Neuropathic Low Back PainCHRONOSNCT04943770
Evaluating the Effect of Spinal Cord Stimulation Frequency on Fast-Acting Sub-perception Therapy (FAST) for Chronic Pain
An observational study of Neuropathic Low Back Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The study design is prospective, post-market, exploratory, single-centre, rate randomised, double-blinded (subject, evaluator blinded; programmer un-blinded). The study is designed to evaluate the wash-in and wash-out time of FAST (Fast Acting Sub-perception Therapy) at 90 Hz and various frequencies above and below 90… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Low Back Pain
- What is being tested?
- Spinal cord stimulator implant, Healing period and WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2022to 31 Jul 2023
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients suffering from neuropathic back pain with or without additional neuropathic leg pain that have not received any benefit from conventional medical management.
Who may be able to join
- The subject is between 18 and 75 years of age when written informed consent is obtained.
- Complaint of persistent or recurrent low back pain, with or without equal or lesser leg pain, for at least 90 days prior to Screen.
- Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy.)
- Diagnosed with chronic neuropathic pain of the low back and legs (of neuropathic origin only).
- Eligible candidate for SCS from a psychological and psychiatric standpoint as determined prior to Baseline Visit, per site's routine screening process No back surgery within 6 months prior to Screening.
- Average low back pain intensity, during the position/activity, which routinely causes worst pain, of 5 or greater on a 0-10 numerical rating scale during Baseline period based on eDiary.
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- If taking prescription opioids for primary chronic pain complaint (low back and/or leg pain), must have been on a stable prescription (same drug(s) and dose(s)) 30 days prior to Screening to a total of less than 180 mg Oral Morphine equivalent.
- Willing and able to comply with all protocol-required procedures and assessments/evaluations (e.g. willing to comply with opioid prescription lock from the Baseline visit through End of Rate Randomization and protocol required stimulation parameter locks, complete daily eDiary).
- If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening.
- Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
Who cannot join
- Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
- Have untreated major psychiatric comorbidity, serious drug related behaviour issues.
- Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator).
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
- Currently on any anticoagulant medications that cannot be discontinued during perioperative period
- Current condition associated with risk of immunocompromised that might increase risk of infection during study duration.
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- A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
- Primary pain complaint of vascular origin (e.g. peripheral vascular disease). Spinal pain secondary to neoplasm, infection, autoimmune disorder with spinal involvement, or a spinal metabolic disorder.
- Clinically significant lumbosacral stenosis which would interfere with lead placement
- Prior history of lumbar-sacral spine fusion
- Any pain-related diagnosis or medical/psychological condition that, in the clinician's best judgment might confound reporting of study outcomes (e.g. pelvic pain, angina pain, chronic migraine.
- Radiographic evidence of spinal instability requiring fusion
- Terminal illness with anticipated survival 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Single-centre, Double-blind, Randomised Study to Evaluate the Effect of Spinal Cord Stimulation Frequency on wash-in/Wash-out Time and Clinical Outcomes in Subjects Using Fast-Acting Sub-perception Therapy (FAST) for Chronic Pain
The study design is prospective, post-market, exploratory, single-centre, rate randomised, double-blinded (subject, evaluator blinded; programmer un-blinded). The study is designed to evaluate the wash-in and wash-out time of FAST (Fast Acting Sub-perception Therapy) at 90 Hz and various frequencies above and below 90 Hz.
A prospective study design will eliminate the bias associated with case selection in a retrospective review and will ensure that identical procedures are followed for data capture and review.
Read more
Randomization of rates will be used to minimise the sequence effects and the impact of carryover effects, as well as addressing issues that may be related to order effect.
The electronic diary will be used to log the subjects' pain intensity and medication usage. Additionally, the numerical rating scale for measuring pain intensity is a validated measure and has been used in other randomized controlled trials to measure the outcomes of spinal cord stimulation (SCS).
The electronic real-time NRS (Numerical rating score) recording will be used to log the subjects' pain intensity and time during wash-in evaluation session.
This study aims to evaluate pain relief and wash-in/wash-out frequency sensitivity using FAST at different stimulation rates. The different randomization period included in the study design allows for comparing these treatments using one of the stimulation rates as an active control.
Read the detailed description
Chronic Pain Background
Chronic intractable pain is a significant worldwide health issue, which consumes considerable healthcare resources and heavily impacts the quality of life for many patients. It is often defined as pain persisting for at least 6 months and not responding to conservative treatment(s). Chronic pain may be induced by current or past nerve injury and causes significant disability. People affected by such condition often experience reduced health-related quality of life, reduced ability to engage in activities of daily living, depression, sleep disturbances and weight gain due to the adoption of a sedentary lifestyle.
Typical entry into the pain management continuum includes over-the-counter medications, followed by physical therapy and complementary medicine. Interventional Pain management, Interdisciplinary pain management and surgery are attempted next and are often followed by long-term oral opioids intake. Active implantable options, including Spinal Cord Stimulation (SCS), lie within the continuum of chronic pain therapies and can be recommended as an alternative to long-term opioids intake (as recommended by National Institute of Clinical Excellence- NICE).
Spinal Cord Stimulation (SCS)
SCS refers to the application of small amounts of electrical energy, often via wires (a.k.a. "leads") to stimulate nerves in the spinal cord and reduce chronic pain symptoms. SCS is a less invasive treatment option for chronic pain that has generally been reserved for patients who have failed multiple, and sometimes all, conservative chronic pain therapies. With SCS, an implanted pulse generator (IPG) delivers electrical current to leads implanted in the epidural space at specific spinal level. Electrical currents stimulates nerves and can be shaped to optimise stimulation of fibres innervating the painful locations, thereby reducing pain sensation.
For decades, paresthesia-based SCS has been used to treat chronic pain. The classic approach typically uses frequencies between 40-100 Hz and enables a relatively straightforward identification and energy-efficient stimulation of the so-called therapeutic "sweet-spot". However, a potential drawback of this method of treatment is that patients using paresthesia-based SCS must endure paresthesias ("tingling") which, although may not always be bothersome and even pleasant to some, is an aspect that some may prefer to avoid.
Although, within the last 10 years, SCS device technologies have expanded considerably. One example is the introduction of higher stimulation frequency (i.e., 10 kHz) and amplitudes below perception threshold, enabling patients to obtain pain relief without experiencing paresthesia. This approach is known as sub-perception SC. However, this method is very energy-intensive, requires patients to recharge every 1-2 days and exhibits a slow "wash-in" time (i.e., the time between therapy activation and relief from pain). Conventional sub-perception methodologies have the desirable property of not requiring the patient to feel paresthesia but have some notable drawbacks. In particular, (1) patients leave the clinic still awaiting relief and hoping that one of the programs provided will be effective, (2) the sweet-spot is assessed via a "blind" search, an approach that limits the number of program settings testable on each patient and calling into question whether or not the final settings are optimal, (3) and in many cases the programs require much more energy than a paresthesia-based program.
As part of an effort to improve patients' experience and outcomes associated with the utilization of sub-perception SCS, the investigators hypothesised that there might be a putative relationship between the following: a) the specific location in which a sub-perception stimulation field is most effective and b) the paresthesia that overlaps the physical area(s) of pain as reported by each patient. Evaluation of this hypothesis led the investigators to develop a novel approach for implementation of sub-perception SCS, which is termed "Fast Acting Sub-perception Therapy" (FAST). This new methodology offers all the advantages provided by both paresthesia- and sub-perception-based SCS while simultaneously mitigating the potential downsides typically associated with each of these modalities when they are applied independently.
Study objectives and Endpoints
Primary objective
The primary objective of this study is to evaluate the wash-in/wash-out times of Fast-Acting Sub-perception Therapy (FAST) and best clinical outcomes as measured by mean reported pain on Numerical Rating Scale at 90 Hz and with frequencies above and below 90 Hz.
Secondary objective
The secondary objective will be to investigate the effect on functionality, quality of life, therapy longevity (3 and 6-month) and adverse events in the study population.
Primary endpoint
There are no Primary Endpoints for this exploratory study.
Exploratory endpoint
The following exploratory endpoints will be collected in this study:
- Wash-in time of overall pain intensity (RT-NRS) of each Rate Randomization (A, B, C, D)
- Wash-out time of lower back, legs pain and overall pain intensity (ED-NRS) of each Rate Randomization (A, B, C, D)
- Change in average lower back, legs pain and overall pain intensity (ED-NRS) from Baseline to end of each Randomization (A, B, C, D) and Long-Term Follow-up periods
- Treatment Satisfaction at end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (PSWT)
- Global impression of change at end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (PGIC)
- Change in disability from Baseline to end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (ODIv2.1a)
- Change in Quality of life from Baseline to end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (EQ-5D-5L)
- Change in sleep quality from Baseline to end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (PSQ3)
- Subject preferred program at Long-Term Follow-up period (Preference Questionnaire)
- Pain/paresthesia overlap for each tested configuration at Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (Pain/Paresthesia drawing
- Conditions
- Neuropathic Low Back Pain
- Being tested
- Spinal cord stimulator implant, Healing period, WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system
- Keywords
- spinal cord stimulation, sub-perception, low back pain, wash in/wash out, neuropathic pain
- Medical subject headings
- Low Back Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal cord stimulator implantProcedure or surgery
Also called Boston Scientific Wavewriter
Patients will undergo spinal cord implant procedures as per standard of care and be implanted with the WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system.
Implant Procedures will be followed by a healing period (4-6 weeks) during which patients will be offered therapy (up to one 1Khz). Patients will then be randomised to receive therapy at four different rates (A, B, C, D) in no particular order for 3-6 weeks each. Patients will then be followed up at 3 and 6 months after the last randomization visit.
Healing periodDiagnostic test
Acute opioid pain medications may be continued. No additional scheduled assessments will be completed during this period.
WaveWriter™ Alpha Spinal Cord Stimulator (SCS) systemDevice
Patients will then be randomised to receive therapy (up to 1KHz) at four different rates in no particular order for 3-6 weeks each. Patients will then be followed up at 3 and 6 months after the last randomization visit.
| Study group | Role | What they receive |
|---|---|---|
| WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system | Patients will be randomised 4:4 to a specific stimulating rates order (A, B, C, D) for approx. 3-6 weeks per rate (12-24 weeks in total). Each period is followed by a wash-out phase.
At each frequency systematic assessment of the sweet-spot(s) will be performed. Various pulse width and amplitude values may be used to optimize therapy (up to 1KHz). These programmes will be saved in the subject's remote control based on the pre-generated rate randomization sequence. Receives: Procedure: Spinal cord stimulator implant; Diagnostic Test: Healing period; Device: WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating scale
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Measured: Baseline- patient visit at start of the study
Numerical Rating scale for Randomisation Arm A
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Measured: up to 6 weeks
Numerical Rating scale for Randomisation Arm B
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Measured: up to 6 weeks
Numerical Rating scale for Randomisation Arm C
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Measured: up to 6 weeks
Numerical Rating scale for Randomisation Arm D
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Measured: up to 6 weeks
Numerical Rating scale
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Measured: 3 months post-randomisation
Numerical Rating scale
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Measured: 6 months post randomisation
Oswestry Disability Index (ODI)
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: Baseline
Oswestry Disability Index (ODI) for Randomisation Arm A
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: up to 6 weeks
Oswestry Disability Index (ODI) for Randomisation Arm B
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: up to 6 weeks
Oswestry Disability Index (ODI) for Randomisation Arm C
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: up to 6 weeks
Oswestry Disability Index (ODI) for Randomisation Arm D
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: up to 6 weeks
Oswestry Disability Index (ODI)
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: At 3 months post randomisation
Oswestry Disability Index (ODI)
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Measured: At 6 months post randomisation
Patient Global Impression of Change (PGI-C) for Randomisation arm A
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Measured: up to 6 weeks
Patient Global Impression of Change (PGI-C) for Randomisation arm B
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Measured: up to 6 weeks
Patient Global Impression of Change (PGI-C) for Randomisation arm C
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Measured: up to 6 weeks
Patient Global Impression of Change (PGI-C) for Randomisation arm D
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Measured: up to 6 weeks
Patient Global Impression of Change (PGI-C)
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Measured: At 3 Months post randomisation
Patient Global Impression of Change (PGI-C)
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Measured: At 6 Months post randomisation
EQ-5D 5 Level (EQ-5D-5L)
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Measured: Baseline
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm A
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Measured: up to 6 weeks
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm B
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Measured: Up to 6 weeks
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm C
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Measured: up to 6 weeks
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm D
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Measured: up to 6 weeks
EQ-5D 5 Level (EQ-5D-5L)
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Measured: At 3 months post- randomisation
EQ-5D 5 Level (EQ-5D-5L)
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Measured: At 6 months post- randomisation
Pain and sleep index 3 (PSQ-3)
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Measured: Baseline
Pain and sleep index 3 for Randomisation Arm A
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Measured: up to 6 weeks
Pain and sleep index 3 for Randomisation Arm B
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Measured: up to 6 weeks
Pain and sleep index 3 for Randomisation Arm C
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Measured: up to 6 weeks
Pain and sleep index 3 for Randomisation Arm D
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Measured: up to 6 weeks
Pain and sleep index 3
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Measured: At 3 months post randomisation
Pain and sleep index 3
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Measured: At 6 months post randomisation
Pain Drawing
Pain drawing will be used to help patients highlight all the body areas affected by neuropathic pain on a printed dermatome map. It will be collected at the baseline.
Measured: Baseline
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm A
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Measured: up to 6 weeks
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm B
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Measured: up to 6 weeks
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm C
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Measured: up to 6 weeks
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm D
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Measured: up to 6 weeks
Patient Satisfaction with Treatment (PSWT)
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Measured: At 3 months post randomisation
Patient Satisfaction with Treatment (PSWT)
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Measured: At 6 months post randomisation
Electronic pain diary (e-diary)
The patient will be asked to collect information about their pain daily with an e-Diary. A paper version of the diary will be included as a backup if the e-Diary malfunctions or the patient experiences difficulties with the e-Diary recordings.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start1 Oct 2022 (estimated)
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Why it stopped: COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neuropathic Low Back 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 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
- Vivek Mehta, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943770
- Sponsor's protocol ID
- 281237
- Acronym
- CHRONOS
- Status last verified
- Nov 2024
- First submitted
- 3 Apr 2020
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This study will be registered with the Trust Information Governance Manager at Bart's Health NHS Trust, ensuring the confidentiality of personal data. A signed declaration form (data protection form) of the group to comply with the Data Protection Act and the Department of Health Code of Confidentiality will be applied.
Publications
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery. 2006 Mar;58(3):481-96; discussion 481-96. doi: 10.1227/01.NEU.0000192162.99567.96.
PubMed 16528188Owusu S, Huynh A, Gruenthal E, Prusik J, Owusu-Sarpong S, Cherala R, Peng S, Pilitsis JG, McCallum SE. Prospective Evaluation of Patient Usage of Above and Below Threshold Waveforms With Traditional Spinal Cord Stimulation Devices. Neuromodulation. 2017 Aug;20(6):567-574. doi: 10.1111/ner.12633. Epub 2017 Jul 11.
PubMed 28699301Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774.
PubMed 26218762
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
- Prospective Single-centre, Double-blind, Randomised Study to Evaluate the Effect of Spinal Cord Stimulation Frequency on wash-in/Wash-out Time and Clinical Outcomes in Subjects Using Fast-Acting Sub-perception Therapy (FAST) for Chronic Pain
- ClinicalTrials.gov ID
- NCT04943770
- Acronym / sponsor ID
- CHRONOS / 281237
- Conditions
- Neuropathic Low Back Pain
- Keywords
- spinal cord stimulation, sub-perception, low back pain, wash in/wash out, neuropathic pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 29 Jun 2021 (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.
The study design is prospective, post-market, exploratory, single-centre, rate randomised, double-blinded (subject, evaluator blinded; programmer un-blinded). The study is designed to evaluate the wash-in and wash-out time of FAST (Fast Acting Sub-perception Therapy) at 90 Hz and various frequencies above and below 90 Hz.
A prospective study design will eliminate the bias associated with case selection in a retrospective review and will ensure that identical procedures are followed for data capture and review.
Randomization of rates will be used to minimise the sequence effects and the impact of carryover effects, as well as addressing issues that may be related to order effect.
The electronic diary will be used to log the subjects' pain intensity and medication usage. Additionally, the numerical rating scale for measuring pain intensity is a validated measure and has been used in other randomized controlled trials to measure the outcomes of spinal cord stimulation (SCS).
The electronic real-time NRS (Numerical rating score) recording will be used to log the subjects' pain intensity and time during wash-in evaluation session.
This study aims to evaluate pain relief and wash-in/wash-out frequency sensitivity using FAST at different stimulation rates. The different randomization period included in the study design allows for comparing these treatments using one of the stimulation rates as an active control.
Detailed description
Chronic Pain Background
Chronic intractable pain is a significant worldwide health issue, which consumes considerable healthcare resources and heavily impacts the quality of life for many patients. It is often defined as pain persisting for at least 6 months and not responding to conservative treatment(s). Chronic pain may be induced by current or past nerve injury and causes significant disability. People affected by such condition often experience reduced health-related quality of life, reduced ability to engage in activities of daily living, depression, sleep disturbances and weight gain due to the adoption of a sedentary lifestyle.
Typical entry into the pain management continuum includes over-the-counter medications, followed by physical therapy and complementary medicine. Interventional Pain management, Interdisciplinary pain management and surgery are attempted next and are often followed by long-term oral opioids intake. Active implantable options, including Spinal Cord Stimulation (SCS), lie within the continuum of chronic pain therapies and can be recommended as an alternative to long-term opioids intake (as recommended by National Institute of Clinical Excellence- NICE).
Spinal Cord Stimulation (SCS)
SCS refers to the application of small amounts of electrical energy, often via wires (a.k.a. "leads") to stimulate nerves in the spinal cord and reduce chronic pain symptoms. SCS is a less invasive treatment option for chronic pain that has generally been reserved for patients who have failed multiple, and sometimes all, conservative chronic pain therapies. With SCS, an implanted pulse generator (IPG) delivers electrical current to leads implanted in the epidural space at specific spinal level. Electrical currents stimulates nerves and can be shaped to optimise stimulation of fibres innervating the painful locations, thereby reducing pain sensation.
For decades, paresthesia-based SCS has been used to treat chronic pain. The classic approach typically uses frequencies between 40-100 Hz and enables a relatively straightforward identification and energy-efficient stimulation of the so-called therapeutic "sweet-spot". However, a potential drawback of this method of treatment is that patients using paresthesia-based SCS must endure paresthesias ("tingling") which, although may not always be bothersome and even pleasant to some, is an aspect that some may prefer to avoid.
Although, within the last 10 years, SCS device technologies have expanded considerably. One example is the introduction of higher stimulation frequency (i.e., 10 kHz) and amplitudes below perception threshold, enabling patients to obtain pain relief without experiencing paresthesia. This approach is known as sub-perception SC. However, this method is very energy-intensive, requires patients to recharge every 1-2 days and exhibits a slow "wash-in" time (i.e., the time between therapy activation and relief from pain). Conventional sub-perception methodologies have the desirable property of not requiring the patient to feel paresthesia but have some notable drawbacks. In particular, (1) patients leave the clinic still awaiting relief and hoping that one of the programs provided will be effective, (2) the sweet-spot is assessed via a "blind" search, an approach that limits the number of program settings testable on each patient and calling into question whether or not the final settings are optimal, (3) and in many cases the programs require much more energy than a paresthesia-based program.
As part of an effort to improve patients' experience and outcomes associated with the utilization of sub-perception SCS, the investigators hypothesised that there might be a putative relationship between the following: a) the specific location in which a sub-perception stimulation field is most effective and b) the paresthesia that overlaps the physical area(s) of pain as reported by each patient. Evaluation of this hypothesis led the investigators to develop a novel approach for implementation of sub-perception SCS, which is termed "Fast Acting Sub-perception Therapy" (FAST). This new methodology offers all the advantages provided by both paresthesia- and sub-perception-based SCS while simultaneously mitigating the potential downsides typically associated with each of these modalities when they are applied independently.
Study objectives and Endpoints
Primary objective
The primary objective of this study is to evaluate the wash-in/wash-out times of Fast-Acting Sub-perception Therapy (FAST) and best clinical outcomes as measured by mean reported pain on Numerical Rating Scale at 90 Hz and with frequencies above and below 90 Hz.
Secondary objective
The secondary objective will be to investigate the effect on functionality, quality of life, therapy longevity (3 and 6-month) and adverse events in the study population.
Primary endpoint
There are no Primary Endpoints for this exploratory study.
Exploratory endpoint
The following exploratory endpoints will be collected in this study:
- Wash-in time of overall pain intensity (RT-NRS) of each Rate Randomization (A, B, C, D)
- Wash-out time of lower back, legs pain and overall pain intensity (ED-NRS) of each Rate Randomization (A, B, C, D)
- Change in average lower back, legs pain and overall pain intensity (ED-NRS) from Baseline to end of each Randomization (A, B, C, D) and Long-Term Follow-up periods
- Treatment Satisfaction at end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (PSWT)
- Global impression of change at end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (PGIC)
- Change in disability from Baseline to end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (ODIv2.1a)
- Change in Quality of life from Baseline to end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (EQ-5D-5L)
- Change in sleep quality from Baseline to end of each Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (PSQ3)
- Subject preferred program at Long-Term Follow-up period (Preference Questionnaire)
- Pain/paresthesia overlap for each tested configuration at Rate Randomization (A, B, C, D) and Long-Term Follow-up periods (Pain/Paresthesia drawing
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system | – | Procedure: Spinal cord stimulator implant, Diagnostic Test: Healing period, Device: WaveWriter™ Alpha Spinal Cord Stimulator (SCS) systemPatients will be randomised 4:4 to a specific stimulating rates order (A, B, C, D) for approx. 3-6 weeks per rate (12-24 weeks in total). Each period is followed by a wash-out phase. At each frequency systematic assessment of the sweet-spot(s) will be performed. Various pulse width and amplitude values may be used to optimize therapy (up to 1KHz). These programmes will be saved in the subject's remote control based on the pre-generated rate randomization sequence. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from neuropathic back pain with or without additional neuropathic leg pain that have not received any benefit from conventional medical management.
Key inclusion criteria (10 listed)
- The subject is between 18 and 75 years of age when written informed consent is obtained.
- Complaint of persistent or recurrent low back pain, with or without equal or lesser leg pain, for at least 90 days prior to Screen.
- Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy.)
- Diagnosed with chronic neuropathic pain of the low back and legs (of neuropathic origin only).
- Eligible candidate for SCS from a psychological and psychiatric standpoint as determined prior to Baseline Visit, per site's routine screening process No back surgery within 6 months prior to Screening.
Key exclusion criteria (13 listed)
- Significant cognitive impairment at Screening that, in the opinion of the Investigator, would reasonably be expected to impair the study candidates to participate in the study
- Have untreated major psychiatric comorbidity, serious drug related behaviour issues.
- Previous spinal cord stimulation trial or is already implanted with an active implantable device(s) (e.g. pacemaker, drug pump, implantable pulse generator).
- Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study
- Currently on any anticoagulant medications that cannot be discontinued during perioperative period
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 stimulator implantAlso: Boston Scientific WavewriterPatients will undergo spinal cord implant procedures as per standard of care and be implanted with the WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system. Implant Procedures will be followed by a healing period (4-6 weeks) during which patients will be offered therapy (up to one 1Khz). Patients will then be randomised to receive therapy at four different rates (A, B, C, D) in no particular order for 3-6 weeks each. Patients will then be followed up at 3 and 6 months after the last randomization visit. | Procedure or surgery | WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system |
| Healing periodAcute opioid pain medications may be continued. No additional scheduled assessments will be completed during this period. | Diagnostic test | WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system |
| WaveWriter™ Alpha Spinal Cord Stimulator (SCS) systemPatients will then be randomised to receive therapy (up to 1KHz) at four different rates in no particular order for 3-6 weeks each. Patients will then be followed up at 3 and 6 months after the last randomization visit. | Device | WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system |
Primary outcome
Numerical Rating scale
Time frame: Baseline- patient visit at start of the study
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Numerical Rating scale for Randomisation Arm A
Time frame: up to 6 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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Numerical Rating scale for Randomisation Arm B
Time frame: up to 6 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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Numerical Rating scale for Randomisation Arm C
Time frame: up to 6 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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Numerical Rating scale for Randomisation Arm D
Time frame: up to 6 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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Numerical Rating scale
Time frame: 3 months post-randomisation
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Numerical Rating scale
Time frame: 6 months post randomisation
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 with 0 being no pain at all and 10 being the worst pain imaginable. An average overall score, back pain score, and leg pain score will be recorded.
Oswestry Disability Index (ODI)
Time frame: Baseline
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Oswestry Disability Index (ODI) for Randomisation Arm A
Time frame: up to 6 weeks
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Oswestry Disability Index (ODI) for Randomisation Arm B
Time frame: up to 6 weeks
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Oswestry Disability Index (ODI) for Randomisation Arm C
Time frame: up to 6 weeks
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Oswestry Disability Index (ODI) for Randomisation Arm D
Time frame: up to 6 weeks
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Oswestry Disability Index (ODI)
Time frame: At 3 months post randomisation
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Oswestry Disability Index (ODI)
Time frame: At 6 months post randomisation
Oswestry Disability Index is a commonly used scale for back pain subjects with a neuropathic pain component. The test is considered the 'gold standard' of low back functional outcome tools.
Patient Global Impression of Change (PGI-C) for Randomisation arm A
Time frame: up to 6 weeks
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Patient Global Impression of Change (PGI-C) for Randomisation arm B
Time frame: up to 6 weeks
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Patient Global Impression of Change (PGI-C) for Randomisation arm C
Time frame: up to 6 weeks
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Patient Global Impression of Change (PGI-C) for Randomisation arm D
Time frame: up to 6 weeks
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Patient Global Impression of Change (PGI-C)
Time frame: At 3 Months post randomisation
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
Patient Global Impression of Change (PGI-C)
Time frame: At 6 Months post randomisation
PGI-C is a standard seven-point scale (1-7) used to assess the SCS outcome. 1= No change, 2= Almost the same, 3=A little better, 4= Somewhat better, 5=Moderately better, 6=Better, 7= A great deal better.
EQ-5D 5 Level (EQ-5D-5L)
Time frame: Baseline
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm A
Time frame: up to 6 weeks
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm B
Time frame: Up to 6 weeks
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm C
Time frame: up to 6 weeks
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
EQ-5D 5 Level (EQ-5D-5L) for Randomisation arm D
Time frame: up to 6 weeks
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
EQ-5D 5 Level (EQ-5D-5L)
Time frame: At 3 months post- randomisation
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
EQ-5D 5 Level (EQ-5D-5L)
Time frame: At 6 months post- randomisation
EQ-5D-5L is comprised of a descriptive system and a visual analogue scale. The descriptive system measures quality of life along five dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five levels for each dimension from which subjects are asked to select one.
Pain and sleep index 3 (PSQ-3)
Time frame: Baseline
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain and sleep index 3 for Randomisation Arm A
Time frame: up to 6 weeks
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain and sleep index 3 for Randomisation Arm B
Time frame: up to 6 weeks
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain and sleep index 3 for Randomisation Arm C
Time frame: up to 6 weeks
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain and sleep index 3 for Randomisation Arm D
Time frame: up to 6 weeks
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain and sleep index 3
Time frame: At 3 months post randomisation
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain and sleep index 3
Time frame: At 6 months post randomisation
PSQ is an eight-item questionnaire developed to assess the impact of pain on quality of sleep. Seven of the eight items are scored using 100 mm VAS, while the remaining item asks individuals to indicate the average number of hours of sleep they get each night. Typically, the first five items on the scale are summed and used as an overall measure of the impact of pain on quality of sleep
Pain Drawing
Time frame: Baseline
Pain drawing will be used to help patients highlight all the body areas affected by neuropathic pain on a printed dermatome map. It will be collected at the baseline.
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm A
Time frame: up to 6 weeks
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm B
Time frame: up to 6 weeks
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm C
Time frame: up to 6 weeks
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Patient Satisfaction with Treatment (PSWT) for Randomisation Arm D
Time frame: up to 6 weeks
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Patient Satisfaction with Treatment (PSWT)
Time frame: At 3 months post randomisation
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Patient Satisfaction with Treatment (PSWT)
Time frame: At 6 months post randomisation
The Patient Satisfaction with Treatment survey will be used at the end of each Period and at end of study.
Electronic pain diary (e-diary)
Time frame: Up to 7 months
The patient will be asked to collect information about their pain daily with an e-Diary. A paper version of the diary will be included as a backup if the e-Diary malfunctions or the patient experiences difficulties with the e-Diary recordings.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 16528188Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain: challenges in treatment planning and present status, a 22-year experience. Neurosurgery. 2006 Mar;58(3):481-96; discussion 481-96. doi: 10.1227/01.NEU.0000192162.99567.96.
- Background: PubMed 28699301Owusu S, Huynh A, Gruenthal E, Prusik J, Owusu-Sarpong S, Cherala R, Peng S, Pilitsis JG, McCallum SE. Prospective Evaluation of Patient Usage of Above and Below Threshold Waveforms With Traditional Spinal Cord Stimulation Devices. Neuromodulation. 2017 Aug;20(6):567-574. doi: 10.1111/ner.12633. Epub 2017 Jul 11.
- Background: PubMed 26218762Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz High-frequency Therapy (HF10 Therapy) Is Superior to Traditional Low-frequency Spinal Cord Stimulation for the Treatment of Chronic Back and Leg Pain: The SENZA-RCT Randomized Controlled Trial. Anesthesiology. 2015 Oct;123(4):851-60. doi: 10.1097/ALN.0000000000000774.
- Individual participant dataSharing planned: No. This study will be registered with the Trust Information Governance Manager at Bart's Health NHS Trust, ensuring the confidentiality of personal data. A signed declaration form (data protection form) of the group to comply with the Data Protection Act and the Department of Health Code of Confidentiality will be applied.
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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.
Vivek Mehta 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?
An observational study of Neuropathic 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 10 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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?
Numerical Rating scale (time frame: Baseline- patient visit at start of the study). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04943770, which also lists 3 linked publications.
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.