A clinical study to evaluate HF10 therapy using surgical leads

Not Applicable

• Conditions: Chronic, intractable, back and/or leg pain of neuropathic origin; Signs and Symptoms; Chronic intractable pain

• Registration Number: ISRCTN10619673
• Lead Sponsor: evro Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-22
• Last Update Posted: 11 November 2019
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

1. Have chronic intractable back pain and/or leg pain of neuropathic origin, as determined by the physician
2. An appropriate candidate for spinal cord stimulation and/or surgical lead placement as determined by the physician
3. Already scheduled for either a commercial trial with Nevro or a permanent implant of the Senza system (with surgical lead only)
4. Be 18 years of age or older at the time of enrollment
5. Be able to read and understand the Patient Informed Consent Form
6. Be willing and capable of giving informed consent

Exclusion Criteria

1. Contraindicated for surgical lead placement and/or spinal cord stimulation; physician should reference labeling for precautions, warnings and indications

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Responder rate at 3 months (a responder is defined as a subject who experiences =30% pain reduction compared to baseline as assessed by NRS & improvement in health status per the patient global impression of change questionnaire)

Secondary Outcome Measures

Name	Time	Method
<br> 1. Pain is measured using the numerical rating scale (NRS) at baseline, end of trial, 3, 6 and 12 months<br> 2. Disability is measured using the Oswestry Disability Index (ODI) at baseline, 3, 6 and 12 months<br> 3. Quality of life is measured using the EQ-5D-5L at baseline, 3, 6 and 12 months<br> 4. Opioid intake is measured using a medication log at baseline, end of trial, 3, 6, 12 months<br> 5. Health status is measured using the patient/physician global impression of change questionnaire at end of trial, 3, 6, 12 months<br> 6. Participant satisfaction with the therapy is measured using the subject satisfaction questionnaire at 3,6 and 12 months<br>