Single-Arm, Multicenter Study to Evaluate Safety and Efficacy of Low Frequency Spinal Cord Stimulator in Subjects with Low Back and/or Leg Pai

Not Applicable

Completed

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

• Registration Number: ACTRN12619001252101
• Lead Sponsor: Presidio Medical AU, Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-11
• Study Completion: 2020-01-29
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

literate, able to speak English and able to complete questionnaires independently.
- Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol.
- have been diagnosed with chronic, intractable pain of the low back and/or legs (VAS greater than or equal to 60mm for the past week) which has been refractory to conservative therapy for a minimum of 3 months.
- Are currently receiving optimal medical management and considered medically stable as judged by the investigator.
- Able to change AA batteries and operate the EPG.

Exclusion Criteria

1 If female and sexually active, subject must be using a reliable form of birth
control, be surgically sterile or be at least two years post-menopausal
2. IV Contrast allergy
3. Severe cognitive impairment as determined by investigator
4. A psychological assessment will be performed at Baseline to exclude an
active disruptive psychological or psychiatric disorder or other known
condition significant enough to impact perception of pain, compliance of
intervention and/or ability to evaluate treatment outcome. This will be
performed by the investigator in consultation with a clinical psychologist if
applicable
5. Pre-existing motor, balance, proprioception, or sensory deficits as determined
by investigator
6. Spinal Stenosis or other structural spinal abnormality observed on MRI that
would make lead placement unsafe or untowardly difficult as determined by
investigator
7. Currently taking anticoagulants including Warfarin, Heparin, Low Molecular
Weight Heparin, Factor Xa inhibitors, GPIIb/IIIa inhibitors, thienopyridine
inhibitors, direct thrombin inhibitors, or any other anticoagulant that is a
contraindication to epidural lead placement within 1 week of the Screening
Visit
8. Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by
clinical history and, if clinically indicated, by coagulation screening)
9. Cardiac demand pacemaker, implanted defibrillator or other implanted
electronic device
10. A systemic condition or disease not stabilized or judged by the investigator to
be incompatible with participation in the study (e.g. current systemic infection,
uncontrolled autoimmune disease, uncontrolled immunodeficiency disease,
history of myocardial infarction, etc.)
11. Known hypersensitivity to any of the procedural agents or materials in the
study device that is inserted into the subject
12. Previous non-responder to spinal cord stimulation

Study & Design

• Study Type: Interventional
• Study Design: Not specified