Is NCT07214844 recruiting in The Bronx, NY?

Yes, NCT07214844 is currently recruiting participants at its The Bronx, NY location. This low back pain, chronic clinical trial is actively enrolling qualified participants.

How do I join the low back pain, chronic clinical trial in The Bronx?

To join this clinical trial in The Bronx, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this The Bronx clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Low Back Pain, Chronic Clinical Trial in The Bronx, NY

About This Low Back Pain, Chronic Study in The Bronx

A research study is being conducted to compare two treatments for long-term low back pain: * One uses the iovera° system, which applies cold to certain nerves in the lower back. * The other is the standard treatment called radiofrequency ablation, which uses heat. The primary objective is to find out which treatment works better to reduce back pain. Participants in this study will be randomly placed in one of the two treatment groups. The clinical research team will check on participant pain levels and overall health before and after the procedure for about 12 months. The entire study will last about 14 months for each participant.

Sponsor: Montefiore Medical Center

Who Can Participate

Inclusion Criteria

Subjects must meet all of the following inclusion criteria to be eligible for participation:

Subjects at least 18 years of age at Screening

Primary complaint of axial low-back pain suggestive of bilateral facet joint involvement (i.e., facet mediated CLBP) by evidence of provocative testing (e.g., axial loading, paraspinal tenderness)

Low back pain is chronic (i.e., ≥ 3 months' duration)

Low back pain is moderate to severe (score of ≥ 5 to ≤ 9) on the 0 to 10 NRS at Screening

Low back pain causes functional impairment (≥ 30% on ODI) at Screening

Successful trial of two diagnostic medial branch blocks consisting of two positive blocks with local anesthetic only (i.e., no steroids) that results in at least 80% relief of primary (index) pain for the duration of the local anesthetic used

Failure of at least three months of conservative non-operative therapy (e.g., physical therapy, chiropractic care, sleep hygiene, weight loss, spinal injections, NSAIDs, physician-directed exercise program or other appropriate analgesics)

Able to provide informed consent, adhere to the study visit schedule, and complete all study assessment

Exclusion Criteria

Subjects who meet any of the following exclusion criteria will not be eligible for participation in this study:

Active workers' compensation, personal injury, Social Security disability insurance (SSDI), or other litigation/compensation related to the spine

Serious spinal disorders (verified on magnetic resonance imaging (MRI)) that may impact outcomes, including any of the following:

Suspected cauda equina syndrome (e.g., bowel/bladder dysfunction)

Traumatic fracture

Systemic inflammatory spondyloarthropathy

Lumbar radiculopathy/radiculitis (i.e., root irritation and deficit)

Neurogenic claudication Prior lumbar spinal fusion surgery at the intended treatment levels

Comorbidity that, in the judgment of the Investigator, may affect the subject's ability to participate in the study including lumbar radiculopathy and neuropathic pain disorder

Currently pregnant, nursing, or planning to become pregnant during the study

Known contraindication to study device, including any of the following:

Cryoglobulinemia

Paroxysmal cold hemoglobinuria

Cold urticaria

Raynaud's disease

Open and/or infected wounds at or near the treatment site

Coagulopathy

Severe chronic pain disorder that in the opinion of the investigator may impact study outcomes

Presence of any of the following:

Spinal neurostimulator

Intrathecal analgesic drug pump

Cardiac implantable device

Current manifestation of poorly controlled mental illness or catastrophizing that in the opinion of the investigator may meaningfully impact treatment outcomes, including any of the following:

Mood disorder (e.g., depression, bipolar) Patient Health Questionnaire (PHQ-9) ≥ 12 at Screening

Psychotic disorder (e.g., schizophrenia)

Catastrophizing Patient Catastrophizing Scale (PCS) score \> 30 at Screening

Subject received other spine intervention/therapies in the 30 days prior to block administration (e.g., spinal injections, minimally invasive therapies, surgical therapies) at the intended lumbar treatment levels

Subject received radiofrequency ablation in the low back region ≤ 6 months before study enrollment at the intended lumbar treatment levels

Pain relief following diagnostic medial branch blocks lasted longer than the duration of the local anesthetic used (i.e., \> 24 hours)

History, suspicion, or clinical manifestation of:

Alcohol abuse or dependence

Illicit drug use

Opioid abuse or dependence (≥40 mg medication PO/day in past 30 days)

Given the COVID-19 pandemic, the subject must be medically fit/cleared for surgery by the investigator. If there is a concern about a subject's recent or potential exposure to COVID-19, or if the subject is not medically fit/cleared for surgery due to suspected COVID-19 illness/symptoms (or other serious illness), the subject must be excluded.

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 The Bronx?

Yes, this clinical trial (NCT07214844) has an active research site in The Bronx, NY 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.

Low Back Pain, Chronic Treatment Options in The Bronx, NY

If you're searching for low back pain, chronic treatment options in The Bronx, NY, this clinical trial (NCT07214844) 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 The Bronx research site is actively enrolling participants for this clinical trial. You'll receive care from experienced low back pain, chronic 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 low back pain, chronic clinical trials near you to find additional studies recruiting in your area.

Low Back Pain, Chronic Clinical Trial in The Bronx, NY

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