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

NCT06755593 | Completed

• 1 other identifier: 445/QĐ-SYT
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disorders; Sciatica

Keywords

sciatica; sleep disorders; intravenous laser; electroacupuncture

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

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

Secondary Outcomes (5)

• Change in Pittsburgh Sleep Quality Index (PSQI) Score

  Days 0 (baseline), 7, 15, and Day 22 (Exploratory Post-treatment follow-up).

• Change in Epworth Sleepiness Scale (ESS) Score

  Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).

• Change in Visual Analog Scale (VAS) for Pain

  Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).

• Change in Oswestry Disability Index (ODI)

  Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).

• Cumulative Rescue Analgesic Requirements

  Week 1 (Days 1-7), Week 2 (Days 8-15), and Week 3 (Days 16-22; Post-treatment tracking).

Study Arms (2)

Electroacupuncture and intravenous laser

EXPERIMENTAL

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)

Electroacupuncture

ACTIVE COMPARATOR

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

Interventions

Electroacupuncture PROCEDURE

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).

Electroacupuncture; Electroacupuncture and intravenous laser

Intravascular Low-Level Laser Therapy (ILIB) DEVICE

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.

Electroacupuncture and intravenous laser

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Le Hoang Minh Quan: lead
• Binh Dinh Hospital of Traditional Medicine and Rehabilitation: collaborator

Study Sites (1)

Binh Dinh Traditional Medicine and Rehabilitation Hospital

Qui Nhon, Binh Dinh, 55100, Vietnam

Location

Related Links

• N. E. Adler and K. Newman (2002), "Socioeconomic disparities in health: pathways and policies", Health Aff (Millwood). 21(2), pp. 60-76.
• Daniel J Buysse, et al (1989), "The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research", J Psychiatry research. 28(2), pp. 193-213.
• J. C. Fu, N. K. Wang, Y. Y. Cheng and S. T. Chang (2022), "The Adjuvant Therapy of Intravenous Laser Irradiation of Blood (ILIB) on Pain and Sleep Disturbance of Musculoskeletal Disorders", J Pers Med. 12(8).
• Y. L. Chang and S. T. Chang (2022), "The effects of intravascular photobiomodulation on sleep disturbance caused by Guillain-Barré syndrome after Astrazeneca vaccine inoculation: Case report and literature review", Medicine (Baltimore). 101(6), e28758
• S. Asih, et al. (2014), "Insomnia in a chronic musculoskeletal pain with disability population is independent of pain and depression", Spine J. 14(9), pp. 2000-7.
• Sirous Momenzadeh and et al (2015), "The intravenous laser blood irradiation in chronic pain and fibromyalgia", Journal of lasers in medical sciences. 6(1), pp. 6.

MeSH Terms

Conditions

Sleep Wake Disorders; Sciatica

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Pain

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Pilot Trial

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: April 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

VN (1)