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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 weeks and 3 months and 6 months
Awards & highlights
PATH Trial 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.Check my eligibility
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.See study design
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.
PATH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
My pain management treatment has been the same for the last month.
Select...
I have experienced low back pain for more than 3 months in the last half year.
PATH Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Emotion regulation abilities
Secondary outcome measures
Pain sensitization
Pain severity/interference
PATH 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.
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,700 Previous Clinical Trials
7,506,662 Total Patients Enrolled
University of ConnecticutLead Sponsor
183 Previous Clinical Trials
157,969 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
832 Previous Clinical Trials
668,769 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had back surgery in the past year.I agree to keep my pain treatment the same during the study unless a change is needed for my health.I am willing to do yoga or stretching twice a week for 12 weeks.I have a chronic pain condition like migraines or fibromyalgia.I have a serious health condition like another cancer, severe lung disease, or extreme obesity.I am older than 18 years.I have balance issues confirmed by a Romberg test.My pain management treatment has been the same for the last month.I have some weakness in my legs but can still move them.I have sciatica or a positive straight leg raise test.My back pain is caused by a condition like lupus.You have a severe mental illness that is not well controlled.I have experienced low back pain for more than 3 months in the last half year.You have not done yoga more than twice in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Physical activity + emotion regulation group
- Group 2: Physical activity control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible for more participants to join this clinical investigation?
"Affirmative. According to information on clinicaltrials.gov, this medical research project is recruiting participants and was first advertised on October 1st 2020. The most recent update occurred on October 31st 2022 and the study requires 204 individuals from one centre."
Answered by AI
What is the sample size of participants engaging in this clinical trial?
"Yes, according to clinicaltrials.gov the trial was initially posted on October 1st 2020 and has recently been updated on October 31st 2022. The study is recruiting 204 patients from one research site."
Answered by AI
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