Indianapolis, INNCT04142177Now EnrollingIRB Ready

Chronic Low Back Pain Clinical Trial in Indianapolis, IN

Access cutting-edge chronic low back pain treatment through this clinical trial at a research site in Indianapolis. Study-provided care at no cost to qualified participants.

Sponsored by VA Office of Research and Development

Quick Self-Assessment

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Expert Care in Indianapolis

Access chronic low back pain specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related chronic low back pain treatment provided free

Apply for This Indianapolis Location

Check if you qualify for this chronic low back pain clinical trial in Indianapolis, IN

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Indianapolis

    Convenient for IN residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Indianapolis site if eligible
  4. 4Begin participation

About This Chronic Low Back Pain Study in Indianapolis

VETERANS ONLY. Chronic low back pain (cLBP) is common. Most Americans will have at least one episode of low back pain in their lifetimes. Approximately 50% of all US Veterans have chronic pain, and CLBP is the most common type of pain in this population. This study will use a sequential randomized, pragmatic, 2-step comparative effectiveness study design. The main goal is to identify the best approach for treating cLBP using commonly recommended non-surgical and non-pharmacological options. The first step compares continued care and active monitoring (CCAM) to internet-based pain self-management (Pain EASE) and an enhanced physical therapy intervention that combines Pain EASE with tailored exercise and physical activity. Patients who do not have a significant decrease in pain interference (a functional outcome) in Step 1 and those desiring additional treatment will be randomized in Step 2 to yoga, spinal manipulation therapy (SMT), or therapist-delivered cognitive behavioral therapy (CBT). Participants proceeding to randomization in Step 2 will be allowed to exclude up to one of the three Step 2 treatments based on their preferences. The investigators' primary hypothesis for the first treatment step is that an enhanced physical therapy intervention that combines pain self-management education with a tailored exercise program will reduce pain interference greater than internet-based pain self-management alone or CCAM in Veterans with cLBP. The primary outcome is change in pain interference at 3 months, measured using the Brief Pain Inventory (BPI) pain interference subscale. Study participants will be followed for one year after initiation of their final study treatments to assess the durability of treatment effects. The study plans to randomize 2529 patients across 20 centers.

Sponsor: VA Office of Research and Development

Who Can Participate

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all the following criteria:
Low back pain
present for at least 6 months,
present most days or everyday,
interferes the most with activities considering all of the places where the patient experiences pain;
Pain, Enjoyment, General Activity (PEG) score of 4 or greater;
Veteran age 18 years or older, either sex, any racial or ethnic background;
Able to comprehend and willing to sign the study informed consent form;
Able and willing to attend in-person treatment sessions;
Anticipate continuing care at the enrolling VA for the period of the study;
Stable access to the internet at home, work, or other location (e.g. mobile phone), and an email address.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
Currently enrolled in any other interventional study unless exempted by CSP;
Acute or chronic illness that would prevent the Veteran from receiving study treatments offered (e.g., uncontrolled hypertension, recent myocardial infarction within the last 6 months, unstable angina, acute congestive heart failure);
Neurological impairment related to disease of the spine or other causes preventing participation in any of the treatment modalities under study;
Current or recent (last 3 months) treatment involving Cognitive Behavioral Therapy, Spinal manipulation therapy, or Yoga;
Current severe alcohol or substance abuse use disorder;
Severe psychiatric illness (e.g. current psychosis, current suicidal ideation, or psychiatric illness requiring hospitalization within the last 6 months);
Back surgery within the last 6 months, or undergoing evaluation for back surgery or planned back surgery;
Cognitive or severe hearing or visual impairment preventing participation in treatment options or outcome measure assessments;

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Indianapolis?

Yes, this clinical trial (NCT04142177) has an active research site in Indianapolis, IN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Chronic Low Back Pain Treatment Options in Indianapolis, IN

If you're searching for chronic low back pain treatment options in Indianapolis, IN, this clinical trial (NCT04142177) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Indianapolis research site is actively enrolling participants for this clinical trial. You'll receive care from experienced chronic low back pain specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all chronic low back pain clinical trials near you to find additional studies recruiting in your area.

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