Lumbar Disc Herniation with Chronic Sciatica-Related Insomnia Group
Conditions
Interventions
Lumbar Disc Herniation with Chronic Sciatica-Related Insomnia Group:None
Lumbar Disc Herniation with Chronic Sciatica without Insomnia Group:None
Healthy Control Group:None
Sponsors
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Lumbar Disc Herniation with Chronic Sciatica-related Insomnia Group 1.1 Age =18 years and =75 years, gender. 1.2 Right-handed. 1.3 Meets the diagnostic criteria for lumbar disc herniation with unilateral sciatica, disease duration =3 months, and moderate to severe pain intensity in the past 24 hours for radiating leg pain (below the knee), with an NRS score =4 points. 1.4 Meets the diagnostic criteria for chronic insomnia, with a PSQI total score >7 points, and the onset or exacerbation of insomnia is temporally related to the onset or worsening of sciatica. 1.5 Voluntarily participates and signs the informed consent form. 2. Lumbar Disc Herniation with Chronic Sciatica without Insomnia Group 2.1 Age =18 years and =75 years, gender. 2.2 Right-handed. 2.3 Meets the diagnostic criteria for lumbar disc herniation with unilateral sciatica, disease duration =3 months, and moderate to severe pain intensity in the past 24 hours for radiating leg pain (below the knee), with an NRS score =4 points. 2.4 Does not meet the diagnostic criteria for chronic insomnia, with a PSQI total score =7 points. 2.5 Voluntarily participates and signs the informed consent form. 3. Healthy Control Group 3.1 Age =18 years and =75 years, gender. 3.2 Right-handed. 3.3 No acute pain or injury, and no history of chronic pain in the past 12 months. 3.4 No clinically diagnosed sleep disorders, with a PSQI total score =7 points. 3.5 Voluntarily participates and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1. General Exclusion Criteria (Applicable to All Three Groups) 1.1 Suffering from severe or unstable cardiovascular, hepatic, renal, respiratory system, or hematopoietic system diseases, or chronic diseases that may significantly affect metabolism (e.g., uncontrolled diabetes, thyroid dysfunction). 1.2 Suffering from severe mental or neurological diseases, such as schizophrenia, epilepsy, dementia, Parkinson's disease, multiple sclerosis, etc. 1.3 Currently experiencing clinically significant depression or anxiety (Patient Health Questionnaire-9 (PHQ-9) score =10, and/or Generalized Anxiety Disorder-7 (GAD-7) score =10). 1.4 Being in the acute infection phase or having active systemic diseases at the time of group entry assessment. 1.5 Having regularly used (=3 days per week) medications that may significantly affect the central nervous system or metabolism within 4 weeks prior to group entry (including but not limited to opioid analgesics, sedative-hypnotics, antidepressants, etc.), and the duration of drug discontinuation from the last dose to the group entry assessment is less than 2 weeks; for long-acting formulations, if a longer washout period is required based on the drug's half-life, but the discontinuation period is insufficient; or, although unable to discontinue due to medical reasons, the ongoing use is judged by the principal investigator to be likely to significantly interfere with the study's primary outcomes. 1.6 Having worked night shifts (main work hours between 10 PM and 6 AM) on average =2 times per week, or having extremely irregular sleep-wake patterns, within 4 weeks prior to group entry. 1.7 Being in the pregnancy or lactation period. 1.8 Having a history of alcohol abuse or drug dependence. 1.9 Having severe visual or auditory impairments, or cognitive comprehension difficulties, making it impossible to cooperate with study assessments. 1.10 Having contraindications affecting EEG recording (e.g., severe scalp infections, skull defects) or venous blood collection (e.g., history of fainting at the sight of blood, infection at the blood collection site). 1.11 The investigator judges that any other circumstances may affect the reliability of the study results or the safety of participants. 2.Additional exclusion criteria for the lumbar disc herniation with chronic sciatica-related insomnia group and the lumbar disc herniation with chronic sciatica without insomnia group. 2.1 Suffering from lumbar spinal stenosis, lumbar spondylolisthesis, vertebral fractures, spinal tuberculosis, or tumors, or acute infectious diseases. 2.2 Suffering from cauda equina syndrome, conus medullaris syndrome, or having other absolute indications for surgery. 2.3 Suffering from other primary sleep disorders (e.g., sleep apnea syndrome, narcolepsy, restless legs syndrome). 3. Additional Exclusion Criteria for the Healthy Control Group 3.1 Having a history of spinal, joint, or neurological diseases that may cause chronic pain. 3.2 Having a history of any type of sleep disorder or clinical symptoms thereof.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microstate Parameter; | — |
Secondary
| Measure | Time frame |
|---|---|
| The relative abundance of differential metabolites in plasma.;Leg Pain Numerical Rating Scale (0–10 points);Pittsburgh Sleep Quality Index (PSQI);Low Back Pain Numerical Rating Scale (0–10 points);Oswestry Disability Index (ODI);Insomnia Severity Index (ISI);Patient Health Questionnaire-9 Items;Generalized Anxiety Disorder 7-Item Scale; | — |
Countries
China
Contacts
Public ContactWang Ke
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Outcome results
None listed