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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

Must not have

Self-reported dependence on wheelchair, bed-bound, or severe balance impairment (unable to participate in physical activity intervention)

Aged 49 or less

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I rely on a wheelchair, am bed-bound, or have severe balance issues.

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I am 49 years old or younger.

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I haven't been hospitalized for a serious condition like a heart attack or stroke in the last 3 months.

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I do not speak English.

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I have hearing or vision problems that make it hard for me to use a phone or read a pedometer.

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I am not willing to be assigned randomly to a treatment group.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Intervention Completion

Recruitment Rates

Secondary study objectives

Depression

Pain Scale

Roland Morris Disability Questionnaire (RMDQ)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 9Eligibility criteria met