CompletedNot Applicable

Intravascular Laser and Electroacupuncture for Sciatica With Insomnia: A Pilot Trial

Vietnam66 participantsStarted 2025-04-01

Plain-language summary

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.

Who can participate

Age range

18 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: * Adults aged ≥ 18 years. * Diagnosis of chronic sciatica pain lasting ≥ 3 months. * Sleep disturbance defined by a Pittsburgh Sleep Quality Index (PSQI) score \> 5. * Pain intensity score ≥ 50 mm on a 100-mm Visual Analog Scale (VAS). * Able to walk independently (with or without walking aids). * Provided written informed consent to participate in the study. Exclusion Criteria: * Malignant diseases, autoimmune diseases, or systemic inflammatory disorders. * History of prior spinal surgery. * Acute low back pain of \< 4 weeks' duration. * Primary sleep disorders (e.g., narcolepsy, sleep apnea, circadian rhythm disorders). * Diagnosed psychiatric conditions such as depression, anxiety, or delirium. * Current use of psychotropic, antidepressant, hypnotic, corticosteroid, or antihistamine medications. * Contraindications to low-level intravascular laser irradiation (e.g., hemophilia, acute myocardial infarction, acute stroke within 72 hours, active infection, pregnancy). * Signs or suspicion of severe spinal conditions (e.g., cancer, vertebral fracture, spinal infection, or cauda equina syndrome). * Concurrent involvement of lumbosacral nerve roots, plexus, or peripheral neuropathy confirmed by electrodiagnostic testing.

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

Recruitment Velocity

Timeframe: From start of screening up to study primary completion (12 months).

Protocol Treatment Adherence

Timeframe: Up to active treatment completion (Day 15).

Longitudinal Cohort Retention Rate

Timeframe: Up to the exploratory follow-up milestone (Day 22).

Trial details

NCT IDNCT06755593

SponsorLe Hoang Minh Quan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-01

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