Validation of positional data in the Intellis implantable neurostimulator in patients with neuropathic pain.

Not Applicable

Withdrawn

• Conditions: ower back pain; Leg pain; Neuropathic pain; Lower back pain; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12619000733178
• Lead Sponsor: Precision Health Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-16
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1.adult patients (18 to 70 years of age)
2.diagnosed with chronic intractable pain of the lower back and/or leg (s)
3.have passed a neuropsychological screen as per standard of care for SCS
4.have opted to undergo permanent SCS implant
5.able to move freely between sitting, standing, lying and walking positions unassisted
6.be willing and capable of giving informed consent
7.be willing and able to comply with study-related requirement, procedures and visits
8.females of childbearing age must have a negative urine pregnancy test at baseline (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)

Exclusion Criteria

1.have a medical condition or pain in other area (s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
2.have evidence of an active, disruptive psychological or psychiatric disorder or other known condition significant enough to impact mobility, severe sleep disturbance, compliance of intervention and/or ability to evaluate treatment outcomes
3.have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
4.have a condition currently requiring or likely to require the use of MRI or diathermy
5.have been diagnosed with a malignancy or has an active systemic infection
6.be pregnant or nursing
7.have within 6 months of enrolment a significant untreated addiction to dependency producing medications or have been a substance abuser
8.are under active worker’s compensation (or personal injury) litigation or adjudication

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint will be comparison of Intellis positional data against Vital Patch and manual entry during the controlled testing phase. The positional data variable being evaluated are: walking, sitting, standing, lying (supine, prone, left side, right side)[Visit 3 - 28-42 days post permanent SCS implant surgery]

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint will be comparison of Intellis positional data against Vital Patch and ADL Diary during activity of daily living phase. The positional data variable being evaluated are: walking, sitting, standing, lying (supine, prone, left side, right side)[Conclusion of 5 days VitalPatch wear]