Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06158529
Other study ID # SF-2022-1-4061
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 27, 2023
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source China-Japan Friendship Hospital
Contact BiFa Fan, master
Phone 18811358829
Email Lichen1616@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Application of High-Frequency Spinal Cord Stimulation (HF-SCS) in the Treatment of Painful Diabetic Peripheral Neuropathy (PDPN): A multicenter, randomized controlled study comparing its clinical efficacy with traditional spinal cord stimulation for PDPN. The study aims to observe the impact of HF-SCS on the neurological function and microcirculation of PDPN patients, elucidating the correlation between the underlying diabetes and the efficacy of HF-SCS therapy on PDPN. The goal is to enhance the treatment standards for PDPN, improve the quality of life for this population, and overall treatment outcomes. Simultaneously, the study aims to contribute evidence-based medicine for the mechanistic exploration of PDPN.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1
Est. completion date December 31, 2025
Est. primary completion date November 28, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 CT scans without spinal canal stenosis or other spinal abnormalities. 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.

Study Design


Related Conditions & MeSH terms

  • Neuralgia
  • Painful Diabetic Peripheral Neuropathy
  • Peripheral Nervous System Diseases

Intervention

Device:
spinal cord stimulator
A spinal cord stimulator is an implanted device that sends low levels of electricity directly into the spinal cord to relieve pain.
high frequency spinal cord stimulation
A spinal cord stimulator is an implanted device that sends low levels and high frequency of electricity directly into the spinal cord to relieve pain.

Locations

Country Name City State
n/a

Sponsors (6)

Lead Sponsor Collaborator
Fan BiFa Beijing Tian Tan Hospital, Civil Aviation General Hospital, Peking University Third Hospital, Shenzhen Nanshan Hospital, Xuanwu Hospital, Beijing

Outcome

Type Measure Description Time frame Safety issue
Primary treatment effectiveness The treatment effectiveness is assessed based on the reduction of Numeric Rating Scale (NRS) scores for pain three months after treatment compared to before treatment. Specifically, a decrease of =50% in the pain NRS score [(NRS score at 3 months post-treatment - NRS score before treatment) / NRS score before treatment] = 50% is considered the criterion for treatment effectiveness 3months
See also
  Status Clinical Trial Phase
Completed NCT01726413 - A Clinical Trial to Study the Effects GRC 17536 in Patients With Painful Diabetic Peripheral Neuropathy (Painful Extremities Due to Peripheral Nerve Damage in Diabetic Patients). Phase 2
Completed NCT05123196 - Exploratory Study of MT-8554 in Subjects With Painful Diabetic Peripheral Neuropathy Phase 2
Terminated NCT04246619 - Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life Phase 4
Recruiting NCT03520608 - Painful Diabetic Peripheral Neuropathy Study of Chinese OutPatiEnt
Completed NCT03172598 - Study to Assess the Efficacy, Safety and Tolerability of MT- 8554 in Subjects With Painful Diabetic Peripheral Neuropathy Phase 2
Terminated NCT01280747 - Examination of Pregabalin Access for Treatment of Indicated Pain Disorders: the ExPAND Study
Completed NCT03176472 - Ricolinostat in Patients With Painful Diabetic Peripheral Neuropathy Phase 2
Completed NCT01455415 - Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain Phase 3