Chronic Low Back PainNCT07461363
Efficacy of Low-Dose Laser Acupuncture for Low Back Pain
A study testing Low-Dose Laser Acupuncture in people with Chronic Low Back Pain, run by Mun Fei Yam at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Low-Dose Laser Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2026to 15 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
About this study
Official title: Effect of Low-Dose Laser Acupuncture on Low Back Pain: A Randomised Control Trial
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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Low-Dose Laser Acupuncture, Sham Laser Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose Laser AcupunctureDevice
Also called LLLT
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).
Sham Laser AcupunctureDevice
Also called Placebo 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Low-Dose Laser Acupuncture |
| 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). Receives: Device: Sham Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (VAS)
Pain intensity measured by a visual analog scale (VAS), 0-10 cm (0 = no pain; 10 = worst pain).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Secondary outcomes (5)
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.
Measured: 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)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Sep 2026 (estimated)
- Primary completion15 Feb 2028 (estimated)
- Study completion15 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mun Fei Yam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mun Fei Yam, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461363
- Sponsor's protocol ID
- EC-025-663
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low-Dose Laser Acupuncture on Low Back Pain: A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07461363
- Acronym / sponsor ID
- EC-025-663
- Conditions
- Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mun Fei YamUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 15 Feb 2028 (estimated)
- Study completion
- 15 Aug 2028 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Low-Dose Laser Acupuncture | Experimental | Device: Low-Dose Laser AcupunctureParticipants 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. |
| Sham (Placebo) Laser Acupuncture | Sham comparator | Device: Sham Laser AcupunctureParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Dose Laser AcupunctureAlso: LLLTLow-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). | Device | Active Low-Dose Laser Acupuncture |
| Sham Laser AcupunctureAlso: Placebo Laser AcupunctureSham 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. | Device | Sham (Placebo) Laser Acupuncture |
Primary outcome
Pain intensity (VAS)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Sustained pain intensity at 3 months (VAS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Dose Laser Acupuncture in people with Chronic Low Back Pain, run by Mun Fei Yam at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact QIYUE QIU (+86-13945367999, qiuqiyue99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (VAS) (time frame: 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.