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

December 21, 2020 updated by: Mid and South Essex NHS Foundation Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Back pain relief
Time Frame: Three months
Mean reported pain on Numerical Rating Scale (NRS)
Three months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Leg pain relief
Time Frame: 3-6 months
Mean reported pain on Numerical Rating Scale (NRS)
3-6 months
Patient global impression of change at end of Long-Term Follow-up
Time Frame: 6-9 months
Questionnaire
6-9 months
Change in quality of life (EQ-5D) from Baseline Visit to end of Long-Term Follow-up
Time Frame: 6-9 months
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
Time Frame: 6-9 months
Questionnaire
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mid and South Essex NHS Foundation Trust

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
North Bristol NHS Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Simon Thomson, MD, National Health Service, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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