Dallas, TXNCT04085406Now EnrollingIRB Ready

Chronic Low-back Pain Clinical Trial in Dallas, TX

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

Sponsored by University of California, Los Angeles

Quick Self-Assessment

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Expert Care in Dallas

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

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Check if you qualify for this chronic low-back pain clinical trial in Dallas, TX

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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 Dallas

    Convenient for TX 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 Dallas site if eligible
  4. 4Begin participation

About This Chronic Low-back Pain Study in Dallas

The purpose of this study is to evaluate the feasibility and preliminary efficacy of deep brain stimulation of the subgenual cingulate cortex for the treatment of chronic medically-refractory low back pain using a randomized double-blind crossover design.

Sponsor: University of California, Los Angeles

Who Can Participate

Inclusion Criteria

Pain secondary to failed back surgery syndrome (FBSS) as defined by persistent low back pain despite prior surgical interventions.
Self-reported average back pain intensity of greater than 8 out of 10 on the Visual Analog Scale (VAS) documented over greater than 2 years.
Failure to achieve at least 50% pain relief from a trial of spinal cord stimulation (SCS) or less than 50% pain relief after 3 months of SCS therapy or patient refuses/rejects SCS trial
Failure to achieve at least 50% pain relief in response to at least 4 weeks of physical therapy.
Failure to achieve at least 50% pain relief in response to at least 2 percutaneous spinal pain procedures.
Failure to achieve at least 50% pain relief in response to 3 months of opioid therapy (at least 20 MEQ/day) or inability to increase or tolerate opioid therapy due to dose-limiting side effects).
Failure to achieve at least 50% pain relief in response to a 3-month trial of at least one other class of pain medication in addition to opioid therapy or inability to tolerate increasing doses of non-opioid pain medications due to dose-limiting side effects.
Lack of a surgically correctible etiology for the pain as determined by 2 independent neurosurgeons
Age greater than 40 years of age.
Ability to give informed consent in accordance with institutional policies and participate in the 1.5-year follow-up, involving assessments and stimulator adjustments.
Willingness to share unexpected neurological or psychiatric symptoms with study clinicians.

Exclusion Criteria

Significant neurocognitive impairment (MoCA \< 26).
Age \> 75 years.
History of implant-related infection.
History of bleeding disorder or immune-compromise.
Psychiatric comorbidity other than depression or generalized anxiety disorder, as determined by MINI International Neuropsychiatric Interview.
Patients with neurological diagnoses that may reduce the response to or increase the risk of DBS including neurodegenerative conditions, severe movement disorders, demyelinating disorders, syringomyelia, epilepsy or history of seizures, history of CNS tumors (spinal and/or cranial), history of serious head injury with loss of consciousness, history of stroke, surgically reversible peripheral pain syndromes including surgically correctable radiculopathy, and severe peripheral neuropathy.
Patients who have undergone spine surgery within the previous 3 months.
Major medical co-morbidities increasing the risk of surgery including uncontrolled hypertension, severe diabetes, major organ system failure, history of hemorrhagic stroke, need for chronic anticoagulation, active infection, immunocompromised state or malignancy with \< 5 years life expectancy.
Individuals with a currently implanted SCS device.
Individuals with a life expectancy less than 1 year due to any cause.
Individuals involved in an injury claim under current litigation.
Individuals with a pending or approved worker's compensation claim.
Patient living greater than 100 miles from UCLA.
Suicide attempt in the last two years and/or presence of a suicide plan (an answer of Yes to Question C4 in Section C- Suicidality of MINI International Neuropsychiatric Interview).
Alcohol or illicit substance use disorder (other than nicotine) within the last 6 months, unstable remission of substance abuse, or chart evidence that co-morbid substance use disorder could account for lack of treatment response.
Uncontrolled medical condition including cardiovascular problems and diabetes.
Pregnant or planning to become pregnant.
Use of warfarin or other blood thinners.
Significant structural abnormality on preoperative brain MRI.
Contraindications to MRIs or the need for recurrent body MRIs.
Presence of cardiac pacemakers/defibrillators, implanted medication pumps, intra-cardiac lines, any intracranial implants (e.g., aneurysm clip, shunt, cochlear implant, electrodes) or other implanted stimulators.
History of prior cranial neurosurgery.
Patients unable to discontinue any existing therapeutic diathermy.
Individuals who are concomitantly participating in another clinical study.

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 Dallas?

Yes, this clinical trial (NCT04085406) has an active research site in Dallas, TX 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 Dallas, TX

If you're searching for chronic low-back pain treatment options in Dallas, TX, this clinical trial (NCT04085406) 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 Dallas 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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