1); End of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment.

• Functional disability (RMDQ)

  Functional disability measured by the Roland-Morris Disability Questionnaire (RMDQ); total score will be reported per instrument scoring.

  Baseline (Visit 1, Week 1); End of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment.

Secondary Outcomes (5)

• Sustained pain intensity at 3 months (VAS)

  3 months after completion of treatment (phone follow-up conducted 3 months after Visit 6 or Visit 12, whichever is the participant's last treatment visit).

• Sustained functional disability at 3 months (ODI)

  3 months after completion of treatment (phone follow-up conducted 3 months after Visit 6 or Visit 12, whichever is the participant's last treatment visit).

• Sustained pain improvement at 3 months (Global Assessment of Pain)

  3 months after completion of treatment (phone follow-up conducted 3 months after Visit 6 or Visit 12, whichever is the participant's last treatment visit).

• Safety profile (adverse events)

  Visit 1 (Week 1) through end of treatment (Visit 6 at Week 3 or Visit 12 at Week 6, whichever is the participant's last treatment visit); 3 months after end of treatment (phone follow-up).

• Patient acceptance of laser acupuncture

  After each treatment session during the treatment period: after Visits 1-6 (Weeks 1-3) and, if applicable, after Visits 7-12 (Weeks 4-6).

Study Arms (2)

Active Low-Dose Laser Acupuncture

EXPERIMENTAL

Participants receive low-dose laser acupuncture using laser modules taped to 10 predefined acupoints. Active laser is delivered at the protocol-specified dose (4.19 J/cm³) according to the treatment schedule.

Device: Low-Dose Laser Acupuncture

Sham (Placebo) Laser Acupuncture

SHAM COMPARATOR

Participants receive a sham laser acupuncture procedure with laser modules taped to the same 10 acupoints and the same schedule as the active group, but the laser is not activated (no laser energy delivered).

Device: Sham Laser Acupuncture

Interventions

Low-Dose Laser Acupuncture DEVICE

Low-dose laser acupuncture delivered using an AlGaAs laser device (Aculas-AM-100 Multi-channel Digital LLLT System; 780 nm; 80 mW). Laser modules are taped to 10 bilateral acupoints. Active laser dose is 4.19 J/cm³ delivered over 20 minutes (1200 s) with a 3 cm² treatment area. Core acupoints: BL23, BL24, BL25, BL40; optional (one pair) for concomitant pain: BL17 or BL52 or BL37. Up to 6 sessions (week 3) with option to continue to 12 sessions (week 6).

Also known as: LLLT

Active Low-Dose Laser Acupuncture

Sham Laser Acupuncture DEVICE

Sham laser acupuncture: laser modules are taped to the same 10 bilateral acupoints and sessions follow the same schedule as the active group, but the laser is not activated (no laser energy delivered). Participants cannot see the modules/machine while lying face down.

Also known as: Placebo Laser Acupuncture

Sham (Placebo) Laser Acupuncture

Eligibility Criteria

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

You may qualify if:

• Low back pain for ≥12 weeks
• Pain intensity VAS ≥3 cm at Visit 1 (baseline)
• Age 18-65 years
• Able and willing to provide written informed consent
• Able and willing to attend treatment sessions at Pusat Sejahtera, Universiti Sains Malaysia and complete the 3-month follow-up phone assessment

You may not qualify if:

• Pregnant or planning pregnancy; females unwilling to use pregnancy prevention during the study
• Current or past history of trauma or cancer
• Prior spine surgery
• Severe infection (e.g., tuberculosis, pyogenic abscess)
• Fever ≥38°C lasting ≥48 hours at recruitment
• Cauda equina syndrome
• Significant spinal cord compression with serious disability (per medical history)
• Osteoporosis requiring pharmacologic treatment
• Severe dementia, cognitive impairment, other major cerebral disease, or severe psychiatric/psychological disorder
• Significant renal or hepatic disease
• BMI ≥34.9 kg/m²
• History of recreational drug abuse
• Use of systemic steroids within the past 6 months
• Use of any analgesics (including paracetamol) within the past 30 days
• Acupuncture treatment within the past 30 days

Sponsors & Collaborators

• Mun Fei Yam: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

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

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: March 10, 2026
• Study Start: November 1, 2025
• Primary Completion: April 15, 2026
• Study Completion: May 15, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)