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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)

Primary Purpose

Palliative Care

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Senza Spinal Cord Stimulation system

About this trial

This is an interventional supportive care trial for Palliative Care

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Leeds Teaching Hospitals NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients to receive spinal cord stimulator

Arm Description

Outcomes

Primary Outcome Measures

50% reduction in patient reported Visual analogue scale for pain

50% reduction in patient reported numerical rating score for pain

Secondary Outcome Measures

Full Information

NCT ID

NCT02689375

First Posted

February 11, 2015

Last Updated

January 11, 2019

Sponsor

The Leeds Teaching Hospitals NHS Trust

1. Study Identification

Unique Protocol Identification Number

NCT02689375

Brief Title

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

Acronym

Maiden Back

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

September 18, 2014 (Actual)

Primary Completion Date

October 18, 2017 (Actual)

Study Completion Date

October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Leeds Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Palliative Care

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients to receive spinal cord stimulator

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Senza Spinal Cord Stimulation system

Intervention Description

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

Primary Outcome Measure Information:

Title

50% reduction in patient reported Visual analogue scale for pain

Time Frame

12 months compared to baseline

Title

50% reduction in patient reported numerical rating score for pain

Time Frame

12 months compared to baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Leeds Teaching Hospitals NHS Trust

City

Leeds

State/Province

West Yorkshire

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

12. IPD Sharing Statement

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