Clinical trial NCT06158529: High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain
Official title: A Multicentre Clinical Study of High-frequency Electrical Spinal Cord Stimulation Versus Electrical Spinal Cord Stimulation in the Treatment of Diabetic Peripheral Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Painful Diabetic Peripheral Neuropathy
Keywords: spinal cord stimulation
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Xuanwu Hospital, Beijing
name: Civil Aviation General Hospital
name: Shenzhen Sixth People's Hospital
name: Beijing Tiantan Hospital
First posted: 2023-12-06
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The incidence rate of diabetes peripheral neuropathic pain (DPNP) is high, and there is no clear and effective treatment, which is a clinical problem to be solved urgently.

Traditional spinal cord electrical stimulation (SCS) has the potential to treat DPNP, and its efficacy depends on the tingling sensation generated by the electrical stimulation covering the painful area of the patient. The neurological dysfunction of DPNP patients and the defects of traditional SCS lead to unsatisfactory therapeutic effects.

The emerging high-frequency SCS (HF-SCS) technology can treat chronic pain without relying on tingling sensation. Multiple evidence shows that HF-SCS has better long-term efficacy in treating chronic neuropathic pain than traditional SCS.

Our research group has also preliminarily confirmed the effectiveness and safety of HF-SCS in treating DPNP.

Therefore, this study intends to use a multicenter prospective randomized controlled clinical research method to explore the superiority of HF-SCS in treating DPNP compared to traditional SCS, and establish a standardized diagnosis and treatment platform database for DPNP in Beijing.

This project will provide high-level evidence-based medicine for the treatment of DPNP with HF-SCS, and also provide clinical big data support for the standardized diagnosis and treatment of DPNP in the future.

On the basis of medical engineering integration, an innovative remote control system is applied to achieve real-time adjustment and precise regulation of SCS treatment parameters.

Eligibility 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 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.

Primary outcomes:
measure: treatment effectiveness
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
affiliation: China-Japan Friendship Hospital
name: BiFa Fan, master
role: STUDY_CHAIR
References: