Clinical trial NCT06755593: Effectiveness of Intravenous Laser Therapy on Patients with Sciatica and Sleep Disorders
Official title: Effectiveness of Intravenous Laser Therapy in Patients with Sciatica and Sleep Disorders At Binh Dinh Hospital of Traditional Medicine and Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sciatica, Sleep Disorders
Keywords: sciatica
sleep disorders
intravenous laser
electroacupuncture
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
Collaborators: name: Binh Dinh Hospital of Traditional Medicine and Rehabilitation
First posted: 2025-01-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized Controlled Trial
Primary purpose: TREATMENT

Brief summary: Sciatica is a common condition worldwide as well as in Vietnam, with prevalence rates from various studies ranging from 1.2% to 43%. The lifetime prevalence of this condition is estimated to be between 13% and 40%. According to the 2023 performance report from the Binh Dinh Traditional Medicine and Rehabilitation Hospital, sciatica accounted for the highest proportion of hospital admissions, at 26.37%. Notably, sleep disorders associated with chronic pain conditions such as sciatica are increasingly recognized as a significant concern. Therefore, pain management and sleep management are increasingly acknowledged as important for public health. Globally, numerous studies have demonstrated the efficacy and safety of laser therapy, both as a standalone treatment and in combination, for pain control and sleep disorder management. Hence, this study was conducted to evaluate the effectiveness of intravenous laser therapy in patients with sciatica accompanied by sleep disorders.

Detailed description: A randomized controlled intervention study. A total of 66 patients diagnosed with sciatica lasting over 3 months (pain-VAS ≥ 50) accompanied by sleep disorders with a PSQI score ≥ 11 were treated at Binh Dinh Traditional Medicine and Rehabilitation Hospital. Participants were divided into two groups.

* The control group (n=33) received electroacupuncture at the following points: Jiaji (L3-S1), Dachangshu (BL25), Huantiao (GB30), Yinmen (BL37), Yanglingquan (GB34), Chengfu (BL36), Chengshan (BL57), and Kunlun (BL60).
* The intervention group (n=33) received manual acupuncture at the same points: Jiaji (L3-S1), Dachangshu (BL25), Huantiao (GB30), Yinmen (BL37), Yanglingquan (GB34), Chengfu (BL36), Chengshan (BL57), and Kunlun (BL60), combined with intravenous Helium-Neon laser therapy using the BIO-ILIB He-Ne laser device (635 nm) for 30 minutes.

The treatment course lasted 15 days, with evaluation indices including VAS, ODI, and PSQI scores measured on days 7 and 15.

Eligibility criteria: Inclusion Criteria:

* Chronic sciatica pain lasting \> 3 months
* Sleep disorder with a PSQI score ≥ 11 points
* Pain score (Pain-VAS) ≥ 50 on a 100mm scale
* Ability to walk independently (with or without walking aids)
* Consent to participate in the study

Exclusion Criteria:

* History of prior spinal surgery
* 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, other nerves in the leg, or polyneuropathy confirmed by electrodiagnostic tests
* Presence of systemic inflammatory diseases, including rheumatoid arthritis, gout, ankylosing spondylitis, or psoriatic arthritis
* Unstable or untreated severe medical conditions (e.g., end-stage renal failure, severe liver failure, NYHA class IV heart failure)
* Alcohol abuse or substance addiction
* Damaged skin in acupuncture areas or history of hypersensitivity to acupuncture
* Pregnancy or breastfeeding
* History of hypersomnia (excessive daytime sleepiness), sleep disorders caused by breathing issues, circadian rhythm sleep-wake disorders (e.g., advanced or delayed sleep phase syndrome), or psychiatric conditions such as depression, generalized anxiety disorder, or delirium
* Current use of antidepressants, psychotropic drugs, sedatives (e.g., lithium, benzodiazepines), glucocorticoids, or antihistamines

Primary outcomes:
measure: VAS scores
timeFrame: Days 0, 7 and 15
measure: ODI scores
timeFrame: Days 0, 7 and 15
measure: PSQI scores
timeFrame: Days 0, 7 and 15
Secondary outcomes:
Other outcomes:
Locations:
city: Quy Nhon
country: Vietnam
facility: Binh Dinh Traditional Medicine and Rehabilitation Hospital
state: Binh Dinh
Study officials:
References: