Intravascular Laser and Electroacupuncture for Sciatica With Insomnia: A Pilot Trial
Effectiveness of Intravenous Laser Therapy in Patients With Sciatica and Sleep Disorders at Binh Dinh Hospital of Traditional Medicine and Rehabilitation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Sciatica, characterized by radiating pain along the sciatic nerve, is one of the most common causes of chronic low back pain. The condition affects approximately 13%-40% of adults globally and remains a major contributor to disability, reduced productivity, and impaired quality of life. In Vietnam, hospital-based surveys have reported that sciatica accounts for 12%-26% of inpatient admissions in traditional medicine and rehabilitation facilities.
Chronic musculoskeletal pain such as sciatica is frequently associated with sleep disorders. Studies indicate that up to 70% of patients with chronic pain experience poor sleep quality, and the relationship between pain and sleep is bidirectional: persistent pain interferes with sleep continuity, while sleep deprivation increases pain sensitivity and emotional distress. Conventional pharmacologic treatments for insomnia (such as benzodiazepines or non-benzodiazepine hypnotics) often provide temporary relief but may cause tolerance, dependence, or adverse cognitive effects. Consequently, non-pharmacologic and integrative approaches are increasingly emphasized in chronic pain management.
Intravascular photobiomodulation (ILIB), also referred to as intravascular laser irradiation of blood, is a minimally invasive technique that introduces low-level laser light (typically 630-650 nm) into the venous circulation. The photobiological effects of ILIB include enhanced oxygen transport, improved microcirculation, modulation of oxidative stress, and anti-inflammatory action. Clinical studies have demonstrated ILIB's potential in various chronic diseases, including musculoskeletal pain, vascular disorders, and metabolic dysfunctions. Preliminary evidence also suggests that ILIB may enhance sleep quality through regulation of circadian and autonomic function.
This randomized controlled pilot study was designed to evaluate the short-term efficacy of ILIB combined with electroacupuncture in improving pain and sleep quality in patients with chronic sciatica. The trial was conducted at the Binh Dinh Hospital of Traditional Medicine and Rehabilitation, Vietnam, from January to December 2025.
A total of 66 patients aged 18 years or older, diagnosed with chronic sciatica (pain duration ≥ 3 months) and sleep disturbance (Pittsburgh Sleep Quality Index > 5), were recruited and randomly assigned to one of two groups:
- Control Group (n = 33): Received standardized electroacupuncture at a continuous frequency of 60 Hz for 20 minutes per session, once daily for 10 sessions over 2 weeks. Acupuncture points targeted specific dermatomal roots matching the sciatic path: Jiaji (L3-S1), Dachangshu (BL25), Huantiao (GB30), Yinmen (BL37), Yanglingquan (GB34), Chengfu (BL36), Chengshan (BL57), and Kunlun (BL60).
- Intervention Group (n = 33): Received the identical electroacupuncture regimen plus adjunctive low-level intravascular laser irradiation (wavelength: 630 nm; output power: 2.5 mW) administered continuously for 30 minutes per session, totaling 10 sessions.
To control for pharmacological confounding factors, participants were restricted from modifying baseline drug therapies or initiating non-protocol physical modalities. Permitted rescue analgesic medication was restricted to paracetamol (maximum 2 g/day), tracked quantitatively via daily patient compliance diaries. Outcome measures were logged across four temporal milestones: baseline (Day 0), Day 7, Day 15, and an exploratory post-treatment follow-up on Day 22 to examine short-term carry-over retention after treatment withdrawal. Longitudinal data analysis was performed using linear mixed-effects regression models to handle repeated measurements while protecting statistical transparency.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Binh Dinh
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Qui Nhon, Binh Dinh, Vietnam, 55100
- Binh Dinh Traditional Medicine and Rehabilitation Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Electroacupuncture and intravenous laser
Participants in this group receive combined electroacupuncture and intravascular laser irradiation of blood (ILIB).
Intervention Name:
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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).
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.
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Active Comparator: Electroacupuncture
Participants in this group receive electroacupuncture only.
Intervention Name: - 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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Recruitment Velocity
Time Frame: From start of screening up to study primary completion (12 months).
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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.
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From start of screening up to study primary completion (12 months).
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Protocol Treatment Adherence
Time Frame: Up to active treatment completion (Day 15).
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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.
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Up to active treatment completion (Day 15).
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Longitudinal Cohort Retention Rate
Time Frame: Up to the exploratory follow-up milestone (Day 22).
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The percentage of randomized participants who remain fully evaluable and complete the final exploratory post-intervention follow-up matrix without dropping out.
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Up to the exploratory follow-up milestone (Day 22).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time Frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Post-treatment follow-up).
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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.
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Days 0 (baseline), 7, 15, and Day 22 (Exploratory Post-treatment follow-up).
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Change in Epworth Sleepiness Scale (ESS) Score
Time Frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
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The Epworth Sleepiness Scale (ESS) measures daytime sleepiness across eight daily situations, rated from 0 (no chance of dozing) to 3 (high chance of dozing).
The total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
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Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
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Change in Visual Analog Scale (VAS) for Pain
Time Frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
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Pain intensity is measured using a 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 100 indicates "worst imaginable pain."
Scores are categorized as follows: 0-1 (no pain), 1-4 (mild), 4-6 (moderate), >6 (severe).
The change in VAS from baseline to each follow-up point will be analyzed.
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Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
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Change in Oswestry Disability Index (ODI)
Time Frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
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The Oswestry Disability Index (ODI) is a standardized questionnaire that measures the degree of disability related to low back pain.
It consists of 10 sections, each scored from 0 to 5. The total score is expressed as a percentage from 0% to 100%, where 0% indicates no disability and 100% indicates maximum disability.
Higher scores represent worse functional impairment.
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Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
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Cumulative Rescue Analgesic Requirements
Time Frame: Week 1 (Days 1-7), Week 2 (Days 8-15), and Week 3 (Days 16-22; Post-treatment tracking).
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Behavioral drug reliance derived from structured patient diaries, logged mathematically as cumulative weekly paracetamol intake to assess treatment dependence variations between the parallel arms.
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Week 1 (Days 1-7), Week 2 (Days 8-15), and Week 3 (Days 16-22; Post-treatment tracking).
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Neuralgia
- Mononeuropathies
- Sciatic Neuropathy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Sleep Wake Disorders
- Sciatica
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Anesthesia and Analgesia
- Electric Stimulation Therapy
- Combined Modality Therapy
- Anesthesia
- Analgesia
- Acupuncture Therapy
- Transcutaneous Electric Nerve Stimulation
- Electroacupuncture
Other Study ID Numbers
- 445/QĐ-SYT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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