Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures

NCT ID: NCT04168437

Last Updated: 2022-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 331 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-26
• Study Completion Date: 2021-10-31

Brief Summary

This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Half of the participants will receive the report, while the other half will not.

Detailed Description

The health-related quality of life report provides participants with an overall score on the SPADE cluster and scores on each of its five component scales. The recently released Federal Pain Research Strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life. It recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life. Further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome. This study primarily aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain. Another aspect of the study will be to determine how the health-related quality of life report may impact the physician-patient interaction. This will be assessed using validated measures of physician interpersonal manner, empathy, and communication style, as well as end-of-trial survey data acquired from participants assigned to the experimental group. The survey will include an overall assessment of the report, as well as specific actions attributed to the report.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Health-Related Quality of Life Report

Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report.

Group Type: EXPERIMENTAL

Health-Related Quality of Life Report

Intervention Type: OTHER

Two page report and interpretation guide based on SPADE cluster scores

Wait List to Receive the Report

Participants randomized to this arm will receive the 2- page Health-Related Quality of Life Report following completion of the study.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Health-Related Quality of Life Report

Two page report and interpretation guide based on SPADE cluster scores

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Chronic Low Back Pain AND SPADE Cluster Score ≥ 55

Exclusion Criteria

• Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Texas Health Science Center

OTHER

Sponsor Role: lead

Responsible Party

John C. Licciardone, D.O., M.S., M.B.A.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John C Licciardone, DO, MS, MBA

Role: PRINCIPAL_INVESTIGATOR

University of North Texas Health Science Center

Locations

University of North Texas Health Science Center

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

2015-169

Identifier Type: -

Identifier Source: org_study_id