Evaluation of Spinal Cord Stimulation Pulse Rate On Clinical Outcomes
NCT ID: NCT02549183
Last Updated: 2020-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2015-06-01
2017-07-13
Brief Summary
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Detailed Description
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Twenty patients who suffer from back more than leg pain will be recruited into the study once they have satisfactory pain relief from both low and high frequency stimulations. Each patient will then receive stimulation at four different frequencies for 2-3 weeks in a random and blinded order. Their pain scores and function will be assessed using a variety of different tools. The data will then be used to estimate the optimal frequency.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Arm 1
Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to A KHz
Boston Scientific PRECISION Spinal Cord Stimulator System
Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
Arm 2
Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to B KHz
Boston Scientific PRECISION Spinal Cord Stimulator System
Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
Arm 3
Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to C KHz
Boston Scientific PRECISION Spinal Cord Stimulator System
Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
Arm 4
Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to D KHz
Boston Scientific PRECISION Spinal Cord Stimulator System
Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
Interventions
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Boston Scientific PRECISION Spinal Cord Stimulator System
Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
Eligibility Criteria
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Inclusion Criteria
2. Received at least 90 days of documented pain management care to address the primary pain complaint, prior to Screening (e.g. medication, physical therapy.)
3. No back surgery within 6 months prior to Screening.
4. 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.
5. 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
6. 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).
7. 18 years of age or older when written informed consent is obtained.
8. If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test at Screening.
9. Subject signed a valid, IRB-approved informed consent form (ICF) provided in English.
10. Baseline Oswestry Disability Index score ≥ 20 and ≤ 80.
11. 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.
Exclusion Criteria
2. Radiographic evidence of spinal instability requiring fusion.
3. Primary pain complaint of vascular origin (e.g. peripheral vascular disease).
4. Spinal pain secondary to neoplasm, infection, autoimmune disorder with spinal involvement, or a spinal metabolic disorder.
5. 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.
6. Participating (or intends to participate) in another clinical study.
7. Terminal illness with anticipated survival 1 year.
8. Current condition associated with risk of immunocompromised that might increase risk of infection during study duration.
9. Currently on any anticoagulant medications that cannot be discontinued during perioperative period.
10. Are pregnant/lactating or not using adequate birth control.
11. Have untreated major psychiatric comorbidity, serious drug related behaviour issues.
18 Years
ALL
No
Sponsors
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North Bristol NHS Trust
OTHER
Mid and South Essex NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Simon Thomson, MD
Role: STUDY_CHAIR
National Health Service, United Kingdom
Locations
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North Bristol NHS Trust
Bristol, Avon, United Kingdom
Orsett Hospital
Orsett, Essex, United Kingdom
South Tees NHS Foundation Trust
Middlesbrough, , United Kingdom
Countries
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References
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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.
Other Identifiers
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B726
Identifier Type: -
Identifier Source: org_study_id