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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Low-Dose Laser Acupuncture | Experimental | 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. |
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| Sham (Placebo) Laser Acupuncture | Sham Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-Dose Laser Acupuncture | Device | 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). |
| 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. |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xinxiang Medical University | Xinxiang | Henan | 453100 | China |
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.
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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| Sham Laser Acupuncture | Device | 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. |
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| 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). |