Efficacy of Low-Dose Laser Acupuncture for Low Back Pain

Effect of Low-Dose Laser Acupuncture on Low Back Pain: A Randomised Control Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: Low-Dose Laser Acupuncture; Device: Sham Laser Acupuncture

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Xinxiang, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Low-Dose Laser Acupuncture; 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; 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).; Other Names: LLLT
Sham Comparator: Sham (Placebo) Laser Acupuncture; 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; 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.; Other Names: Placebo Laser Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sustained pain intensity at 3 months (VAS)	Pain intensity measured by VAS, 0-10 cm (0 = no pain; 10 = worst pain) at the 3-month follow-up phone call.	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)	Functional disability measured by the Oswestry Disability Index (ODI) at the 3-month follow-up phone call; total score will be reported per instrument scoring.	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)	Participant global assessment of pain status at the 3-month follow-up phone call (7-point scale: much worse, worse, slightly worse, no change, slightly better, better, much better).	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)	Adverse events will be assessed using a standard non-leading question at each treatment visit and at the 3-month post-treatment phone follow-up. Events will be recorded and classified by intensity (mild/moderate/severe) and by assessed relationship to study treatment (e.g., very likely to very unlikely). Serious adverse events will be documented and reported per protocol procedures.	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	Patient acceptance will be evaluated using a brief acceptance questionnaire administered after each laser acupuncture treatment session (patient feedback recorded after each session).	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).

Collaborators and Investigators

• Sponsor: Mun Fei Yam

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): April 15, 2026
• Study Completion (Estimated): May 15, 2026

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: EC-025-663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified individual participant data (IPD) will not be shared due to participant privacy considerations and local institutional/ethics restrictions. Aggregate results will be reported in publications and on ClinicalTrials.gov.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No