A Prospective Trial to Assess the Safety and Performance of the Spinal Modulation Neurostimulator System in the Treatment of Chronic Pai

Active, not recruiting

• Conditions: Chronic Neuropathic Pain; Anaesthesiology - Pain management; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12610001062011
• Lead Sponsor: Spinal Modulation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-12-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Male or female >= 18 years old
2) Chronic, intractable pain in the thoracic, lumbar, and/or sacral distributions(s) for at least 6 months
3) Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy, and interventional pain procedures for chronic pain
4) Minimum baseline pain rating of 60 mm on the VAS
5) Stable pain medication dosage for at least 30 days
6) Stable neurologic function in the past 30 days

Exclusion Criteria

1) Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control
2) Escalating or changing pain condition within the past month as evidenced by investigator examination
3) Subject is currently involved in medically related litigation

4) Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump

5) Subject currently has an active infection
6) Subject has, in the opinion of the investigator, a medical comorbidity that contraindicates placement of an active medical device

7) Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation

8) Imaging (MRI, CT, x-ray) findings within the last 12 months that, in the investigator’s opinion, contraindicates lead placement

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Safety as determined by adverse event reporting. Adverse event profiles are expected to be similar to currently approved devices. These can include infection, lead migration, etc.[Multiple time points will be included in the follow-up. These timepoints include before and 1, 3, 6 and 12 months following implantation.];Device Performance as indicated by programmed outputs and the ability of the subject to control paresthesias.[Multiple time points will be included in the follow-up. These timepoints include before and 1, 3, 6 and 12 months following implantation.]

Secondary Outcome Measures

Name	Time	Method
Pain relief (VAS)[Baseline, 1, 3, 6 and 12 months];Quality of Life (EQ-5D)[Baseline, 1, 3, 6 and 12 months]