Efficacy of Combined Intravascular Laser Irradiation and Electroacupuncture on the Pain-insomnia Cycle in Chronic Sciatica: A Pilot Randomized Trial

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

Interventions

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).

DEVICE

Intravascular Low-Level Laser Therapy (ILIB)

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.

Sponsors & Collaborators

• Binh Dinh Hospital of Traditional Medicine and Rehabilitation

  collaborator UNKNOWN

• Le Hoang Minh Quan

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-01

Primary Completion

2025-12-01

Completion

2025-12-01

Countries

• Vietnam

Study Locations