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Completed
NCT06755593
Intravascular Laser and Electroacupuncture for Sciatica With Insomnia: A Pilot Trial
Conditions: Sleep Disorders, Sciatica
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 66
Sponsor: Le Hoang Minh Quan
Location: Binh Dinh Traditional Medicine and Rehabilitation Hospital Qui Nhon Binh Dinh
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06755593). StuddyBuddy aggregates publicly available trial information.