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The prospective, single-arm, single-center clinical study of spinal cord stimulation therapy in treatment of intractable lower extremity pain

The prospective, single-arm, single-center clinical study of spinal cord stimulation therapy in treatment of intractable lower extremity pain

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039059
Enrollment
Unknown
Registered
2020-10-15
Start date
2020-10-19
Completion date
Unknown
Last updated
2021-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intractable lower extremity pain

Interventions

SCS group:Spinal cord stimulation

Sponsors

Shandong Provinvial Hospital affiliated to Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years, male or female; 2. Lower extremity pain lasted for more than 3 months, VAS >= 4 points, and regular conservative treatment for at least 1 month is invalid; 3. Patients who can be able to follow the therapy and the follow-up plan; 4. Patients who can objectively describe the symptoms, can take the initiative to cooperate, without any mental illness; 5. Subjects can understand and voluntarily endorse informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, brain, liver and body diseases who cannot tolerate minimally invasive surgery; 2. Patients with puncture site infection, coagulation dysfunction, etc.; 3. Patients who cannot tolerate the operation of epidural catheter/electrode; 4. Electrode cannot be implanted due to severe spinal anatomy abnormal; 5. Pregnancy or lactation; 6. With back or upper limb pain, resting pain is greater than 3 points at the same time.

Design outcomes

Secondary

MeasureTime frame
Short-form McGill Pain Questionnaire-2;Hospital Anxiety and Depression Scale;36-item Short-Form;Pittsburgh Sleep Quality Index;Analgesic dose;

Primary

MeasureTime frame
visual analogue scale;

Countries

China

Contacts

Public ContactSun Tao

Shandong Provinvial Hospital affiliated to Shandong First Medical University

suntaosdph@163.com+86 15168886872

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026