Evaluation of Spinal Cord Stimulation Pulse Rate On Clinical Outcomes (PROCO)

Evaluation of Stimulation Pulse Rate on Clinical Outcomes in Patients Whose Pain is Controlled by 10KHz Frequency - a Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Back Pain; Neuralgia
• Intervention / Treatment: Device: Boston Scientific PRECISION Spinal Cord Stimulator System

Detailed Description

This is a feasibility study to identify the optimal frequency for stimulation of the spinal cord to achieve maximum reduction in neuropathic back pain as measured by average Numerical rating Scale.

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Middlesbrough, United Kingdom, TS4 3BW
    • South Tees NHS Foundation Trust
  • Avon
    • Bristol, Avon, United Kingdom, BS10 5NB
      • North Bristol NHS Trust
  • Essex
    • Orsett, Essex, United Kingdom, RM16 3EU
      • Orsett Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Complaint of persistent or recurrent low back pain, with or without equal or lesser leg pain, for at least 90 days prior to Screen.
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:

1. Average worst leg pain intensity is greater than average worst low back pain intensity as reported during Baseline period based on eDiary.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1; Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to A KHz	Device: Boston Scientific PRECISION Spinal Cord Stimulator System; Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
Active Comparator: Arm 2; Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to B KHz	Device: Boston Scientific PRECISION Spinal Cord Stimulator System; Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
Active Comparator: Arm 3; Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to C KHz	Device: Boston Scientific PRECISION Spinal Cord Stimulator System; Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
Active Comparator: Arm 4; Boston Scientific PRECISION Spinal Cord Stimulator System with MultiWave Technology programmed to D KHz	Device: Boston Scientific PRECISION Spinal Cord Stimulator System; Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain relief	Mean reported pain on Numerical Rating Scale (NRS)	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Leg pain relief	Mean reported pain on Numerical Rating Scale (NRS)	3-6 months
Patient global impression of change at end of Long-Term Follow-up	Questionnaire	6-9 months
Change in quality of life (EQ-5D) from Baseline Visit to end of Long-Term Follow-up	Questionnaire	6-9 months
Change in activities of Daily Living related to back pain disability from Baseline visit to end of Long-Term Follow-up	Questionnaire	6-9 months

Collaborators and Investigators

• Sponsor: Mid and South Essex NHS Foundation Trust
• Collaborators: North Bristol NHS Trust
• Investigators: Study Chair: Simon Thomson, MD, National Health Service, United Kingdom

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 13, 2017
• Study Completion (Actual): July 13, 2017

Study Registration Dates

• First Submitted: September 1, 2015
• First Submitted That Met QC Criteria: September 14, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Spinal Cord Stimulation
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia
• Other Study ID Numbers: B726

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No