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NCT07461363
Efficacy of Low-Dose Laser Acupuncture for Low Back Pain
Conditions: Chronic Low Back Pain
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Mun Fei Yam
Location: The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
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.
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
Source: ClinicalTrials.gov (NCT07461363). StuddyBuddy aggregates publicly available trial information.