Complications; Prosthesis, Nervous System, Peripheral, PainNCT05827848
Evaluate the Safety and Efficacy of a Peripheral Nerve Stimulation
A study testing Percutaneous peripheral nerve stimulation system in people with Complications; Prosthesis, Nervous System, Peripheral, Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This trial was conducted in a prospective, multicenter, randomized withdrawal design at a designated clinical trial facility. The total sample size for this trial is expected to be 59-62 patients. One to two subjects were conducted in each study center as a preliminary test. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications; Prosthesis, Nervous System, Peripheral, Pain
- What is being tested?
- Percutaneous peripheral nerve stimulation system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2022to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, gender unlimited;
- The investigator judged that there was definite peripheral neuropathic pain (chronic and refractory pain in the trunk and extremities, including chronic pain after sternal surgery; Postherpetic neuralgia), suitable for percutaneous peripheral nerve stimulation system treatment;
- Preoperative assessment by neuropathic Pain Scale (DN4) showed that there were related damages or diseases in the peripheral sensory system;
- Patients with poor efficacy or can not tolerate the side effects of treatment after routine treatment;
- Visual analogue scale (VAS)≥50mm within 24 hours before treatment;
- The subject can understand the study purpose, demonstrate sufficient compliance with the study protocol, and be able and willing to sign the informed consent.
Who cannot join
- Patients who need to be treated with radiofrequency regulation and intrathecal drug infusion;
- Patients who are known to have had heart implants (pacemakers or defibrillators) or other implanted neurostimulators (spinal cord stimulators or deep brain stimulators, etc.);
- Patients with severe psychological and/or psychiatric illness and/or non-therapeutic drug dependence;
- Patients who are expected to undergo MRI within 30 days after PNS implantation;
- Expected to be discharged within 48 hours or less;
- There is known damage to the target nerve or muscle defect in the pain area;
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- Patients with known allergies to skin-to-skin contact materials (tape or adhesive);
- Known allergy to anesthetics such as lidocaine;
- Preoperative complications of severe heart, liver, kidney, respiratory diseases and coagulopathy;
- Pregnant or lactating women, or have a birth plan in the next 3 months;
- Is participating in any other drug or medical device clinical trial, or may participate in any other drug or medical device clinical trial after enrollment in this clinical trial;
- The investigator determined that there were other conditions that were not suitable to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ke Ma, PhD
Shanghai, Shanghai Municipality, 200000
Ke Ma, PhD, 86-21-25078707, marke72@163.com
About this study
Official title: A Prospective, Multicenter, Randomized Withdrawal Trial to Evaluate the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System in Patients With Peripheral Neuropathic Pain
This trial was conducted in a prospective, multicenter, randomized withdrawal design at a designated clinical trial facility. The total sample size for this trial is expected to be 59-62 patients.
One to two subjects were conducted in each study center as a preliminary test. A total of about 3-6 subjects were selected for the pre-test. The pre-test subjects used the test equipment (on state) and were not randomized.
Read more
The study was divided into screening/baseline period, treatment period (including test period, random withdrawal period and observation period) and follow-up period.
All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent Peripheral Nerve Stimulation(PNS) surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.
- Being tested
- Percutaneous peripheral nerve stimulation system
- Keywords
- Peripheral nerve pain
- Medical subject headings
- Neurologic Manifestations, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous peripheral nerve stimulation systemDevice
All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent PNS surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Turn on the machine for continuous nerve stimulation Receives: Device: Percutaneous peripheral nerve stimulation system |
| control group | No intervention | Turn off the machine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the mean VAS scores of the experimental group and the control group during the random withdrawal period
(VASEGbase -- VASEGwd) Average - (VASCGbase -- VASCGwd) Average
Explanation:
VASEGbase was the mean VAS score of subjects in the experimental group at 4 days before the random withdrawal period.
VASEGwd was the maximum VAS score of subjects in the experimental group during the random withdrawal period.
VASCGbase was the mean VAS score of subjects in the control group at 4 days before the random withdrawal period.
The maximum VAS score of subjects in the VASCGwd control group during the random withdrawal period.
Measured: 7 days after the wire implantation test period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start28 Oct 2022
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; Prosthesis, Nervous System, Peripheral, PainStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827848
- Sponsor's protocol ID
- XH-22-007
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Withdrawal Trial to Evaluate the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System in Patients With Peripheral Neuropathic Pain
- ClinicalTrials.gov ID
- NCT05827848
- Acronym / sponsor ID
- XH-22-007
- Keywords
- Peripheral nerve pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 Apr 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.
This trial was conducted in a prospective, multicenter, randomized withdrawal design at a designated clinical trial facility. The total sample size for this trial is expected to be 59-62 patients.
One to two subjects were conducted in each study center as a preliminary test. A total of about 3-6 subjects were selected for the pre-test. The pre-test subjects used the test equipment (on state) and were not randomized.
The study was divided into screening/baseline period, treatment period (including test period, random withdrawal period and observation period) and follow-up period.
All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent Peripheral Nerve Stimulation(PNS) surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Percutaneous peripheral nerve stimulation systemTurn on the machine for continuous nerve stimulation |
| control group | No intervention | –Turn off the machine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old, gender unlimited;
- The investigator judged that there was definite peripheral neuropathic pain (chronic and refractory pain in the trunk and extremities, including chronic pain after sternal surgery; Postherpetic neuralgia), suitable for percutaneous peripheral nerve stimulation system treatment;
- Preoperative assessment by neuropathic Pain Scale (DN4) showed that there were related damages or diseases in the peripheral sensory system;
- Patients with poor efficacy or can not tolerate the side effects of treatment after routine treatment;
- Visual analogue scale (VAS)≥50mm within 24 hours before treatment;
Key exclusion criteria (12 listed)
- Patients who need to be treated with radiofrequency regulation and intrathecal drug infusion;
- Patients who are known to have had heart implants (pacemakers or defibrillators) or other implanted neurostimulators (spinal cord stimulators or deep brain stimulators, etc.);
- Patients with severe psychological and/or psychiatric illness and/or non-therapeutic drug dependence;
- Patients who are expected to undergo MRI within 30 days after PNS implantation;
- Expected to be discharged within 48 hours or less;
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 |
|---|---|---|
| Percutaneous peripheral nerve stimulation systemAll subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent PNS surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device. | Device | Treatment group |
Primary outcome
Difference of the mean VAS scores of the experimental group and the control group during the random withdrawal period
Time frame: 7 days after the wire implantation test period
(VASEGbase -- VASEGwd) Average - (VASCGbase -- VASCGwd) Average Explanation: VASEGbase was the mean VAS score of subjects in the experimental group at 4 days before the random withdrawal period. VASEGwd was the maximum VAS score of subjects in the experimental group during the random withdrawal period. VASCGbase was the mean VAS score of subjects in the control group at 4 days before the random withdrawal period. The maximum VAS score of subjects in the VASCGwd control group during the random withdrawal period.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous peripheral nerve stimulation system in people with Complications; Prosthesis, Nervous System, Peripheral, Pain, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 28 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Ma, PhD (86-21-25078707, marke72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the mean VAS scores of the experimental group and the control group during the random withdrawal period (time frame: 7 days after the wire implantation test period). 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 28 Jun 2024.