Evaluating the Effect of Spinal Cord Stimulation Frequency on Fast-Acting Sub-perception Therapy (FAST) for Chronic Pain

NCT04943770 | Withdrawn FDA Device

• 1 other identifier: 281237
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Neuropathic Low Back Pain

Keywords

spinal cord stimulation; sub-perception; low back pain; wash in/wash out; neuropathic pain

Outcome Measures

Primary Outcomes (42)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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

  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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Up to 7 months

Study Arms (1)

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.

Procedure: Spinal cord stimulator implant; Diagnostic Test: Healing period; Device: WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system

Interventions

Spinal cord stimulator implant PROCEDURE

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.

Also known as: Boston Scientific Wavewriter

WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system

Healing period DIAGNOSTIC_TEST

Acute opioid pain medications may be continued. No additional scheduled assessments will be completed during this period.

WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system

WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system DEVICE

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.

WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Barts Health NHS Trust

London, EC1A 4NP, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 16528188 BACKGROUND

• Owusu 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.

  PMID: 28699301 BACKGROUND

• Kapural 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.

  PMID: 26218762 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Neuralgia

Interventions

Spinal Cord Stimulation; Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Drug Therapy

Study Officials

• Vivek Mehta

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: June 29, 2021
• Study Start: October 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)