chronic, intractable pain
Conditions
Interventions
Experimental group:stimulation continued in the random period
Sponsors
The First Affiliated Hospital of Medical School of Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Testing period: (1) Aged >= 18 years, no gender limit; (2) Chronic intractable pain that lasts at least 3 months and refractory to the conservative therapies; (3) VAS assessment of pain degree score>=5; (4) Able to understand the purpose of the protocol, voluntarily participate and sign the informed consent. 2. Long-term implantation period: Pain VAS scores in the test period improved by more than 50% compared with baseline period.
Exclusion criteria
Exclusion criteria: 1. Testing period: (1) Severe mental or cognitive disorders, cannot cooperate during surgery and post-operative programming; (2) Severe cardiopulmonary insufficiency, coagulopathy or puncture site infection; (3) Subjects with drug abuse; (4) Spinal anatomic abnormalities prevented the electrodes from being implanted; (5) Subjects who are pregnant or breastfeeding; (6) Subjects who are participating in other clinical trials, not yet out of the group; (7) Other inappropriate situations determined by investigators. 2. Long-term implantation period: (1) Subjects who cannot tolerate SCS; (2) Other inappropriate situations determined by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in pain visual analogue scale (VAS) score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in VAS scores from baseline;Response rate was reduced by >=50% from baseline VAS score;Improvement rate of VAS score (VAS score <=4);Beck depression inventory for depression evaluation;Brief pain inventory (BPI);The European five-dimensional health scale (EQ - 5 D - 5 L);Short form McGill pain questionnare-2 (SF-MPQ-2);Pittsburgh sleep quality index (PSQI);Drug usage;Investigator's evaluation of operational performance of investigational equipment; | — |
Countries
China
Contacts
Public ContactFeng Zhiying
The First Affiliated Hospital of Medical School of Zhejiang University
Outcome results
None listed