Failed Back Surgery Syndrome
Conditions
Interventions
Experimental Group:Peripheral stimulation uses a CCY-IA magnetic stimulator with figure-of-eight coil positioned 2 cm lateral to the L4-L5 spinous process at 90% motor threshold triggered every 5 seco
central stimulation employs neuronavigation to target the contralateral M1 multifidus representation area using a CCY-II magnetic stimulator at 110% resting motor threshold precisely triggered 25 mill
Control Group:Peripheral sham uses vertically oriented coil with zero output intensity paired with vibration pad simulating tactile sensation, central sham targets the M1 hand knob area distant from m
Sponsors
Shanghai Guanghua Hospital of Integrative Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years. 2. History of lumbar spine surgery including discectomy, laminectomy, or spinal fusion, with a minimum of 6 months post-surgery. 3. Persistent or recurrent low back pain or leg pain lasting =6 months, with a baseline Visual Analogue Scale (VAS) pain score =4. 4. Baseline functional impairment with Oswestry Disability Index score =30%. 5. Participants must not have any implanted metallic stents, pacemakers, or other devices contraindicated for magnetic stimulation, excluding spinal internal fixation devices. 6. Participants must provide written informed consent prior to enrollment in the trial.
Exclusion criteria
Exclusion criteria: 1. CT or MRI scans reveal clear indications for reoperation, such as severe nerve compression, progression of spinal canal stenosis, or failure of internal fixation. 2. Imaging demonstrates spinal structural abnormalities caused by tumors, tuberculosis, acute infections, fractures, or other pathological conditions. 3. Severe neurological deficits, including lower limb muscle strength = grade 3 or urinary/bowel dysfunction. 4. Received invasive neuromodulation therapy within the past 3 months, such as spinal cord stimulation or epidural injections. 5. Undergone other treatments affecting cortical excitability within the past 3 months, such as transcranial direct current stimulation (tDCS) or repetitive transcranial magnetic stimulation (rTMS). 6. Presence of TMS contraindications, including history of epilepsy, intracranial metal implants, or pregnancy/lactation. 7. Concurrent severe cardiovascular disease, psychiatric disorders, or cognitive impairment preventing participation in study assessments. 8. Current enrollment in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oswestry Disability Index;Surface Electromyography; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual analogue scale score;6-Minute Walk Test;Multifidus Muscle Ultrasound;EQ-5D Health Survey Short Form;motor evoked potentials; | — |
Countries
China
Contacts
Public ContactLu Hongyuan
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed