Chronic pain of the trunk and/or limbs
Conditions
Interventions
Experimental group:stimulation continued in the random period
Roll-in group:Stimulation continued in the random period
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Phase I Enrollment Criteria: 1. Participants aged 18 years or older. 2. Chronic intractable pain persisting for at least 3 months, refractory to conservative therapies (e.g., pharmacotherapy, physical therapy). 3. Baseline pain intensity >=5 on the Visual Analog Scale (VAS), documented in a 4-day pre-implantation diary. 4. Participants demonstrating good compliance and ability to complete postoperative follow-up. 5. Participants can understand the study procedures and sign the informed consent. Phase II Treatment Eligibility: Pain VAS scores during the test period show a =50% improvement compared to the baseline period.
Exclusion criteria
Exclusion criteria: 1. Spinal anatomical abnormalities prevented electrode implantation. 2. Pregnancy, breastfeeding, planned pregnancy, or refusal to use contraception. 3. Bleeding disorders or coagulation abnormalities. 4. Inability to cooperate during surgery or post-operative programming. 5. Life expectancy of less than one year. 6. Presence of implanted neurostimulators, cardiac pacemakers, or similar medical devices. 7. Participation in other clinical trials before reaching the primary endpoint. 8. Other conditions considered unsuitable by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference of maximal visual-analog scale (VAS) score between Experimental group and Conrol group in the withdrawal period compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in VAS Scores from Baseline;Response Rate (= 50% reduction VAS);Achievement Rate of a Desirable Pain State (VAS score <=3);Pittsburgh Sleep Quality Index (PSQI);Beck Depression Inventory (BDI);Health-Related Quality of Life Questionnaire (SF-36);The Use of Medications Related to Pain Management;Device Comfort Assessment (7-Point Likert Scale);Device Usability Evaluation (7-Point Likert Scale);Device Operability Assessment (7-Point Likert Scale);Surgical Success Rate;Surgical Duration;Intraoperative Blood Loss; | — |
Countries
China
Contacts
Public ContactFan Bifa
China-Japan Friendship Hospital
Outcome results
None listed