Effect of Low-Dose Laser Acupuncture on Low Back Pain: A Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain intensity (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Sham Laser Acupuncture (Device)
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.
干预措施: Low-Dose Laser Acupuncture (Device)
结局指标
主要结局
Pain intensity (VAS)
时间窗: 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.
Pain intensity measured by a visual analog scale (VAS), 0-10 cm (0 = no pain; 10 = worst pain).
Global Assessment of Pain
时间窗: 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.
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).
Functional disability (ODI)
时间窗: 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 measured by the Oswestry Disability Index (ODI); total score will be reported per instrument scoring.
Functional disability (RMDQ)
时间窗: 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 measured by the Roland-Morris Disability Questionnaire (RMDQ); total score will be reported per instrument scoring.
次要结局
- 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).)
研究者
Mun Fei Yam
Principal Investigator
Universiti Sains Malaysia