Chronic Low Back Pain
Conditions
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.
Interventions
DEVICELow-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).
DEVICESham 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.
Sponsors
Mun Fei Yam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (VAS) | 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 | 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) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Pain intensity measured by VAS, 0-10 cm (0 = no pain; 10 = worst pain) at the 3-month follow-up phone call. |
| 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). | 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. |
| 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). | 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). |
| 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). | 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. |
| 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). | Patient acceptance will be evaluated using a brief acceptance questionnaire administered after each laser acupuncture treatment session (patient feedback recorded after each session). |
Countries
China
Contacts
CONTACTQIYUE QIU
Outcome results
None listed