NCT04168437

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
331

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

November 26, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

November 15, 2019

Last Update Submit

May 18, 2022

Conditions

Chronic Low Back Pain

Keywords

Back PainQuality of LifePROMIS-29PRECISION Pain Research Registry

Outcome Measures

Primary Outcomes (1)

  • PROMIS-29 Quality of Life Measures

    SPADE Cluster Scores (population mean, 50)

    3 Months Post-Randomization

Secondary Outcomes (2)

  • Low Back Pain Intensity

    3 Months Post-Randomization

  • Back-Related Disability

    3 Months Post-Randomization

Study Arms (2)

Health-Related Quality of Life Report

EXPERIMENTAL

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

Other: Health-Related Quality of Life Report

Wait List to Receive the Report

NO INTERVENTION

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

Interventions

Health-Related Quality of Life ReportOTHER

Two page report and interpretation guide based on SPADE cluster scores

Health-Related Quality of Life Report

Eligibility Criteria

Age21 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Low Back Pain AND SPADE Cluster Score ≥ 55

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John C Licciardone, DO, MS, MBA

    University of North Texas Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2019

First Posted

November 19, 2019

Study Start

November 26, 2019

Primary Completion

August 31, 2021

Study Completion

October 31, 2021

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)