Enrolling by invitation NCT07461363
Efficacy of Low-Dose Laser Acupuncture for Low Back Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low-Dose Laser Acupuncture, Sham Laser Acupuncture.
- Who it may be relevant to
- Registry conditions: Chronic Low Back Pain. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effect of Low-Dose Laser Acupuncture on Low Back Pain: A Randomised Control Trial
Overview
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.
Interventions
- 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). - 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.
Primary outcome measures
- Pain intensity (VAS) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: 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 (5)
- Sustained pain intensity at 3 months (VAS) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: 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).]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Xinxiang Medical University — Xinxiang
Identifiers
NCT: NCT07461363 · EC-025-663