A study investigating movement, pain and activity in failed back surgery patients undergoing spinal cord stimulation.

Not Applicable

Recruiting

• Conditions: Failed Back Surgery Syndrome; Lower back pain; Leg pain; Musculoskeletal - Other muscular and skeletal disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12615001038583
• Lead Sponsor: Dr Richard Sullivan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

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

Inclusion Criteria

1.Males and Females aged over 18
2.FBSS, defined as persistent or re-current low back and leg pain of at least 6 months duration, following at least one decompression and/or fusion procedure
3.Deemed as clinically appropriate for a trial of spinal cord stimulation for the treatment of FBSS
4.Minimum average pain level measured on a numerical rating scale of at least 3
5.Activity limitation as recorded by the Oswestry disability index of > 20%
6.Pain that changes with position or movement
7.Ability to understand and willingness to sign an informed consent statement in English

Exclusion Criteria

1.Lower back surgery within previous six months.
2.The subject is being currently treated or has been treated with SCS, subcutaneous or peripheral nerve stimulation, intrathecal drug delivery system, or is awaiting further lumbar surgery.
3.Is pregnant or planning to become pregnant during the course of the study;
4.Subjects with a severe hearing impairment or inability to follow verbal instructions.
5.Evidence of non-mechanical contributing cause for lower back pain e.g. neoplasm, infection, fracture, inflammatory disorder or persistent non-fluctuating pain.
6.Implanted electrical medical device that would conflict with either the spinal cord stimulator implant or the measurement technology
7.Significant medical or psychological abnormalities/conditions, a history of substance abuse or recent history of a medical-surgical intervention that in the opinion of the investigator would interfere either with the ability to complete the study or the assessments.
8.Known allergy skin reaction to tapes and plasters.
9.Subject who is currently enrolled in an investigational drug or device study
10.Inability to operate the SCS equipment, comply with study requirements or complete questionnaires in English independently.

Study & Design

• Study Type: Interventional
• Study Design: Not specified