Sleep DisordersNCT06755593
Intravascular Laser and Electroacupuncture for Sciatica With Insomnia: A Pilot Trial
A study testing Electroacupuncture and Intravascular Low-Level Laser Therapy (ILIB) in people with Sleep Disorders and Sciatica, run by Le Hoang Minh Quan at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorders, Sciatica
- What is being tested?
- Electroacupuncture and Intravascular Low-Level Laser Therapy (ILIB)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Apr 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Binh Dinh Traditional Medicine and Rehabilitation Hospital
Qui Nhon, Binh Dinh, 55100
About this study
Official title: 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.
Read the 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.
- Conditions
- Sleep Disorders, Sciatica
- Being tested
- Electroacupuncture, Intravascular Low-Level Laser Therapy (ILIB)
- Keywords
- sciatica, sleep disorders, intravenous laser, electroacupuncture
- Medical subject headings
- Sleep Wake Disorders, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Procedure: Electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to the exploratory follow-up milestone (Day 22).
Secondary outcomes (5)
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.
Measured: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Post-treatment follow-up).
Change in Epworth Sleepiness Scale (ESS) Score
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.
Measured: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
Change in Visual Analog Scale (VAS) for Pain
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.
Measured: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
Change in Oswestry Disability Index (ODI)
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.
Measured: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
Cumulative Rescue Analgesic Requirements
Behavioral drug reliance derived from structured patient diaries, logged mathematically as cumulative weekly paracetamol intake to assess treatment dependence variations between the parallel arms.
Measured: Week 1 (Days 1-7), Week 2 (Days 8-15), and Week 3 (Days 16-22; Post-treatment tracking).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start1 Apr 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Pilot Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Le Hoang Minh Quan
- Sponsor type
- University, hospital or other
- Collaborators
- Binh Dinh Hospital of Traditional Medicine and Rehabilitation
- Responsible party
- Sponsor-investigator, Le Hoang Minh Quan, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755593
- Sponsor's protocol ID
- 445/QĐ-SYT
- Status last verified
- Jun 2026
- First submitted
- 24 Dec 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that will be shared include: demographic characteristics (age, sex, BMI, occupation) and de-identified outcome data related to pain, sleep quality, disability, and daytime sleepiness (VAS, PSQI, ODI, ESS). No identifiable personal information will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Intravenous Laser Therapy in Patients With Sciatica and Sleep Disorders at Binh Dinh Hospital of Traditional Medicine and Rehabilitation
- ClinicalTrials.gov ID
- NCT06755593
- Acronym / sponsor ID
- 445/QĐ-SYT
- Conditions
- Sleep Disorders, Sciatica
- Keywords
- sciatica, sleep disorders, intravenous laser, electroacupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Le Hoang Minh QuanUniversity, hospital or other
- Collaborators
- Binh Dinh Hospital of Traditional Medicine and Rehabilitation
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A Pilot Trial
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture and intravenous laser | Experimental | Procedure: Electroacupuncture, Device: Intravascular Low-Level Laser Therapy (ILIB)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) |
| Electroacupuncture | Active comparator | Procedure: ElectroacupunctureParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureElectroacupuncture 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). | Procedure or surgery | Electroacupuncture, Electroacupuncture and intravenous laser |
| 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. | Device | Electroacupuncture and intravenous laser |
Primary outcome
Recruitment Velocity
Time frame: From start of screening up to study primary completion (12 months).
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.
Protocol Treatment Adherence
Time frame: Up to active treatment completion (Day 15).
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.
Longitudinal Cohort Retention Rate
Time frame: Up to the exploratory follow-up milestone (Day 22).
The percentage of randomized participants who remain fully evaluable and complete the final exploratory post-intervention follow-up matrix without dropping out.
5 secondary outcomes
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Post-treatment follow-up).
Change in Epworth Sleepiness Scale (ESS) Score
Time frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
Change in Visual Analog Scale (VAS) for Pain
Time frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
Change in Oswestry Disability Index (ODI)
Time frame: Days 0 (baseline), 7, 15, and Day 22 (Exploratory Follow-up).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- N. E. Adler and K. Newman (2002), "Socioeconomic disparities in health: pathways and policies", Health Aff (Millwood). 21(2), pp. 60-76.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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).Link provided by the sponsor.
- 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), e28758Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that will be shared include: demographic characteristics (age, sex, BMI, occupation) and de-identified outcome data related to pain, sleep quality, disability, and daytime sleepiness (VAS, PSQI, ODI, ESS). No identifiable personal information will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and Intravascular Low-Level Laser Therapy (ILIB) in people with Sleep Disorders and Sciatica, run by Le Hoang Minh Quan at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Velocity (time frame: From start of screening up to study primary completion (12 months).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.