Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 1:05 AM
NCT ID:
NCT06755593
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.
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 April to December 2024.
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 electroacupuncture at 60 Hz for 20 minutes daily for 10 consecutive days, targeting Ashi points, Jiaji points (lumbar region), Dachangshu, Shangliao, and Ciliao.
* Intervention Group (n = 33): Received the same electroacupuncture regimen plus low-level intravascular laser irradiation (30 minutes per session, 5 sessions per week for 2 weeks).
Outcome measures included:
1. Visual Analog Scale (VAS): For pain intensity.
2. Oswestry Disability Index (ODI): For functional disability.
3. Pittsburgh Sleep Quality Index (PSQI): For sleep quality.
4. Epworth Sleepiness Scale (ESS): For daytime sleepiness. Assessments were performed at baseline (Day 0), Day 7, and Day 15 by trained physicians using standardized protocols. Data analysis employed mixed-effects linear regression models to evaluate treatment effects over time and between groups.
Ethical approval was obtained from the Ethics Committee of the Binh Dinh Hospital of Traditional Medicine and Rehabilitation and the Science and Technology Council of the Binh Dinh Department of Health (Approval Number: 445/QĐ-SYT).
This pilot study aims to provide preliminary clinical evidence on the efficacy and safety of intravascular photobiomodulation for pain and sleep management in chronic sciatica, serving as a foundation for larger-scale trials and contributing to the development of integrative, non-pharmacologic treatment strategies in rehabilitation medicine.
Study:
NCT06755593
Study Brief:
Protocol Section:
NCT06755593