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Behavioral Intervention for Chronic Lower Back Pain

N/A

Waitlist Available

Led By Una Makris, MD

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported low back pain (+/-radiation) in the past 3 months that interferes with daily activities on most days

Aged 50 and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 6 months

Awards & highlights

Study Summary

This trial will assess the feasibility of a tele-based intervention for older adults with chronic low back pain and depression.

Who is the study for?

The MOTIVATE trial is for English-speaking adults aged 50 or older who have chronic lower back pain with an intensity of at least 4 out of 10, experience daily activity interference due to back pain, and also suffer from depression. Participants must be able to engage in home-based activities and have a working telephone.Check my eligibility

What is being tested?

This study tests a tele-based behavioral change intervention for reducing disability and depressive symptoms related to chronic low back pain in older adults. A health coach will deliver the program using motivational interviewing techniques over the phone.See study design

What are the potential side effects?

Since this is a behavioral intervention involving motivational interviewing and not medication, there are no direct medical side effects. However, participants may experience emotional discomfort or fatigue during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had lower back pain that affects my daily activities for the past 3 months.

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I am 50 years old or older.

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I have chronic low back pain rated 4 or higher out of 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of intervention completion

Recruitment rates

Secondary outcome measures

Depression

Pain scale

Roland Morris Disability Questionnaire (RMDQ)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Behavioral Intervention GroupExperimental Treatment1 Intervention

For participants assigned to the intervention arm, trained health coaches will deliver the intervention via telephone. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant.

Group II: Waitlist Control GroupActive Control1 Intervention

The waitlist control group will continue with management of chronic back pain and depression per usual care. All participants, regardless of what group they have been assigned to will undergo several outcome assessments (pre-screening, baseline, mid-point, final assessments) conducted by a blinded research assistant. Subjects randomized to the waitlist control group will be offered the same intervention once the active intervention group has completed the active sessions and assessments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention Group

2019

N/A

~50

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,048 Previous Clinical Trials

1,053,763 Total Patients Enrolled

Una Makris, MDPrincipal Investigator - UT Southwestern Medical Center

University of Texas Southwestern Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently recruiting participants for this clinical experiment?

"According to clinicaltrials.gov, this study is actively searching for participants with the first post dating back to August 1st 2019 and the last edit occuring on November 29th 2022."

Answered by AI

What is the core objective of this clinical trial?

"The primary aim of this study, which will span approximately 6 months until completion, is to measure the rate at which patients adhere to the intervention. Secondary objectives include assessing depression using PHQ-9 scores (0-27 with higher values indicating worse symptoms), RMDQ scores (indicating disability related to back pain on a scale from 0-24; larger numbers are more severe) and lastly Pain Scale ratings (measuring intensity on a 0-10 scale where increased numbers indicate greater suffering)."

Answered by AI

How many participants are engaging in this medical investigation?

"Affirmative. The details for the study, which was first posted on August 1st 2019, can be found on clinicaltrials.gov and demonstrate that 50 participants are needed between 2 sites in order to continue this investigation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

MOTIVATE: Moving to Improve Outcomes for Older Adults

Una Makris 2019. "MOTIVATE: Moving to Improve Outcomes for Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03914469.