chronic low back pain
Conditions
Interventions
sham stimulation group:sham rTMS combined with exercise
intervention group1:high-frequency (HF) rTMS of the left primary motor cortex (M1) combined with exercise
intervetion group2:high-frequency (HF) rTMS of the left dorsolateral prefrontal cortex (DLPFC) combined with exercise
healthy control group:no intervention
Sponsors
Third Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria for patients with chronic low back pain (CLBP) are as follows: 1) a clinical diagnosis of CLBP with persistent pain = 3 months or intermittent pain >6 months; 2) aged 18-65 years; 3) score of at least 3 on the Visual Analogue Scale (VAS) in the preceding week; 4) right-hand dominance; 5) score of at least 26 on the Montreal Cognitive Assessment (MoCA), literacy or no difficulties in communication; 6) no pain treatment within the past 3 months; and 7) no contraindication for MRI (e.g., claustrophobia, pacemaker, or metal implants in the body) . The inclusion criteria for healthy controls these participants are as follows: 1) no symptoms of back pain for the past 6 months; 2) aged 18-65 years; 3) right-hand dominance;4) no symptoms of low back pain or other pain disorders such as migraine and fibromyalgia.
Exclusion criteria
Exclusion criteria: The exclusion criteria were as follows: 1) low back pain with specific causes (e.g., vertebral fracture, or severe osteoporosis); 2) any psychiatric disorders that require current pharmacotherapy; 3) a history of spine/hip/lower limb joint surgery or injury, or any plan of surgery in the next year. 4) menstrual pain, postpartum low back pain, pregnancy or any plan of pregnancy; 5) neurological diseases (e.g., traumatic brain injury or epilepsy), cardiocerebrovascular disease, hypertension with blood pressure higher than 160/100 mmHg; 6) presence of cancer, significant unexplained weight loss, any sign of intracranial lesions during MRI scans; 7) endocrine disorders, drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS ;P40 pressure pain threshold;central sensitization inventory ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment;Digit Span Test;Stroop test;Color Trails Test;Pittsburgh Sleep Quality Index;Insomnia Severity Index;Hamilton Depression Scale;Hamilton Anxiety Sca;Pain Catastrophizing Scale;Oswestry Disability Inde;Short-Form McGill Pain Questionnaire ;Tampa Scale of Kinesiophobia;Fear-avoidance belief questionnaire;Beck Depression Inventory;side effects; | — |
Countries
China
Contacts
Public ContactXiquan Hu
The Third Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed