Ignite Creation Date:
2024-05-06 @ 12:40 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03818074
Status:
RECRUITING
Last Update Posted:
2022-10-06
First Post:
2019-01-15
Brief Title:
High Frequency 1000Hz Spinal Cord Stimulation in Neuropathic Pain Patients With Virgin Back
Sponsor:
Barts The London NHS Trust
Organization:
Barts The London NHS Trust
Study Overview
Official Title:
A Prospective Single Centre Pilot Study to Investigate the Response to 1000Hz Frequency in Patients With Spinal Cord Stimulation With Intractable Neuropathic Pain Who Have Not Undergone Spinal Surgery Virgin Back
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal Cord stimulation SCS is a common intervention used in patients who suffer from chronic nerve pain following back surgery This is known as failed back surgery syndrome FBSS Equally the National Institute of Clinical Excellence NICE who work with the NHS recommend suitable medicines and treatments for patients in their guidelines suggest that SCS can be used in patients who have never had back surgery The is no outcome data to define that SCS works in patients with neuropathic back pain therefore this study will provide clinical data to see if this works
SCS delivers mild electrical impulses to the nerves along the spinal cord This blocks the pain pathway from reaching the brain This helps manage the pain experienced the lower back
A common side effect of the conventional system is that patients may experience pins and needles tingling and numbness known as parathesia at site of stimulation This can be particularly uncomfortable for patients However parathesia can be eliminated by changing certain settings on the stimulator This could include increasing the frequency of the stimulator known as high frequency HF This works by delivering energy to site of stimulation below the parathesia threshold so minimal or no parathesia is experienced
Only one study has been completed previously using HF frequency on patients with FBSS The major findings from these studies have found that when compared to conventional SCS uses a frequency of 40-80 Hz that HF has provided better pain relief with minimal or no parathesia Higher frequencies parameters are not completely novel because they have been used in patients who have FBSS However settings of 1000Hz which will be used in this study have not been done in patients who suffer from neuropathic pain and have not had any previous spinal surgery
Therefore the main reason of this study is to investigate the response patients suffering from neuropathic pain and have not had previous spinal surgery have to 1000Hz HF frequency spinal cord stimulation We will also investigate the effect this setting has on the quality of life of the patients
SCS delivers mild electrical impulses to the nerves along the spinal cord This blocks the pain pathway from reaching the brain This helps manage the pain experienced the lower back
A common side effect of the conventional system is that patients may experience pins and needles tingling and numbness known as parathesia at site of stimulation This can be particularly uncomfortable for patients However parathesia can be eliminated by changing certain settings on the stimulator This could include increasing the frequency of the stimulator known as high frequency HF This works by delivering energy to site of stimulation below the parathesia threshold so minimal or no parathesia is experienced
Only one study has been completed previously using HF frequency on patients with FBSS The major findings from these studies have found that when compared to conventional SCS uses a frequency of 40-80 Hz that HF has provided better pain relief with minimal or no parathesia Higher frequencies parameters are not completely novel because they have been used in patients who have FBSS However settings of 1000Hz which will be used in this study have not been done in patients who suffer from neuropathic pain and have not had any previous spinal surgery
Therefore the main reason of this study is to investigate the response patients suffering from neuropathic pain and have not had previous spinal surgery have to 1000Hz HF frequency spinal cord stimulation We will also investigate the effect this setting has on the quality of life of the patients
Detailed Description:
Spinal cord stimulation SCS is a successful treatment in patients with intractable neuropathic pain This therapy is most commonly used in patients who have chronic neuropathic pain following failed surgery known as failed back surgery syndrome FBSS There is evidence from previous studies to demonstrate that SCS can provide a 50- 70 reduction in pain medication and pain scores A randomised controlled study compared SCS with conventional medical management CMM When compared with the CMM group the SCS patients had a 50 pain reduction in their back pain and leg pain The results suggested that patients who received SCS had better pain relief and health related quality of life over a period of 6 to 12 months compared to the CMM group Additionally these patients reported satisfaction in SCS treatment continuous pain relief and clinical improvements in functional capacity and health-related quality of life
On the other hand SCS has been progressively being used in patients with intractable neuropathic pain who have not undergone spinal back surgery Virgin-back The UK NICE guidelines have recommended SCS as a treatment option for patients with intractable neuropathic spinal pain including patients who have not undergone previous spinal surgery NICE 2008
One of the main drawbacks of conventional SCS is the onset of parathesia despite being an effective therapy for neuropathic pain This can cause abnormal sensations or considerable discomfort to the patient during activity or sudden position changes Typically conventional SCS operate at frequencies ranging from 40-80 Hz long pulse widths of 300-500 µsec and amplitudes to stimulate patients pain sensory percept distribution These frequencies are often used because sensory perception is often lost at 300 Hz Current studies have found that delivering stimulating frequencies below the upper limit of what may cause parathesia may reduce discomfort and abnormal sensations increasing the tolerability of SCS treatment Parathesia is considered necessary in order to cover the painful area and provide maximum pain relief However recent research suggests that parathesia may not be necessary for pain relief and in fact that pain awareness can provide full benefits of SCS
Data from PROCO RCT indicates that similar pain relief and improvement in quality of life measures are experienced independent of the type of frequency from 1kHz up to 10kHz used in paraesthesia free SCS therapy when the proper target and dose are identified Further the study showed that 1kHz stimulation provides similar pain relief using significantly less energy than higher frequencies
High frequency HF stimulation is a new promising new stimulation paradigm involving higher frequency lower pulse widths and lower amplitudes when compared to conventional SCS The effectiveness of HF-SCS is controlled by the amount of Neural dose frequency amplitude and pulse width passing the electrodes and reaching the neural tissue resulting in minimal discomfort and damage to the tissues before the definite shape of the impulse
Pre-clinical Data
A study testing the efficacy of kilohertz and conventional SCS was done on rat models during different pain conditions The findings established that higher frequencies can be delivered at lower amplitudes whilst reversing pain behaviours as seen at 50 Hz and at higher intensity of motor threshold
Moreover both conventional and kilohertz frequency SCS forms intensity and frequency-dependant inhibition of mechanical hypersensitivity in animal models of neuropathic pain Different intensities 20 40 and 80 motor threshold and frequencies 50 1kHz and 10kHz were used At each frequency the pulse width was constant It was observed that as frequency was increased the pulse density also increased
Clinical data
Previous randomised control trials have provided evidence that using frequency 1200 Hz and pulses 5 provides efficient relief with HF- SCS
A multi-centre trial previously conducted to see the effects of HF-SCS on patients being delivered up to 10 kHz of stimulation Patients were assessed for pain ratings disability sleep disturbances and satisfaction as well as complication rates for up to six months When results were compared to baseline 88 of patients reported a significant reduction in mean back visual analogue scores VAS from 84 to 27 at six months Seventy four per cent of patients reported more than 50 back pain relief at six months Overall it was concluded that individuals in the trial group with chronic back pain 70 of patients were provided with positive improvement and experienced sustained low back and leg pain relief Substantial improvements were also seen for these patients with disability and sleep disturbances
If clinically considered the NRS has substantially reduced in patients who received HF-SCS than conventional SCS in patients with neuropathic pain and FBSS This suggests that HF may provide relief in virgin-back patients Since there remains limited research in this area therefore the main objective of our study is to investigate the response to 1000Hz frequency following SCS treatment in virgin back patients with intractable lower limb neuropathic pain However based on the PROCO RCT and further WHISPER trial we aim to establish role of microburst and combination therapy in non-responders
Our sample size of 30 patients will allow detection of minimal important difference of 20 on the NRS pain scale at 90 power and alpha of 5 assuming an outcome standard deviation of 25 and attrition rate at 12-months of 30 Patient primary and secondary outcomes at each follow up point will be compared to baseline values Data analyses will take account of the paired nature of the data and use non-independent t-test for continuous outcomes and McNemars test for binary outcomes
The primary objective is to investigate the clinical response to high frequency 1000Hz in patients who are due to have percutaneous spinal cord stimulation for intractable lower limb neuropathic pain
The secondary objective will be to investigate the effect on functionality and quality of life and adverse events at the high frequency group 1000Hz
On the other hand SCS has been progressively being used in patients with intractable neuropathic pain who have not undergone spinal back surgery Virgin-back The UK NICE guidelines have recommended SCS as a treatment option for patients with intractable neuropathic spinal pain including patients who have not undergone previous spinal surgery NICE 2008
One of the main drawbacks of conventional SCS is the onset of parathesia despite being an effective therapy for neuropathic pain This can cause abnormal sensations or considerable discomfort to the patient during activity or sudden position changes Typically conventional SCS operate at frequencies ranging from 40-80 Hz long pulse widths of 300-500 µsec and amplitudes to stimulate patients pain sensory percept distribution These frequencies are often used because sensory perception is often lost at 300 Hz Current studies have found that delivering stimulating frequencies below the upper limit of what may cause parathesia may reduce discomfort and abnormal sensations increasing the tolerability of SCS treatment Parathesia is considered necessary in order to cover the painful area and provide maximum pain relief However recent research suggests that parathesia may not be necessary for pain relief and in fact that pain awareness can provide full benefits of SCS
Data from PROCO RCT indicates that similar pain relief and improvement in quality of life measures are experienced independent of the type of frequency from 1kHz up to 10kHz used in paraesthesia free SCS therapy when the proper target and dose are identified Further the study showed that 1kHz stimulation provides similar pain relief using significantly less energy than higher frequencies
High frequency HF stimulation is a new promising new stimulation paradigm involving higher frequency lower pulse widths and lower amplitudes when compared to conventional SCS The effectiveness of HF-SCS is controlled by the amount of Neural dose frequency amplitude and pulse width passing the electrodes and reaching the neural tissue resulting in minimal discomfort and damage to the tissues before the definite shape of the impulse
Pre-clinical Data
A study testing the efficacy of kilohertz and conventional SCS was done on rat models during different pain conditions The findings established that higher frequencies can be delivered at lower amplitudes whilst reversing pain behaviours as seen at 50 Hz and at higher intensity of motor threshold
Moreover both conventional and kilohertz frequency SCS forms intensity and frequency-dependant inhibition of mechanical hypersensitivity in animal models of neuropathic pain Different intensities 20 40 and 80 motor threshold and frequencies 50 1kHz and 10kHz were used At each frequency the pulse width was constant It was observed that as frequency was increased the pulse density also increased
Clinical data
Previous randomised control trials have provided evidence that using frequency 1200 Hz and pulses 5 provides efficient relief with HF- SCS
A multi-centre trial previously conducted to see the effects of HF-SCS on patients being delivered up to 10 kHz of stimulation Patients were assessed for pain ratings disability sleep disturbances and satisfaction as well as complication rates for up to six months When results were compared to baseline 88 of patients reported a significant reduction in mean back visual analogue scores VAS from 84 to 27 at six months Seventy four per cent of patients reported more than 50 back pain relief at six months Overall it was concluded that individuals in the trial group with chronic back pain 70 of patients were provided with positive improvement and experienced sustained low back and leg pain relief Substantial improvements were also seen for these patients with disability and sleep disturbances
If clinically considered the NRS has substantially reduced in patients who received HF-SCS than conventional SCS in patients with neuropathic pain and FBSS This suggests that HF may provide relief in virgin-back patients Since there remains limited research in this area therefore the main objective of our study is to investigate the response to 1000Hz frequency following SCS treatment in virgin back patients with intractable lower limb neuropathic pain However based on the PROCO RCT and further WHISPER trial we aim to establish role of microburst and combination therapy in non-responders
Our sample size of 30 patients will allow detection of minimal important difference of 20 on the NRS pain scale at 90 power and alpha of 5 assuming an outcome standard deviation of 25 and attrition rate at 12-months of 30 Patient primary and secondary outcomes at each follow up point will be compared to baseline values Data analyses will take account of the paired nature of the data and use non-independent t-test for continuous outcomes and McNemars test for binary outcomes
The primary objective is to investigate the clinical response to high frequency 1000Hz in patients who are due to have percutaneous spinal cord stimulation for intractable lower limb neuropathic pain
The secondary objective will be to investigate the effect on functionality and quality of life and adverse events at the high frequency group 1000Hz
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None