Evaluation of Spinal Cord Stimulation Pulse Rate On Clinical Outcomes

NCT02549183 | Completed

• 1 other identifier: B726
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

Brief Summary

Clinical study to estimate the optimal frequency for stimulation of the spinal cord to achieve relief from back pain.

Conditions

Back Pain; Neuralgia

Keywords

Spinal Cord Stimulation

Outcome Measures

Primary Outcomes (1)

• Back pain relief

  Mean reported pain on Numerical Rating Scale (NRS)

  Three months

Secondary Outcomes (4)

• Leg pain relief

  3-6 months

• Patient global impression of change at end of Long-Term Follow-up

  6-9 months

• Change in quality of life (EQ-5D) from Baseline Visit to end of Long-Term Follow-up

  6-9 months

• Change in activities of Daily Living related to back pain disability from Baseline visit to end of Long-Term Follow-up

  6-9 months

Study Arms (4)

Arm 1

ACTIVE COMPARATOR

Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to A KHz

Device: Boston Scientific PRECISION Spinal Cord Stimulator System

Arm 2

ACTIVE COMPARATOR

Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to B KHz

Device: Boston Scientific PRECISION Spinal Cord Stimulator System

Arm 3

ACTIVE COMPARATOR

Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to C KHz

Device: Boston Scientific PRECISION Spinal Cord Stimulator System

Arm 4

ACTIVE COMPARATOR

Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to D KHz

Device: Boston Scientific PRECISION Spinal Cord Stimulator System

Interventions

Boston Scientific PRECISION Spinal Cord Stimulator System DEVICE

Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.

Arm 1; Arm 2; Arm 3; Arm 4

Eligibility Criteria

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

You may qualify if:

• 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.)
• 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).
• years of age or older when written informed consent is obtained.
• 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.
• Baseline Oswestry Disability Index score ≥ 20 and ≤ 80.
• Received at least 30 per cent reduction in NRS of average low back pain intensity from Baseline during the end of Post Implant HF10 Sweet-Spot Search as recorded in the eDiary.

You may not qualify if:

• Average worst leg pain intensity is greater than average worst low back pain intensity as reported during Baseline period based on eDiary.
• Radiographic evidence of spinal instability requiring fusion.
• 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.
• 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.
• Participating (or intends to participate) in another clinical study.
• Terminal illness with anticipated survival 1 year.
• Current condition associated with risk of immunocompromised that might increase risk of infection during study duration.
• Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
• Are pregnant/lactating or not using adequate birth control.
• Have untreated major psychiatric comorbidity, serious drug related behaviour issues.

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• North Bristol NHS Trust: collaborator

Study Sites (3)

North Bristol NHS Trust

Bristol, Avon, BS10 5NB, United Kingdom

Location

Orsett Hospital

Orsett, Essex, RM16 3EU, United Kingdom

Location

South Tees NHS Foundation Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Related Publications (1)

• Thomson SJ, Tavakkolizadeh M, Love-Jones S, Patel NK, Gu JW, Bains A, Doan Q, Moffitt M. Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial. Neuromodulation. 2018 Jan;21(1):67-76. doi: 10.1111/ner.12746. Epub 2017 Dec 8.

  PMID: 29220121 RESULT

MeSH Terms

Conditions

Back Pain; Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Simon Thomson, MD

  National Health Service, United Kingdom

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2015
• First Posted: September 15, 2015
• Study Start: June 1, 2015
• Primary Completion: July 13, 2017
• Study Completion: July 13, 2017
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)