Neuropathic PainNCT03818074
High Frequency (1000Hz) Spinal Cord Stimulation in Neuropathic Pain Patients With Virgin Back
A study testing Boston Wavewriter 1000Hz Spinal cord Stimulation in people with Neuropathic Pain and Low Back Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neuropathic Pain, Low Back Pain
- What is being tested?
- Boston Wavewriter 1000Hz Spinal cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Oct 2018to 7 Jul 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70
- Chronic Back Pain (≥ 6 mo) with NRS ≥ 6/10
- Back pain predominant over leg pain (if leg pain present)
- Failure to respond to conventional treatment including intense rehababilitation and facet/MBB/SI interventions
- No prior spinal surgery for the back and leg pain on the same site of implantation.
- Presence of lumbar degenerative disc disease
Show all 12Show fewer
- Absence of spinal pathology which would require surgical intervention
- Stable dose of opioids and anti-neuropathic drugs for ≥ 6 months
- Patients with intractable lumbar neuropathic pain who are due to receive Percutaneous Spinal Cord Stimulation as part of their standard treatment per NICE HTA guidance 159 at Barts Health NHS Hospitals.
- Patients who have given their written informed consent.
- Female patients of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test.
- Patients must be able to communicate in English in order to complete validated questionnaires written in English.
Who cannot join
- Patients not able to comply or understand the study-related requirements
- Active alcohol, recreational or prescription drug abuse in the last 3 months.
- Unwilling to reduce excessive pain medications
- A medical/psychiatric condition that could interfere with study procedures, accurate pain reporting, and/or confound study outcomes
- Patients with diabetes or any current diagnosis of progressive neurological disease (i.e., CIDP, Multiple sclerosis)
- Immuno-compromised/high risk for surgical infection
Show all 13Show fewer
- Pregnant and/or breast feeding
- Terminal illness with anticipated survival < 12 months
- Patients who have been part of a previous spinal cord stimulation trial
- Currently implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator)
- Untreated clinically significant sleep disorder as judged by the CI.
- Unresolved issues of secondary gain (i.e., litigation)
- Participation in another clinical study in the last 30 days that would confound data.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
Read the 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 patient's 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 8.4 to 2.7 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 2.0 on the NRS pain scale at 90% power and alpha of 5%, assuming an outcome standard deviation of 2.5 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 McNemar's test for binary outcomes.
- The primary objective is to investigate the clinical response to high frequency (1,000Hz) 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)
- Conditions
- Neuropathic Pain, Low Back Pain
- Being tested
- Boston Wavewriter 1000Hz Spinal cord Stimulation
- Keywords
- High Frequency spinal cord stimulation
- Medical subject headings
- Neuralgia, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boston Wavewriter 1000Hz Spinal cord StimulationDevice
High frequency spinal cord stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Boston Wavewriter (1000Hz) spinal cord stimulation | Experimental | To investigate the response to high frequency (1000Hz) in patients who are due to have spinal cord stimulation for neuropathic back pain. Receives: Device: Boston Wavewriter 1000Hz Spinal cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline numerical Rating Score (NRS) at 4 weeks
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Measured: 4 weeks
change from baseline numerical Rating Score (NRS) at 3 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Measured: 3 months
Change from baseline numerical Rating Score (NRS) at 6 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Measured: 6 months
Change from baseline numerical Rating Score (NRS) at 12 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Measured: 12 months
Change from baseline numerical Rating Score (NRS) at 24 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Measured: 24 months
Change from baseline Oswestry Disability Index (ODI) scores at 4 weeks
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: 4 weeks
Change from baseline Oswestry Disability Index (ODI) scores at 3 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: 3 months
Change from baseline Oswestry Disability Index (ODI) scores at 6 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: 6 months
Change from baseline Oswestry Disability Index (ODI) scores at 12 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: 12 months
Change from baseline Oswestry Disability Index (ODI) scores at 24 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: 24 months
Change from baseline Patient's Global Impression of change (PGIC) scores to 4 weeks
A standard seven point scale would be used to assess the SCS outcome.
Measured: 4 weeks
Change from baseline Patient's Global Impression of change (PGIC) scores to 3 months
A standard seven point scale would be used to assess the SCS outcome.
Measured: 3 months
Change from baseline Patient's Global Impression of change (PGIC) scores to 6 months
A standard seven point scale would be used to assess the SCS outcome.
Measured: 6 months
Change from baseline Patient's Global Impression of change (PGIC) scores to 12 months
A standard seven point scale would be used to assess the SCS outcome.
Measured: 12 months
Change from baseline Patient's Global Impression of change (PGIC) scores to 24 months
A standard seven point scale would be used to assess the SCS outcome.
Measured: 24 months
change from baseline EQ-5D-5L scores at 4 weeks
The EQ-5D is a standardised instrument used to measure health outcome.
Measured: 4 weeks
change from baseline EQ-5D-5L scores at 3 months
The EQ-5D is a standardised instrument used to measure health outcome.
Measured: 3 months.
change from baseline EQ-5D-5L scores at 6 months
The EQ-5D is a standardised instrument used to measure health outcome.
Measured: 6 months.
change from baseline EQ-5D-5L scores at 12 months
The EQ-5D is a standardised instrument used to measure health outcome.
Measured: 12 months.
change from baseline EQ-5D-5L scores at 24 months
The EQ-5D is a standardised instrument used to measure health outcome.
Measured: 24 months.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 4 weeks
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Measured: 4 weeks
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 3 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Measured: 3 months
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 6 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Measured: 6 months
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 12 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Measured: 12 months
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 24 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Measured: 24 months
Change from baseline Resource Questionnaire at 12 months
The resource questionnaire measures the impact of health on employment.
Measured: 12 months.
Change from baseline Resource Questionnaire at 24 months
The resource questionnaire measures the impact of health on employment.
Measured: 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start9 Oct 2018
- Primary completion7 Jul 2024
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- To investigate the clinical response to high frequency (1,000Hz) in patients who are due to have percutaneous spinal cord stimulation for intractable back and lower limb neuropathic pain
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Kavita Poply, Dr, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03818074
- Sponsor's protocol ID
- 012170
- Status last verified
- Nov 2024
- First submitted
- 15 Jan 2019
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: We will follow the policies laid by the local information governance team at Barts Health NHS Trust and NHS code of Confidentiality in accordance to the data protection act.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03818074
- Acronym / sponsor ID
- 012170
- Conditions
- Neuropathic Pain, Low Back Pain
- Keywords
- High Frequency spinal cord stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 28 Jan 2019 (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.
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.
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 patient's 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 8.4 to 2.7 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 2.0 on the NRS pain scale at 90% power and alpha of 5%, assuming an outcome standard deviation of 2.5 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 McNemar's test for binary outcomes.
- The primary objective is to investigate the clinical response to high frequency (1,000Hz) 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- To investigate the clinical response to high frequency (1,000Hz) in patients who are due to have percutaneous spinal cord stimulation for intractable back and lower limb neuropathic pain
| Arm | Type | Receives |
|---|---|---|
| Boston Wavewriter (1000Hz) spinal cord stimulation | Experimental | Device: Boston Wavewriter 1000Hz Spinal cord StimulationTo investigate the response to high frequency (1000Hz) in patients who are due to have spinal cord stimulation for neuropathic back pain. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18-70
- Chronic Back Pain (≥ 6 mo) with NRS ≥ 6/10
- Back pain predominant over leg pain (if leg pain present)
- Failure to respond to conventional treatment including intense rehababilitation and facet/MBB/SI interventions
- No prior spinal surgery for the back and leg pain on the same site of implantation.
Key exclusion criteria (13 listed)
- Patients not able to comply or understand the study-related requirements
- Active alcohol, recreational or prescription drug abuse in the last 3 months.
- Unwilling to reduce excessive pain medications
- A medical/psychiatric condition that could interfere with study procedures, accurate pain reporting, and/or confound study outcomes
- Patients with diabetes or any current diagnosis of progressive neurological disease (i.e., CIDP, Multiple sclerosis)
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 |
|---|---|---|
| Boston Wavewriter 1000Hz Spinal cord StimulationHigh frequency spinal cord stimulation. | Device | Boston Wavewriter (1000Hz) spinal cord stimulation |
Primary outcome
Change from baseline numerical Rating Score (NRS) at 4 weeks
Time frame: 4 weeks
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
change from baseline numerical Rating Score (NRS) at 3 months
Time frame: 3 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline numerical Rating Score (NRS) at 6 months
Time frame: 6 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline numerical Rating Score (NRS) at 12 months
Time frame: 12 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline numerical Rating Score (NRS) at 24 months
Time frame: 24 months
NRS will be used to measure the pain intensity, enabling the patient to express the severity of pain by giving it a numerical value from 0 to 10 on an 11-point numerical pain rating scale. An average overall pain score will be recorded over the last 7 days.
Change from baseline Oswestry Disability Index (ODI) scores at 4 weeks
Time frame: 4 weeks
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Oswestry Disability Index (ODI) scores at 3 months
Time frame: 3 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Oswestry Disability Index (ODI) scores at 6 months
Time frame: 6 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Oswestry Disability Index (ODI) scores at 12 months
Time frame: 12 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Oswestry Disability Index (ODI) scores at 24 months
Time frame: 24 months
A commonly used scale for back pain patients with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Change from baseline Patient's Global Impression of change (PGIC) scores to 4 weeks
Time frame: 4 weeks
A standard seven point scale would be used to assess the SCS outcome.
Change from baseline Patient's Global Impression of change (PGIC) scores to 3 months
Time frame: 3 months
A standard seven point scale would be used to assess the SCS outcome.
Change from baseline Patient's Global Impression of change (PGIC) scores to 6 months
Time frame: 6 months
A standard seven point scale would be used to assess the SCS outcome.
Change from baseline Patient's Global Impression of change (PGIC) scores to 12 months
Time frame: 12 months
A standard seven point scale would be used to assess the SCS outcome.
Change from baseline Patient's Global Impression of change (PGIC) scores to 24 months
Time frame: 24 months
A standard seven point scale would be used to assess the SCS outcome.
change from baseline EQ-5D-5L scores at 4 weeks
Time frame: 4 weeks
The EQ-5D is a standardised instrument used to measure health outcome.
change from baseline EQ-5D-5L scores at 3 months
Time frame: 3 months.
The EQ-5D is a standardised instrument used to measure health outcome.
change from baseline EQ-5D-5L scores at 6 months
Time frame: 6 months.
The EQ-5D is a standardised instrument used to measure health outcome.
change from baseline EQ-5D-5L scores at 12 months
Time frame: 12 months.
The EQ-5D is a standardised instrument used to measure health outcome.
change from baseline EQ-5D-5L scores at 24 months
Time frame: 24 months.
The EQ-5D is a standardised instrument used to measure health outcome.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 4 weeks
Time frame: 4 weeks
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 3 months
Time frame: 3 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 6 months
Time frame: 6 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 12 months
Time frame: 12 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Pain and Sleep 3 point index (PSQ-3) at 24 months
Time frame: 24 months
The PSQ-3 is an instrument that measures the quality of sleep over a month.
Change from baseline Resource Questionnaire at 12 months
Time frame: 12 months.
The resource questionnaire measures the impact of health on employment.
Change from baseline Resource Questionnaire at 24 months
Time frame: 24 months.
The resource questionnaire measures the impact of health on employment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No. We will follow the policies laid by the local information governance team at Barts Health NHS Trust and NHS code of Confidentiality in accordance to the data protection act.
Related trials for Neuropathic Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
Complex Regional Pain Syndrome, Chronic Pain
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
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.
Kavita Poply, Dr principal investigator
Barts & The London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boston Wavewriter 1000Hz Spinal cord Stimulation in people with Neuropathic Pain and Low Back Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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 12 inclusion and 13 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: finished, as of the sponsor's last update on 5 Nov 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline numerical Rating Score (NRS) at 4 weeks (time frame: 4 weeks). The study lists 27 primary outcomes in all. 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 5 Nov 2024.