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Physical Activity + Emotion Regulation for Lower Back Pain (PATH Trial)

N/A

Recruiting

Led By Crystal Park, PhD

Research Sponsored by University of Connecticut

Eligibility Criteria Checklist

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

Must have

Age > 18

No changes in pain treatments in the past month

Must not have

Back surgery within the last 1 year

Major coexisting medical illness (e.g., cancer, COPD, morbid obesity)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 6 weeks and 3 months and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand how different forms of exercise help people with chronic back pain, so that they can better design workout programs to relieve pain.

Who is the study for?

This trial is for adults over 18 with chronic low back pain lasting more than half of the past six months. Participants must be willing to attend a 12-week yoga or stretching program, complete assessments, and not change their current pain treatments unless necessary. It's not for those with specific systemic causes of back pain, recent back surgery, certain muscle weakness, serious psychiatric or major medical conditions.

What is being tested?

The study is testing two interventions: one combines physical activity with emotion regulation techniques; the other is a control intervention focusing on physical activity alone. The goal is to see which method better improves outcomes for people suffering from chronic low back pain.

What are the potential side effects?

While the trial does not involve medication and thus has minimal risk of side effects typical to drugs, participants may experience soreness or discomfort from increased physical activity such as yoga or stretching exercises.

Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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My pain management treatment has been the same for the last month.

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I have experienced low back pain for more than 3 months in the last half year.

Exclusion Criteria

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

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I have not had back surgery in the past year.

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I have a serious health condition like another cancer, severe lung disease, or extreme obesity.

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I have balance issues confirmed by a Romberg test.

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I have some weakness in my legs but can still move them.

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I have sciatica or a positive straight leg raise test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 6 weeks and 3 months and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 6 weeks and 3 months and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 6 weeks and 3 months and 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

Emotion regulation abilities

Secondary study objectives

Pain sensitization

Pain severity/interference

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: Physical activity + emotion regulation groupExperimental Treatment1 Intervention

Participants randomized to the experimental group attend two group-based class sessions per week, each 1.25hours long, that are led by certified instructors who guide participants through various exercises. Participants are encouraged to practice the activities at home for 20 minutes each day.

Group II: Physical activity control groupActive Control1 Intervention

Participants randomized to the control group attend two group-based class sessions per week, each 1.25hours long, that are led by trained therapists who guide participants through a series of stretching exercises. Participants are encouraged to practice the activities at home for 20 minutes each day.

0 / 8Eligibility criteria met