insomnia/chronic low back pain
Conditions
Interventions
Observation group:acupuncture type 1
Control group:acupuncture type 2
Health control group:None
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years old; (2) meet the cLBP diagnosis criteria: pain, muscle tension or stiffness below the costal margin and above the subgluteal fold, lasting for at least 3 months; (3) Meet the diagnostic criteria for lumbar disc herniation, lumbar degenerative disease, lumbar muscle strain or non-specific low back pain; (4) Meet the DSM-5 diagnostic criteria for insomnia; (5) Not participating in other clinical research projects within the past 3 months; (6) Agree to participate in this research Healthy subjects: (1) Age =18 years old; (2) without accompanied by chronic pain; (3) without insomnia symptoms; (4) not accompanied by serious physical disease; (5) Be able to cooperate with relevant inspections.
Exclusion criteria
Exclusion criteria: (1) with severe heart, liver, kidney, nervous system disease or mental illness; (2) low back pain caused by tumor, spinal inflammation, lumbar deformity, lumbar spondylolisthesis, spinal fracture, trauma, skin disease, and retroperitoneal organ and pelvic organ lesions; (3) pregnant; (4) a taboo on acupuncture treatment; (5) failure to cooperate with researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index, ISI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric Rating Scale, NRS;Hamilton Depression Scale, HAMD;Hamilton Anxiety Scale, HAMA;HD-EEG;rs-fMRI;Adverse outcome; | — |
Countries
China
Contacts
Public ContactLi Zhihao
Shanghai Sixth People's Hospital
Outcome results
None listed