Late stage Parkinson's disease patients with lower back pain and gait disorders
Conditions
Interventions
A group:Phase 1: 3-month 'active stimulation' mode ( true stimulation)
Washout period: 4 weeks
Phase 2: 3-month 'cross' stimulation pattern( false stimulation)
B group:Phase 1: 3-month 'active stimulation' mode ( false stimulation)
Washout period: 4 weeks
Phase 2: 3-month 'cross' stimulation pattern ( true stimulation) ( true stimulation)
Sponsors
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
50 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age range: 50-75 years old. 2. Idiopathic Parkinson's disease that meets the clinical diagnostic criteria of the International Association of Motor Disorders, with Hoehn & Yahr staging in the "open stage" as III-IV. 3. The disease course is >= 5 years, and there is chronic (>= 6 months) moderate to severe back pain that is difficult to control with medication (NRS >= 4 points). 4. There is a clear "off period" gait disorder, manifested as frozen gait and/or postural instability (using a frozen gait questionnaire score of >= 10, or having a history of >= 1 fall in the past 3 months). 5. The optimal drug treatment regimen (including dopaminergic drugs) is stable for at least one month, and symptom control is still not ideal. 6. Cognitive function can be evaluated and treated in conjunction with Montreal Cognitive Assessment (MoCA >= 18 points). 7. Sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Secondary Parkinson's syndrome or atypical Parkinson's disease (such as multiple system atrophy, progressive supranuclear palsy); 2. There are spinal structural lesions that require priority surgical treatment, such as nerve root pain or lumbar spinal stenosis; 3. SCS or surgical contraindications (such as coagulation dysfunction, immunosuppression, systemic or local infections, inability to cooperate with MRI examination); 4. Accompanied by other serious or unstable internal medicine or psychiatric disorders; 5. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lower back pain index score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory gait analysis;Stand up walking test;Quality of Life; | — |
Countries
China
Contacts
Public ContactHongyu Zhou
Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine
Outcome results
None listed