Multi-Center, Prospective Clinical Trial of the Senza Spinal Cord Stimulation (SCS) System in the Treatment of Chronic Upper Limb and Neck Pai

Not Applicable

Completed

• Conditions: Chronic Upper Limb and/or Neck Pain; Anaesthesiology - Pain management

• Registration Number: ACTRN12614000153617
• Lead Sponsor: evro Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-10
• Study Completion: 2017-12-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

1. Have been diagnosed with chronic, intractable pain of the upper limb and/or neck related to the cervical spine and/or neuropathic arm pain.

2. Considering daily activity and rest, have average upper limb or neck pain intensity of greater than or equal to 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment.

3. Be an appropriate candidate for HF10 SCS.

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 assessments , accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis and
fibromyalgia).

2. Have evidence of 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, as determined by a psychologist.

3. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, central deafferentation syndrome, Complex Regional Pain Syndrome, acute herniating disc, severe cervical spinal stenosis and brachial plexus injury as determined by the investigator.

4. Having pain in the shoulder girdle or arm with a primary etiology due to a shoulder pathology.

5. Have a current diagnosis of a coagulation disorder, bleeding diathesis that would put patient at any increased risk of bleeding during SCS procedure, progressive peripheral vascular disease or uncontrolled diabetes mellitus.

6. Having any clinical evidence mechanical instability or progressive neurologic pathology that warrants surgical intervention. Neurologic pathology related to severe or critical cervical spondylosis including spinal stenosis (AP diameter <10 mm), myelomalacia not related to a previously corrected stenosis, radiculopathy manifest clinically by motor deficit in setting of anatomic etiology (herniated nucleus pulposis).

7. Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) that would disrupt/obliterate the posterior epidural space.

Study & Design

• Study Type: Interventional
• Study Design: Not specified