High Frequency (1000Hz) Spinal Cord Stimulation in Neuropathic Pain Patients With Virgin Back

NCT03818074 | Completed DMC FDA Device

• 1 other identifier: 012170
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuropathic Pain; Low Back Pain

Keywords

High Frequency spinal cord stimulation

Outcome Measures

Primary Outcomes (27)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  24 months

• change from baseline EQ-5D-5L scores at 4 weeks

  The EQ-5D is a standardised instrument used to measure health outcome.

  4 weeks

• change from baseline EQ-5D-5L scores at 3 months

  The EQ-5D is a standardised instrument used to measure health outcome.

  3 months.

• change from baseline EQ-5D-5L scores at 6 months

  The EQ-5D is a standardised instrument used to measure health outcome.

  6 months.

• change from baseline EQ-5D-5L scores at 12 months

  The EQ-5D is a standardised instrument used to measure health outcome.

  12 months.

• change from baseline EQ-5D-5L scores at 24 months

  The EQ-5D is a standardised instrument used to measure health outcome.

  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.

  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.

  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.

  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.

  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.

  24 months

• Change from baseline Resource Questionnaire at 12 months

  The resource questionnaire measures the impact of health on employment.

  12 months.

• Change from baseline Resource Questionnaire at 24 months

  The resource questionnaire measures the impact of health on employment.

  24 months.

Study Arms (1)

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.

Device: Boston Wavewriter 1000Hz Spinal cord Stimulation

Interventions

Boston Wavewriter 1000Hz Spinal cord Stimulation DEVICE

High frequency spinal cord stimulation.

Boston Wavewriter (1000Hz) spinal cord stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Vivek Health Mehta

London, EC1A 4NP, United Kingdom

Location

MeSH Terms

Conditions

Neuralgia; Low Back Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Officials

• Kavita Poply, Dr

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patients will be required to adhere to the study and attend all follow up visits. Informed consent and questionnaires will be administered at visit 0. They will be followed up 4, 12, 24 weeks and 12 months, 24 months after their SCS permanent implant. Questionnaires will be administered at each visit.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: January 28, 2019
• Study Start: October 9, 2018
• Primary Completion: July 7, 2024
• Study Completion: July 7, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)