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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic back pain (pain above the gluteal cleft of at least 3 months duration)
Be older than 18 years old
Must not have
Indication for surgery (i.e., fracture, infection, scoliosis, spondylolisthesis)
Cardiac, pulmonary or other medical comorbidities that preclude participation in yoga practice
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, 6 weeks visit , 3 months visit , 1 year visit , 2 years visit
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying whether yoga can help people with chronic low back pain.
Who is the study for?
This trial is for individuals who have been experiencing chronic back pain for at least three months. Participants should be willing and able to follow the study procedures. It's not suitable for those needing surgery due to conditions like fractures or infections, or with heart, lung, or other health issues that make yoga practice unsafe.
What is being tested?
The trial is exploring how a structured yoga program might help people manage chronic low back pain, which often leads to missed work days and can contribute to opioid use. The aim is to see if yoga can be an effective non-surgical treatment option.
What are the potential side effects?
Yoga is generally considered safe but may include side effects such as muscle soreness or strain, especially if poses are done incorrectly. People with certain medical conditions may experience adverse effects; hence they are excluded from this trial.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had back pain above my buttocks for at least 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need surgery for a condition like a broken bone, infection, or spine issue.
Select...
I have health issues that prevent me from doing yoga.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline visit, 6 weeks visit , 3 months visit , 1 year visit , 2 years visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit, 6 weeks visit , 3 months visit , 1 year visit , 2 years visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in ODI (Oswestry Disability Index)
Changes in SF-36 (Short Form (36) Health Survey )
Changes in VAS(visual analog scale)
Secondary study objectives
Long term changes in ODI after intervention
Long term changes in SF-36 after intervention
Long term changes in VAS after intervention
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: Yoga ArmExperimental Treatment1 Intervention
The study arm will involve a yoga protocol devised by Eddie Stern - a renowned Ashtanga yoga practitioner, and can include NSAIDs.
Group II: Control armActive Control1 Intervention
The control arm will involve usual care - 6 weeks of physical therapy, NSAIDs, and epidural steroid injections
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yoga program
2018
N/A
~60
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,409 Previous Clinical Trials
855,388 Total Patients Enrolled
Erich AndererPrincipal InvestigatorNYU Langone Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing and able to follow the study's procedures.I need surgery for a condition like a broken bone, infection, or spine issue.I have health issues that prevent me from doing yoga.I have had back pain above my buttocks for at least 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Control arm
- Group 2: Yoga Arm
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.
Chronic Back Pain Patient Testimony for trial: Trial Name: NCT04270617 — N/A
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