Quality of Life in Managing Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-16

Study Completion Date

2020-01-14

Brief Summary

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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.

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Detailed Description

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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 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.

Conditions

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Chronic Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Health-Related Quality of Life Report

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

Group Type EXPERIMENTAL

Health-Related Quality of Life Report

Intervention Type OTHER

Subject report and interpretation guide based on SPADE cluster scores

Wait List to Receive the Report

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Health-Related Quality of Life Report

Subject report and interpretation guide based on SPADE cluster scores

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Chronic Low Back Pain based on criteria established by the NIH Task Force on Research Standards for Chronic Low Back Pain AND SPADE Cluster Score ≥ 55