Efficacy of Low-Dose Laser Acupuncture for Low Back Pain (NCT07461363) | Clinical Trial Compass
By InvitationNot Applicable
Efficacy of Low-Dose Laser Acupuncture for Low Back Pain
China80 participantsStarted 2025-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain intensity (VAS)
Timeframe: 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.
2
Global Assessment of Pain
Timeframe: 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.
3
Functional disability (ODI)
Timeframe: 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.
4
Functional disability (RMDQ)
Timeframe: 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.