An interventional study of Electroacupuncture and Intravascular Low-Level Laser Therapy (ILIB) in Sleep Disorders and Sciatica, sponsored by Le Hoang Minh Quan. Completed at 1 site in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Le Hoang Minh Quan · Not applicable, Interventional, and Treatment
Sciatica is a common condition worldwide, with prevalence rates ranging from 1.2% to 43%. Chronic sciatica is often associated with sleep disturbances, forming a bidirectional loop where persistent nociceptive input disrupts sleep continuity, and sleep deprivation amplifies mechanical pain sensitivity. According to institutional records, sciatica accounts for approximately 26% of hospital admissions for musculoskeletal disorders at regional rehabilitation centers. Current pharmacological options for sleep fragmentation provide limited benefits and carry risks of tolerance or dependence, making integrative, non-pharmacologic frameworks important.
Intravascular laser irradiation of blood (ILIB), or intravascular photobiomodulation, is a minimally invasive therapy delivering low-level red laser light (630 nm) into the venous circulation to downregulate systemic inflammation and improve microcirculation. This randomized controlled pilot study evaluates the operational feasibility and preliminary clinical trends of combining ILIB with standardized electroacupuncture. Sixty-six participants are randomly assigned to two parallel arms: a control group receiving electroacupuncture alone (n = 33) and an intervention group receiving combined ILIB and electroacupuncture (n = 33). Active treatment is administered daily for 10 sessions over 2 consecutive weeks. Clinical and behavioral parameters are tracked via the Pittsburgh Sleep Quality Index (PSQI), Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), Epworth Sleepiness Scale (ESS), and patient medication diaries at baseline, Day 7, Day 15, and an exploratory post-treatment follow-up on Day 22.
Sciatica, characterized by radiating pain along the sciatic nerve, is one of the most common causes of chronic low back pain. The condition affects approximately 13%-40% of adults globally and remains a major contributor to disability, reduced productivity, and impaired quality of life. In Vietnam, hospital-based surveys have reported that sciatica accounts for 12%-26% of inpatient admissions in traditional medicine and rehabilitation facilities.
Chronic musculoskeletal pain such as sciatica is frequently associated with sleep disorders. Studies indicate that up to 70% of patients with chronic pain experience poor sleep quality, and the relationship between pain and sleep is bidirectional: persistent pain interferes with sleep continuity, while sleep deprivation increases pain sensitivity and emotional distress. Conventional pharmacologic treatments for insomnia (such as benzodiazepines or non-benzodiazepine hypnotics) often provide temporary relief but may cause tolerance, dependence, or adverse cognitive effects. Consequently, non-pharmacologic and integrative approaches are increasingly emphasized in chronic pain management.
Intravascular photobiomodulation (ILIB), also referred to as intravascular laser irradiation of blood, is a minimally invasive technique that introduces low-level laser light (typically 630-650 nm) into the venous circulation. The photobiological effects of ILIB include enhanced oxygen transport, improved microcirculation, modulation of oxidative stress, and anti-inflammatory action. Clinical studies have demonstrated ILIB's potential in various chronic diseases, including musculoskeletal pain, vascular disorders, and metabolic dysfunctions. Preliminary evidence also suggests that ILIB may enhance sleep quality through regulation of circadian and autonomic function.
This randomized controlled pilot study was designed to evaluate the short-term efficacy of ILIB combined with electroacupuncture in improving pain and sleep quality in patients with chronic sciatica. The trial was conducted at the Binh Dinh Hospital of Traditional Medicine and Rehabilitation, Vietnam, from January to December 2025.
A total of 66 patients aged 18 years or older, diagnosed with chronic sciatica (pain duration ≥ 3 months) and sleep disturbance (Pittsburgh Sleep Quality Index > 5), were recruited and randomly assigned to one of two groups:
To control for pharmacological confounding factors, participants were restricted from modifying baseline drug therapies or initiating non-protocol physical modalities. Permitted rescue analgesic medication was restricted to paracetamol (maximum 2 g/day), tracked quantitatively via daily patient compliance diaries. Outcome measures were logged across four temporal milestones: baseline (Day 0), Day 7, Day 15, and an exploratory post-treatment follow-up on Day 22 to examine short-term carry-over retention after treatment withdrawal. Longitudinal data analysis was performed using linear mixed-effects regression models to handle repeated measurements while protecting statistical transparency.
747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.
This study's enrollment of 66 is close to the median of 66 across 531 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →This is the only study on the registry with Le Hoang Minh Quan as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Participants in this group receive combined electroacupuncture and intravascular laser irradiation of blood (ILIB). * Electroacupuncture: Performed once daily for 10 consecutive days at a frequency of 60 Hz, 20 minutes per session. Acupuncture points include Jiaji (L3-S1), Dachangshu (BL25), Huantiao (GB30), Yinmen (BL37), Yanglingquan (GB34), Chengfu (BL36), Chengshan (BL57), and Kunlun (BL60). * Intravascular Laser Therapy: A sterile intravenous needle is inserted into a peripheral vein, and a laser fiber (630-650 nm, low-level laser) is introduced through the same entry site. The laser is connected to the laser source, delivering photobiomodulation for 30 minutes per session, 5 sessions per week, for 2 consecutive weeks (total 10 sessions). Intervention Name: * Procedure: Electroacupuncture * Device: Intravascular Low-Level Laser Therapy (ILIB)
Procedure: Electroacupuncture · Device: Intravascular Low-Level Laser Therapy (ILIB)
Participants in this group receive electroacupuncture only. * Electroacupuncture: Performed once daily for 10 consecutive days, 20 minutes per session, using a frequency of 60 Hz. * Acupuncture Points: Jiaji (L3-S1), Dachangshu (BL25), Huantiao (GB30), Yinmen (BL37), Yanglingquan (GB34), Chengfu (BL36), Chengshan (BL57), and Kunlun (BL60). Intervention Name: \- Procedure: Electroacupuncture
Procedure: Electroacupuncture
Electroacupuncture is performed using sterile disposable acupuncture needles (0.30 × 25 mm) connected to an electroacupuncture stimulator (KWD808-1, Gujin Greatwall, China). Stimulation is applied at a frequency of 60 Hz for 20 minutes per session. Treatment is performed once daily for 10 consecutive days. Acupuncture points include Jiaji (L3-S1), Dachangshu (BL25), Huantiao (GB30), Yinmen (BL37), Yanglingquan (GB34), Chengfu (BL36), Chengshan (BL57), and Kunlun (BL60).
Intravascular laser irradiation of blood (ILIB) is administered using a helium-neon laser device (Mini-630, 635 nm wavelength) manufactured by the Vietnam Laser Technology Center. A sterile optical fiber is inserted into a peripheral vein via a standard intravenous needle. The laser is connected to the fiber to deliver continuous photobiomodulation for 30 minutes per session, 5 sessions per week, for 2 consecutive weeks (10 sessions total). This device is used only in the experimental group in combination with electroacupuncture.
Recruitment Velocity
The programmatic feasibility of patient acquisition calculated as the percentage of successfully randomized participants out of the total number of screened continuous adult outpatients presenting with persistent lumbar radiculopathy over the institutional trial window.
Time frame: From start of screening up to study primary completion (12 months).
Protocol Treatment Adherence
The operational adherence tracked as the percentage of successfully completed active intervention sessions out of the 10 scheduled combinations of electroacupuncture and intravascular photobiomodulation within the active treatment phase.
Time frame: Up to active treatment completion (Day 15).
Longitudinal Cohort Retention Rate
The percentage of randomized participants who remain fully evaluable and complete the final exploratory post-intervention follow-up matrix without dropping out.
Time frame: Up to the exploratory follow-up milestone (Day 22).
Change in Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality and disturbances over the previous month. It includes 19 items grouped into 7 components (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each component is scored from 0 to 3, and the global PSQI score ranges from 0 to 21, where higher scores indicate poorer sleep quality.
Time frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Post-treatment follow-up).
Change in Epworth Sleepiness Scale (ESS) Score
The Epworth Sleepiness Scale (ESS) measures daytime sleepiness across eight daily situations, rated from 0 (no chance of dozing) to 3 (high chance of dozing). The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Time frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
Change in Visual Analog Scale (VAS) for Pain
Pain intensity is measured using a 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 100 indicates "worst imaginable pain." Scores are categorized as follows: 0-1 (no pain), 1-4 (mild), 4-6 (moderate), \>6 (severe). The change in VAS from baseline to each follow-up point will be analyzed.
Time frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
Change in Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is a standardized questionnaire that measures the degree of disability related to low back pain. It consists of 10 sections, each scored from 0 to 5. The total score is expressed as a percentage from 0% to 100%, where 0% indicates no disability and 100% indicates maximum disability. Higher scores represent worse functional impairment.
Time frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
Cumulative Rescue Analgesic Requirements
Behavioral drug reliance derived from structured patient diaries, logged mathematically as cumulative weekly paracetamol intake to assess treatment dependence variations between the parallel arms.
Time frame: Week 1 (Days 1-7), Week 2 (Days 8-15), and Week 3 (Days 16-22; Post-treatment tracking).
Plan to share: Yes — Individual participant data (IPD) that will be shared include: demographic characteristics (age, sex, BMI, occupation) and de-identified outcome data related to pain, sleep quality, disability, and daytime sleepiness (VAS, PSQI, ODI, ESS). No identifiable personal information will be shared.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The de-identified individual participant data and supporting documents will be available upon publication of the main results and remain accessible for at least 3 years after study completion.
Access criteria: Qualified researchers may request access to the data by submitting a written proposal and analysis plan to the principal investigator (Dr. Le Hoang Minh Quan, University of Medicine and Pharmacy at Ho Chi Minh City). Data will be shared after approval of the research proposal and execution of a data-sharing agreement ensuring compliance with confidentiality and ethical standards.
Ran from Apr 2025 to primary completion in Dec 2025, 8 months.
Of 208 non-industry interventional studies with no phase under Sleep Wake Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 40. This study's 8 months is below that.
Counting every sponsor, half of 243 studies reached it within 19 months; a quarter within 6 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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