Cooled Radiofrequency for Low Back Pain

Phase-Based Estimates
1
Effectiveness
1
Safety
The Spine and Nerve Centers of St. Francis Hosptial, Charleston, WV
Low Back Pain+2 More
Cooled Radiofrequency - Device
Eligibility
18+
All Sexes
Eligible conditions
Low Back Pain

Study Summary

This study is evaluating whether a specific type of radiofrequency procedure may help reduce pain in individuals with chronic low back pain.

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Eligible Conditions

  • Low Back Pain
  • Back Pain
  • Chronic Lower Back Pain (CLBP)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Cooled Radiofrequency will improve 2 primary outcomes, 5 secondary outcomes, and 7 other outcomes in patients with Low Back Pain. Measurement will happen over the course of 6 months.

12 months
Proportion of subjects experiencing adverse events through 12 months
The mean change in EQ-5D-5L score from baseline to the 12-month visit
The mean change in Oswestry Disability Index (ODI) score from baseline to the 12-month visit
The mean change in SF-36 Physical Functioning (PF) score from baseline to the 12-month visit
The measured Global Perceived Effect scale at the 12-month visit
The proportion of subjects requiring additional intervention for their back pain during the 12-month period
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 12 Months
6 months
Proportion of subjects experiencing adverse events through 6-months
The mean change in EQ-5D-5L score from baseline to the 6-month visit
The mean change in Oswestry Disability Index (ODI) score from baseline to the 6-month visit
The mean change in SF-36 Physical Functioning (PF) score from baseline to the 6-month visit
The measured Global Perceived Effect scale at the 6-month visit
The proportion of subjects requiring additional intervention for their back pain during the 6-month period
The proportion of subjects whose back pain is reduced by ≥ 50 percent based on the NRS scale at 6 Months

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Conventional Radiofrequency
Cooled Radiofrequency

This trial requires 188 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cooled Radiofrequency 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.

Cooled Radiofrequency
Device
Cooled radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Conventional Radiofrequency
Device
Conventional radiofrequency energy will be delivered to target medial branch nerves in the lower back to reduce pain
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cooled Radiofrequency
2017
N/A
~330

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 12 months for reporting.

Closest Location

The Spine and Nerve Centers of St. Francis Hosptial - Charleston, WV

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The patients who received dual diagnostic medial branch blocks with 0.5mL or less of 0.5% bupivacaine and 2% lidocaine experienced a decrease in numeric pain scores of at least 80% for a minimum of 3 hours on each encounter. show original
Participants in this study must be willing to use a double barrier contraceptive method for the duration of the study. show original
Can read and write, and is capable of understanding what is written in an informed consent form, and providing written consent indicating understanding show original
People who have chronic low back pain that is not caused by a nerve problem in their back, and that is likely caused by arthritis in the joints near the spine, may be able to have surgery to fix the problem show original
During the study period, agree to see only one physician for back pain. show original
Analgesics, including membrane stabilizers such as Neurontin (gabapentin) and antidepressants for pain such as Cymbalta (duloxetine), must be clinically stable (defined as having a stable dosage for ≥6 weeks prior to the screening visit) and shall not change during the study without approval of the investigator. show original
Age ≥ 21 years
The average pain score is six or higher on an eleven-point NRS scale. show original
Agreement to follow the guidelines of this study for the entire period of the research. show original

Patient Q&A Section

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

What are the signs of low back pain?

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Patients will present with low [back pain](https://www.withpower.com/clinical-trials/back-pain). Their complaints are most likely to be associated with movement impairment. Symptoms often relate to spinal disk pathology. Low-back pain can be a significant burden to patients, to carers and to the society as a whole.

Unverified Answer

What causes low back pain?

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In this population presenting for clinical care, LBP is common (>80%) and is strongly correlated with low social status. Although physical and psychological exertion were associated with LBP, only emotional factors were associated with severity. These data will help inform the design and content of treatment programs to address individual factors (physical, psychological, and social) contributing to LBP.

Unverified Answer

What are common treatments for low back pain?

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The main treatments are either medical management or chiropractic care. Many people find chiropractic care helpful and preferred. Other treatments tried include medical intervention, occupational therapy, and physical therapy.\n\nMedical use of alternative medicine varies due to lack of research, and is not fully addressed in medical school.\n\nMany medical specialties are concerned with disorders of the nervous system including physical medicine and rehabilitation, neurology, neurosurgery, psychiatry, neurology, physiatry, pain medicine, physiatry, behavioral neurology, functional imaging, critical care.

Unverified Answer

How many people get low back pain a year in the United States?

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The prevalence of new back pain cases is stable over time and does not vary greatly from year to year. Results from a recent paper are consistent with the theory that new back pain will develop more often when work demands are higher and that recovery from low back pain will occur slowly but with no long-term morbidity.

Unverified Answer

What is low back pain?

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The data clearly demonstrate that there is an increased occurrence of low back pain among people at work with a history of low back pain at home. If confirmed by similar studies this may have significant repercussions on the ability of employees to perform or to work, in such cases, in organisations where work is a key facet to the well-being and quality of life of people.

Unverified Answer

Can low back pain be cured?

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All patients with disabling LBP had some improvement after surgery. Patients with a high level of disability before surgery were less likely to have improvement.

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Is cooled radiofrequency typically used in combination with any other treatments?

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The combination of a radiofrequency and other treatments does not result in a lower rate of treatment success in the management of low back pain.

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What are the latest developments in cooled radiofrequency for therapeutic use?

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The current research has produced an efficient, quick, low cost method for treatment of low back pain. Additional studies on long-term effects remain necessary, but the results are positive, especially as further improvements in cooling performance and applicability are achieved.

Unverified Answer

Have there been other clinical trials involving cooled radiofrequency?

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There is a high level of evidence to support the potential benefit of cool radiofrequency (RF) therapy for the treatment of soft tissue pain; however, a small number of randomized controlled trials have been conducted, and a large number of uncontrolled studies have been published in the literature. There has been some evidence suggesting that RF therapy might be effective and safe in the treatment of a broad range of soft tissue and musculoskeletal (including soft tissue pain disorders and musculoskeletal conditions) pain conditions; and there is a high level of evidence suggesting that there may be some benefit to cooler RF therapy in chronic lower back pain. The use of RF therapy deserves further consideration in research trials and in clinical practice.

Unverified Answer

Does cooled radiofrequency improve quality of life for those with low back pain?

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Patients experienced significant pain relief and improved physical and emotional functioning after 6-month treatment. The improvement persisted over time. CRIQ may be a valuable tool in outcome evaluation for the management of patients with chronic low back pain.

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Is cooled radiofrequency safe for people?

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A cooling device of the [HIVEMEDTRAC] type was not associated with adverse effects after a mean cumulative RF energy administration of 42,050J. The cooling device used in this study was not suitable for people but was recommended in another study to provide a cooling medium to the internal RF application region while RF is being administered.

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Has cooled radiofrequency proven to be more effective than a placebo?

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Although there are no clear guidelines, clinicians should consider adding CRF to analgesia options and treatment protocols in patients with persistent non-radicular diskogenic LBP after adjusting medication dosage and frequency.

Unverified Answer
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