Sham-Controlled RCT on 10kHz High-Frequency Spinal Cord Stimulation for Chronic Neuropathic Low Back Pain (Modulate-LBP)

NCT03470766 | Terminated DMC FDA Device

• 1 other identifier: Modulate-LBP
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.

Conditions

Chronic Low Back Pain; Neuropathic Pain; Refractory Pain

Keywords

Neuromodulation; HF10; HF-10; Nevro; High-frequency; 10kHz; Spinal Cord Stimulation; CNLBP; Chronic Neuropathic Low Back Pain; Double blind randomised sham-controlled; PANARC; SCS

Outcome Measures

Primary Outcomes (1)

• Mean VAS Back Pain (7 Day Subject VAS Pain Diary)

  Changes in mean VAS back pain between intervention and control at 6 months post-randomisation

  6 months post randomisation

Secondary Outcomes (9)

• Oswestry disability index (v2.1a)

  1, 3, and 6 months post randomisation

• PHQ-9 Questionnaire

  1, 3, and 6 months post randomisation

• PSQI Questionnaire

  1, 3, and 6 months post randomisation

• PGIC Questionnaire

  1, 3, and 6 months post randomisation

• EQ-5D Questionnaire

  1, 3, and 6 months post randomisation

Study Arms (2)

Active Lead (AL)

ACTIVE COMPARATOR

One octad lead placed where contacts 4 and 5 span the T9-T10 disc space.

Device: Nevro Senza System (HF10 Therapy)

Sham Lead (SL)

SHAM COMPARATOR

One octad lead implanted subcutaneously behind the IPG and will serve to dissipate the current from the battery

Device: Nevro Senza System (HF10 Therapy)

Interventions

Nevro Senza System (HF10 Therapy) DEVICE

Nevro 10kHz High Frequency Spinal Cord Stimulation

Also known as: Neuromodulation, High-frequency stimulation, Nevro, HF-10, HF10, SCS, 10kHz SCS

Active Lead (AL); Sham Lead (SL)

Eligibility Criteria

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

You may qualify if:

• Adults over the age of 18
• Onset of low back pain \> 12 months
• Low back pain intensity \> 60 out of 100mm on pain visual analogue scale (VAS)
• Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography
• On stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and not change medication dosage without consulting Investigator
• Legally able to provide informed consent
• Able to comply with study-related requirements, procedures and visits

You may not qualify if:

• Had previous spinal surgery
• Chronic widespread pain
• Subject has an active implanted device, whether turned on or off (e.g. pacemaker, intrathecal pump, deep brain stimulator etc.)
• A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumour, or severe/critical central or foraminal spinal stenosis
• Mechanical spine instability detected by a clinician (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by \>5 degrees segmental angular movement) e.g. any forms of spondylolisthesis
• A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
• Bleeding diathesis such as coagulopathy or thrombocytopenia
• Immunocompromised and at an increased risk for infection
• Systemic infection or local infection that would contraindicate SCS placement
• Metastatic malignant disease or active local malignant disease
• Pregnant (if female and sexually active, subject must be using a reliable form of contraception, be surgically sterile or be at least 2 years post-menopausal)
• Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication.
• Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
• Concomitant participation in another clinical trial (surgery, device or drug)

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Pain And Neuromodulation Academic Research Centre (PANARC): collaborator
• University of Exeter: collaborator
• National Institute for Health Research, United Kingdom: collaborator
• King's College London: collaborator
• University of Oxford: collaborator
• University of Liverpool: collaborator
• James Cook University Hospital: collaborator

Study Sites (2)

Guy's and St Thomas Hospital

London, SE1 7EH, United Kingdom

Location

South Tees Hospitals NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Related Publications (2)

• O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

  PMID: 34854473 DERIVED

• Al-Kaisy A, Royds J, Palmisani S, Pang D, Wesley S, Taylor RS, Cook A, Eldabe S, McCracken L, Duarte R, Fairbank J. Multicentre, double-blind, randomised, sham-controlled trial of 10 khz high-frequency spinal cord stimulation for chronic neuropathic low back pain (MODULATE-LBP): a trial protocol. Trials. 2020 Jan 28;21(1):111. doi: 10.1186/s13063-019-3831-4.

  PMID: 31992344 DERIVED

MeSH Terms

Conditions

Neuralgia; Pain, Intractable

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind. Implanter is blinded, research staff are blinded, subject is blinded. One unblinded research personnel at each recruiting site programming the patients at device activation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, randomised, double-blinded, sham-controlled trial with parallel economic evaluation. Patients will be allocated 1:1 to activated 10kHz SCS plus usual care (intervention) or sham 10kHz SCS plus usual care (control) and followed up to 6 months.

Study Record Dates

• First Submitted: March 13, 2018
• First Posted: March 20, 2018
• Study Start: August 14, 2018
• Primary Completion: October 20, 2022
• Study Completion: October 20, 2022
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)