Efficacy of Combined Intravascular Laser Irradiation and Electroacupuncture on the Pain-insomnia Cycle in Chronic Sciatica: A Pilot Randomized 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, including in Vietnam, with prevalence rates ranging from 1.2% to 43%. Chronic sciatica is often associated with sleep disturbances, which can worsen pain perception and reduce quality of life. According to the 2023 report from the Binh Dinh Hospital of Traditional Medicine and Rehabilitation, sciatica accounted for approximately 26% of hospital admissions for musculoskeletal disorders. Sleep disorders, particularly insomnia, are frequently reported among patients with chronic pain, forming a bidirectional relationship in which pain disrupts sleep, and poor sleep amplifies pain sensitivity. Current pharmacological treatments for insomnia often provide limited benefits and can lead to adverse effects with long-term use. Therefore, non-pharmacologic, integrative interventions have gained increasing interest. Intravascular laser irradiation of blood (ILIB), also known as intravascular photobiomodulation, is a minimally invasive therapy that delivers low-level laser light (630-650 nm) directly into the venous circulation. ILIB has been reported to improve microcirculation, reduce oxidative stress, and modulate inflammation. Preliminary studies have suggested potential benefits for pain relief, sleep improvement, and functional recovery. This randomized controlled pilot study aims to evaluate the effectiveness of intravascular laser therapy in improving sleep quality and pain among patients with chronic sciatica. Sixty-six participants will be randomly assigned to two groups:

• A control group receiving electroacupuncture, and
• An intervention group receiving intravascular laser therapy combined with electroacupuncture. Treatment will be administered for 10 consecutive days. Clinical outcomes will be assessed using the Pittsburgh Sleep Quality Index (PSQI), Visual Analog Scale (VAS) for pain, Oswestry Disability Index (ODI), and Epworth Sleepiness Scale (ESS) at baseline, Day 7, and Day 15. The study seeks to provide preliminary evidence supporting intravascular photobiomodulation as a safe, non-pharmacologic adjunct therapy for improving both pain and sleep quality in patients with chronic low back pain and sciatica.

Conditions

Sleep Disorders; Sciatica

Keywords

sciatica; sleep disorders; intravenous laser; electroacupuncture

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 0 (baseline), 7, and 15 after initiation of treatment

Secondary Outcomes (3)

• Change in Visual Analog Scale (VAS) for Pain

  Days 0, 7 and 15

• Change in Oswestry Disability Index (ODI)

  Days 0 (baseline), 7, and 15.

• Change in Epworth Sleepiness Scale (ESS) Score

  Days 0, 7, and 15

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A Randomized Controlled 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: April 23, 2026

Record last verified: 2025-11

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)