A Prospective, Open Label, Pilot Study of Patient OutcoMes Following Successful TriAl of High Frequency SpInal CorD Stimulation at 10kHz (HF10™) Leading to Permanent Implant Compared to Trial Failure and Standard CarE for the TreatmeNt of Persistent Low BACK Pain of Neuropathic Origin (Maiden Back)

January 11, 2019 updated by: The Leeds Teaching Hospitals NHS Trust

Rospective, Open Label, Pilot Study of Patient OutcoMes Following Successful TriAl of High Frequency SpInal CorD Stimulation at 10kHz (HF10™) Leading to Permanent Implant Compared to Trial Failure and Standard CarE for the TreatmeNt of Persistent Low BACK Pain of Neuropathic Origin

25 participants with back pain and no previous spinal surgery will be enrolled from a single NHS site in England.

Participants will have already discussed spinal cord stimulation (SCS) pain management with their consultant before being invited to participate. Participants will attend for 10 visits over a period of 66 months. At visit one, study suitability screening and informed consent will be conducted. Suitable participants will be booked to have SCS trial leads implanted and an external programmable High Frequency battery trial box as a day case (Visit 2). Participants will be contacted over the next 21 days to assess how the trial is progressing and to book a follow up appointment in clinic to remove the trial leads (Visit 3) where a treatment decision will be made. If a participant is determined as having had a successful trial they will be listed and implanted with a full HF10 SCS implant (Visit 4). The participants who proceed to a full HF10 SCS implant will be reviewed in the Clinic at 6, 12, 24, 36, 48 and 60 months post procedure. Their participation in this study will be no longer than 66 months. A successful trial is defined as a reduction in pain by 30% on a Visual Analogue Scale. Participants who do not obtain 30% reduction in 21 days is classed as a failed trial and once the leads are removed will be reviewed in clinic by the investigator for an alternative treatment plan (Visit 4). If a participant is determined a failed trial of HF10, they will remain in the study with their consent for the full follow up schedule. The follow-up for the failed trial cohort can be conducted via telephone to reduce the burden on this trial group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • 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
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Leeds Teaching Hospitals NHS Trust

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

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

I. Patient is 18 years of age or older and has given written informed consent. II. Has persistent chronic predominant low back pain of neuropathic origin, with or with out radiculopathy, for a minimum of 6 months III. Visual Analogue Scale (VAS) back pain score of at least 50 mm at baseline IV. Confirmation of pain from neuropathic origin by SLANSS score (≥12) AND PainDETECT score( ≥19) V. Total daily dose of opioids equivalent to ≤200mg of Morphine VI. No previous open spinal surgery (percutaneous procedures such as nucleoplasty are not considered as open surgical procedures) VII. Failed conservative therapies such as physiotherapy, chiropractor, hydrotherapy, TENS.

VIII. MRI within the previous 18 months (as per standard care) IX. In the investigators opinion the patient is a suitable candidate for HF10

Exclusion Criteria:

I. Patient has mechanical spine instability based on flexion/extension testing of lumbar spine (documented in the last 6 months) II. Patient is pregnant, or pregnancy is suspected or planned within the first six months of the study timeframe.

III. Patient has a cardiac pacemaker, automatic defibrillator, or any other implanted device, which will make the trial impossible. IV. Allergy to device components or drugs to be used in the intended procedure. V. Medical co-morbidities that preclude surgical intervention. VI. Patient is incapable of understanding or responding to the study questionnaires VII. Patient is incapable of understanding or operating the patient programmer handset.

VIII. History of previous open spinal surgery (not percutaneous procedures) IX. Patient is morbidly obese (BMI ≥ 40). X. Patient is simultaneously participating in another device or drug study within the last 30 days.

XI. Patient has a spinal fracture, tumour or infection. XII. Clinical evidence of cauda equina syndrome. XIII. Progressive neurologic deficit.

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients to receive spinal cord stimulator
Device: Senza Spinal Cord Stimulation system
Suitable participants will be booked to have spinal cord stimulator trial leads implanted and an external programmable High Frequency battery trial box as a day case

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
50% reduction in patient reported Visual analogue scale for pain
Time Frame: 12 months compared to baseline
12 months compared to baseline
50% reduction in patient reported numerical rating score for pain
Time Frame: 12 months compared to baseline
12 months compared to baseline

Collaborators and Investigators

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

Sponsor

The Leeds Teaching Hospitals NHS Trust

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)

September 18, 2014

Primary Completion (Actual)

October 18, 2017

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

February 11, 2015

First Submitted That Met QC Criteria

February 18, 2016

First Posted (Estimate)

February 23, 2016

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 11, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM13/10904

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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