Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome

Completed

• Conditions: Chronic Pain

• Registration Number: NCT03444168
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

The purpose of this study is to learn whether or not certain risk factors and patient characteristics are linked with and possibly can predict the development of chronic pain after lumbar spine surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-08
• Study First Submitted QC: 2018-02-21
• Study First Posted: 2018-02-23
• Study Start: 2018-06-29
• Primary Completion: 2023-04-20
• Study Completion: 2023-04-20
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pain severity	Change from Baseline to Month 6	Measured by the Brief Pain Inventory (BPI). The BPI scores are a numerical rating scale and range from 0 to 10. A score of 0 is equal to no pain and a score of 10 is equal to pain as bad as you can imagine.

Secondary Outcome Measures

Name	Time	Method
2011 Fibromyalgia Survey	Change from Baseline to Month 6	A measure of symptom severity in fibromyalgia. There is a total range of scores from 0 to 31. The higher the score the more severe a person's symptoms.
PROMIS (Patient-Reported Outcomes Measurement Information System)	Change from Baseline to Month 6	PROMIS measures to be included are Depression, Anxiety, Physical Functioning, Fatigue, Sleep Impairment, Emotional Support, and Social Participation. Each questionnaire usually has 4-16 response options ranging in value from one to five. The total raw score for a short form with all questions answered is the sum of the values of the response to each question. The total range of potential raw scores depends on the number of questions being asked, for example, a 6 item form would have a range from is 6 to 30. After the raw score is calculated, a T-score metric is used to convert the raw score to a T-score. On the T-score metric, a score of 50 is the mean of a relevant reference population and 10 is the standard deviation of that mean. For PROMIS measures, higher scores equals "more of the concept being measured", this could be a desirable or undesirable outcome, depending on the concept being measured.
Oswestry Disability Index	Change from Baseline to Month 6	The Oswestry Disability Index will be used to assess low back pain. There are 10 sections on the index. Each section has a possible score of 5. The total possible range of scores is 0 to 50. A score of 0 indicates no pain. A score of 50 indicates the person is bed-bound or exaggerating their symptoms.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States