Quality of Life Outcomes in Spinal Cord Stimulation

Low Back Pain Clinical Trial

Official title:

A Prospective Analysis of Quality of Life Outcomes in Spinal Cord Stimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03249922
• Other study ID #: Pro20170000766
• Status: Terminated
• Start date: October 27, 2017
• Est. completion date: July 22, 2018

Study information

• Verified date: July 2018
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will be evaluating quality of life outcomes in patients who are undergoing routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre and post-operatively for quality of life improvements, pain control, and functionality.

Description:

This is a prospective cohort study for patients who will be undergoing implantation of spinal cord stimulator for pain. All patient will have implantation done at University Hospital Newark or Newark Beth Israel. The data points that will be collected will be the patient's weight, BMI, and detailed questionnaires regarding disability, activity, quality of life, and depression. The first data set will be taken pre-operatively at the DOC, 90 Bergen Street, suite 8100. Those patients enrolled will have the same data taken again upon subsequent postoperative visits at 3, 6, and 12 months. Being that spinal cord stimulation is a well-documented safe procedure, the investigators do not anticipate any deviation from the standard risks of surgery. With that being said the primary safety endpoint would be if there is an increased complication rate, secondary to the procedure, greater than the current anticipated risk rate. This is a purely observational study. Patients are not being recruited for an intervention but are being recruited during routine clinical practice.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: July 22, 2018
• Est. primary completion date: July 22, 2018
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with neuropathic pain or axial back pain that is not controlled by oral analgesics, opioids, and has failed conservative management.

• Ages 18-90 with no ethnicity or gender predilections.

Exclusion Criteria:

• Patients who have spinal cord injury, multiple stimulator revisions, DRG stimulators, intrathecal pain pumps, complex regional pain syndrome, previous spinal cord stimulator implant, mechanical instability requiring fusion, myelopathy, psychological condition precluding them from complying with therapy, illegal drug abuse including heroin, cocaine, and illegally obtained prescription pills, or have previously been or are currently involved in litigation for medical malpractice.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Spinal Cord Stimulation
Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.

Locations

Country	Name	City	State
United States	Neurologic Institute of New Jersey	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Total number of surgical and post-operative Complications	Total number of surgical and post-operative complications occurring during the study	12 months
Primary	The number of patients with at least 50% improvement in VAS Pain Score	The number of patients who had at least 50% improvement in VAS pain score	12 Months
Primary	The number of patients with at least 50% improvement in Owenstry low back disability index	The number of patients who had at least 50% improvement in disability as determined by this questionnaire.	12 Months
Primary	The number of patients with at least 50% improvement in WHODAS 12 disability index.	The number of patients who had at least 50% improvement in disability as determined by this questionnaire.	12 Months
Secondary	The number of patients with at least 50% improvement in SF-36 quality of life score	The number of patients who had at least 50% improvement in quality of life as determined by this questionnaire.	12 months
Secondary	The number of patients with at least 50% improvement in beck depression inventory	The number of patients who had at least 50% improvement in depression as determined by this questionnaire.	12 Months