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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)
Willingness to and ability to participate in study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, 6 weeks visit , 3 months visit , 1 year visit , 2 years visit
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Select...
I am willing and able to follow the study's procedures.
Select...
I have had back pain above my buttocks for at least 3 months.
Select...
I have had back pain above my buttocks for at least 3 months.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in ODI (Oswestry Disability Index)
Changes in SF-36 (Short Form (36) Health Survey )
Changes in VAS(visual analog scale)
Secondary outcome measures
Long term changes in ODI after intervention
Long term changes in SF-36 after intervention
Long term changes in VAS after intervention
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
1,363 Previous Clinical Trials
816,236 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 am willing and able to follow the study's procedures.I have had back pain above my buttocks for at least 3 months.I have had back pain above my buttocks for at least 3 months.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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this study still open to new participants?
"Affirmative. Clinicaltrials.gov has an entry for this clinical trial, dated December 1st 2019 with a most recent edit on February 3rd 2022. This study requires 200 participants from one site to take part in the research project."
Answered by AI
What is the cumulative figure of individuals taking part in this clinical research?
"Affirmative. Prospective candidates can find corroborating evidence on clinicaltrials.gov, which states that the trial was first posted on December 1st 2019 and presently requires 200 individuals to be recruited from one medical site."
Answered by AI
Who else is applying?
What state do they live in?
New York
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
NYULangone
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I’ve tried several methods of alleviating my pain nothing has worked. I’ve had an awful amount of back pain since my young childhood . With nothing helping I’m looking to explore the uses of yoga.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long is the screening process?
PatientReceived 2+ prior treatments
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