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A Multicentre Clinical Study of High-frequency Electrical Spinal Cord Stimulation Versus Electrical Spinal Cord Stimulation in the Treatment of Diabetic Peripheral Neuropathic Pain

A Multicentre Clinical Study of High-frequency Electrical Spinal Cord Stimulation Versus Electrical Spinal Cord Stimulation in the Treatment of Diabetic Peripheral Neuropathic Pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078291
Enrollment
Unknown
Registered
2023-12-04
Start date
2024-01-04
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Diabetic Peripheral Neuropathic Pain

Interventions

HF-SCS:High frequency spinal cord stimulation
SCS:low frequency spinal cord stimulation

Sponsors

Beijing Municipal Health Commission
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with diabetes, aged between 18 and 80 years old; 2. Symmetrical pain in the distal lower extremities with or without dysesthesia; 3. Duration of symptoms exceeding 6 months; 4. Pain described as stabbing and/or electric shock-like and/or burning sensation; 5. Abnormal Quantitative Sensory Testing (QST); 6. Presence of hyperalgesia and allodynia; 7. Absence of lower limb reflexes and muscle strength abnormalities; 8. Normal MRI or C

Exclusion criteria

Exclusion criteria: 1. Concurrent severe cardiovascular and cerebrovascular diseases; 2. History of lumbar spine surgery, trauma, or spinal canal stenosis within the past 6 months, or a history of lumbar spine surgery, trauma, or spinal canal stenosis that would impact the SCS surgery and pain assessment in this study; 3. Presence of radicular symptoms; 4. Other spinal abnormalities, such as benign or malignant tumors, congenital abnormalities of the spine, spinal instability, etc.; 5. Coexisting disorders of the coagulation system, malignant tumors, infections, and psychiatric or psychological disorders; 6. Pregnancy.

Design outcomes

Primary

MeasureTime frame
numeric rating scale,NRS;

Secondary

MeasureTime frame
short form 12, SF-12;Athens Insomnia Scales, AIS;Beck Depression Inventory;Michigan Neuropathy Screening Instrument, MNSI;

Countries

China

Contacts

Public ContactFan BiFa

China-Japan Friendship Hospital

fbf1616@yeah.net+86 150 1010 1616

Outcome results

None listed

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