Painful Diabetic Peripheral NeuropathyNCT06158529
High-frequency SCS Versus SCS in the Treatment of Diabetic Peripheral Neuropathic Pain
A study testing spinal cord stimulator and high frequency spinal cord stimulation in people with Painful Diabetic Peripheral Neuropathy, run by Fan BiFa at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy
- What is being tested?
- spinal cord stimulator and high frequency spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with diabetes, aged between 18 and 80 years old;
- Symmetrical pain in the distal lower extremities with or without dysesthesia;
- Duration of symptoms exceeding 6 months;
- Pain described as stabbing and/or electric shock-like and/or burning sensation;
- Abnormal Quantitative Sensory Testing (QST);
- Presence of hyperalgesia and allodynia;
- Absence of lower limb reflexes and muscle strength abnormalities;
- Normal MRI or CT scans without spinal canal stenosis or other spinal abnormalities.
Who cannot join
- Concurrent severe cardiovascular and cerebrovascular diseases;
- 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;
- Presence of radicular symptoms;
- Other spinal abnormalities, such as benign or malignant tumors, congenital abnormalities of the spine, spinal instability, etc.;
- Coexisting disorders of the coagulation system, malignant tumors, infections, and psychiatric or psychological disorders;
- Pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Peng Mao
About this study
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
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.
Read the 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.
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Being tested
- spinal cord stimulator, high frequency spinal cord stimulation
- Keywords
- spinal cord stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal cord stimulatorDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| spinal cord stimulation | Active comparator | Traditional spinal cord electrical stimulation Receives: Device: spinal cord stimulator |
| high frequency spinal cord stimulation | Experimental | High frequency SCS (HF-SCS) technology can treat chronic pain without relying on the tingling sensation Receives: Device: high frequency spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start6 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fan BiFa
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Xuanwu Hospital, Beijing, Civil Aviation General Hospital, Shenzhen Sixth People's Hospital, Beijing Tiantan Hospital
- Responsible party
- Sponsor-investigator, Fan BiFa, China-Japan Friendship Hospital
- Investigators
- BiFa Fan, master, Study chair, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158529
- Sponsor's protocol ID
- SF-2022-1-4061
- Status last verified
- Feb 2025
- First submitted
- 28 Nov 2023
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06158529
- Acronym / sponsor ID
- SF-2022-1-4061
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Keywords
- spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Fan BiFaUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Xuanwu Hospital, Beijing, Civil Aviation General Hospital, Shenzhen Sixth People's Hospital, Beijing Tiantan Hospital
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| spinal cord stimulation | Active comparator | Device: spinal cord stimulatorTraditional spinal cord electrical stimulation |
| high frequency spinal cord stimulation | Experimental | Device: high frequency spinal cord stimulationHigh frequency SCS (HF-SCS) technology can treat chronic pain without relying on the tingling sensation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with diabetes, aged between 18 and 80 years old;
- Symmetrical pain in the distal lower extremities with or without dysesthesia;
- Duration of symptoms exceeding 6 months;
- Pain described as stabbing and/or electric shock-like and/or burning sensation;
- Abnormal Quantitative Sensory Testing (QST);
Key exclusion criteria (6 listed)
- Concurrent severe cardiovascular and cerebrovascular diseases;
- 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;
- Presence of radicular symptoms;
- Other spinal abnormalities, such as benign or malignant tumors, congenital abnormalities of the spine, spinal instability, etc.;
- Coexisting disorders of the coagulation system, malignant tumors, infections, and psychiatric or psychological disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spinal cord stimulatorA spinal cord stimulator is an implanted device that sends low levels of electricity directly into the spinal cord to relieve pain. | Device | spinal cord stimulation |
| high frequency spinal cord stimulationA spinal cord stimulator is an implanted device that sends low levels and high frequency of electricity directly into the spinal cord to relieve pain. | Device | high frequency spinal cord stimulation |
Primary outcome
treatment effectiveness
Time frame: 3months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BiFa Fan, master study chair
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal cord stimulator and high frequency spinal cord stimulation in people with Painful Diabetic Peripheral Neuropathy, run by Fan BiFa at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BiFa Fan, master (18811358829 ext. 086, Lichen1616@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment effectiveness (time frame: 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.