CLINICAL TRIAL

Treatment for Low Back Pain

Class I
EnrollingByInvitation · 18 - 65 · All Sexes · Cleveland, OH

Yoga for Chronic Low Back Pain in the Cleveland Clinic Employee Health Plan

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About the trial for Low Back Pain

Eligible Conditions
Low Back Pain · Chronic Pain · Back Pain

Treatment Groups

This trial involves a single treatment. Treatment is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Yoga
BEHAVIORAL

Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
18-64 years old
You have LBP that persists for at least 12 weeks and is severe enough to interfere with your daily activities. show original
Ability to speak and understand English
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Weeks 12 and 24
Screening: ~3 weeks
Treatment: Varies
Reporting: Weeks 12 and 24
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Weeks 12 and 24.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Treatment will improve 2 primary outcomes, 5 secondary outcomes, and 2 other outcomes in patients with Low Back Pain. Measurement will happen over the course of Weeks 12 and 24.

Patient Reported Outcomes Measurement Information System (PROMIS) Item Bank v1.0 - Pain Interference - Short Form 4a
WEEKS 12 AND 24
PROMIS Pain domain asks 4 questions. Each question is rated from 1 to 5. Values are summed to create a total raw score. Raw scores are minimum 4 to maximum 20 and translate to a T score with a minimum 41.6 to maximum 75.6. A higher score equates to a higher pain interference.
WEEKS 12 AND 24
Self-reported average pain intensity for the previous week
BASELINE
11 point numerical rating scale ranging from 0=no pain to 10=worst possible pain
BASELINE
Total Medical Expenditures for low back pain
BASELINE TO WEEK 24
Total and back-related medical expenditures for all participants for the six month study period will be compared between the yoga (Arm 1) and wait-list (Arm 2) control groups. Cost of implementing the intervention will be measured to demonstrate the feasibility of evaluating cost-effectiveness of yoga compared to usual care for cLBP from the perspective of the payer.
BASELINE TO WEEK 24
Participant Satisfaction
BASELINE TO WEEK 24
Acceptability will be measured by participant satisfaction with treatment (5-point Likert scale, 1 = very dissatisfied to 5 = very satisfied) and answers to open-ended questions about the effect of yoga, facilitators and barriers.
BASELINE TO WEEK 24
Change of self-reported back-related function
WEEK 24
Modified Roland Morris Disability Questionnaire ranging from 0=no functional impairment to 23=worst impairment of function
WEEK 24
Analgesic use
WEEK 24
Change of self-reported pain medications usage; dosage reported in milligrams
WEEK 24
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Patient Q & A Section

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Other questions from users

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any geographic restrictions to consider when applying for this trial?

Patients from any state can participate in this trial, so long as they are able to attend all treatment sessions.

Will my insurance cover participating in this trial?

In order to understand how insurance coverage works for this trial, you will need to contact the study coordinator.

See if you qualify for this trial
Get access to this novel treatment for Low Back Pain by sharing your contact details with the study coordinator.