Radiofrequency Ablation: Treatment for Posterior Element Pain From Vertebral Compression Fractures

NCT03651804 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 1198963
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the efficacy of radiofrequency ablation of the medial branch nerves (RFA-MBN) in relieving pain and improving physical function in patients with subacute and chronic vertebral compression fractures (VCF).

Conditions

Vertebral Compression Fracture; Facet Joint Pain

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below.

  VAS pain scale (0-10 scale): Overall, at rest, and in bed at night The VAS Pain scale is a measure of pain intensity. For pain intensity, the scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10). Subjects will report their pain prior to the procedure and at dedicated intervals after to assess change in pain intensity they experience.

  0 weeks, 1 week, 12 weeks, 6 months

Secondary Outcomes (3)

• Roland-Morris Disability Questionnaire at dedicated time frames listed below to assess change.

  0 weeks, 1 week, 12 weeks, 6 months

• QUALEFFO-41 (Quality of Life questionnaire) Scale at dedicated time frames listed below to assess change.

  0 weeks, 1 week, 12 weeks, 6 months

• Patient Health Questionnaire (PHQ-9) at dedicated Time Frames listed below.

  0 weeks, 1 week, 12 weeks, 6 months

Study Arms (3)

Control Group

ACTIVE COMPARATOR

The control group will receive usual care for treatment of vertebral compression fractures, which will consist of but not limited to: physical therapy, opioids, NSAIDs, acetaminophen and bisphosphonates as indicated. They will have the option of crossing over (see "Crossover Group") at twelve weeks.

Drug: Non-steroidal anti-inflammatory drugs; Drug: Bisphosphonates; Drug: Acetaminophen; Behavioral: Physical therapy; Drug: Opioids

Treatment Group

ACTIVE COMPARATOR

The treatment group will receive usual care for treatment and the treatment procedure comprised of the Medial Branch Block and Radiofrequency Ablation. In cases where a medial branch nerve block has confirmed there is pain relief, a radiofrequency ablation is considered. These patients will continue their usual care therapy as well.

Procedure: Radiofrequency ablation of the medial branch nerves; Drug: Non-steroidal anti-inflammatory drugs; Drug: Bisphosphonates; Drug: Acetaminophen; Behavioral: Physical therapy; Drug: Opioids

Crossover Group

ACTIVE COMPARATOR

This group will comprise of patients within the control group who after 12 weeks of usual therapy will have the option of crossing over to the treatment group. Once crossed over, their treatment and course and measurements will be identical to that of the treatment group.

Procedure: Radiofrequency ablation of the medial branch nerves; Drug: Non-steroidal anti-inflammatory drugs; Drug: Bisphosphonates; Drug: Acetaminophen; Behavioral: Physical therapy; Drug: Opioids

Interventions

Radiofrequency ablation of the medial branch nerves PROCEDURE

A radiofrequency ablation (RFA) is a procedure in which a heat lesion via a needle is created on the nerve that transmits the pain signal in order to interrupt the brain to interrupt the painful signal to the brain. We will target the medial branch nerves.

Also known as: RFA-MBB

Crossover Group; Treatment Group

Non-steroidal anti-inflammatory drugs DRUG

Some of the most commonly used pain medicines in adults. NSAIDs block proteins, called enzymes, in the body that play a role in pain and inflammation. They include aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and many other generic and brand name drugs.

Also known as: NSAID

Control Group; Crossover Group; Treatment Group

Bisphosphonates DRUG

A class of drugs that prevent the loss of bone density and are used to treat osteoporosis and similar diseases.

Control Group; Crossover Group; Treatment Group

Acetaminophen DRUG

A medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Commonly known as Tylenol.

Also known as: Tylenol

Control Group; Crossover Group; Treatment Group

Physical therapy BEHAVIORAL

Physical Therapy.

Control Group; Crossover Group; Treatment Group

Opioids DRUG

Opioids are narcotics that act on opioid receptors to produce morphine-like effects and medically they are primarily used for pain relief.

Control Group; Crossover Group; Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

I• Inclusion * 18-90 years old * Male or female * Age of fracture greater than or equal to 6 weeks * Single Level Vertebral Compression Fracture * Vertebral compression fracture Thoraic-9 to Lumbar-5 * NRS \>6/10 • Exclusion * \<18 or \>90 yo * Uncorrectable Coagulopathy * Multiple Level Vertebral Compression Fractures * Surgery within 60 days of presentation * Active infection * Rhuematologic disease * Significant neurologic deficit * Radicular pain * Chronic low back pain in last year * Inability to give consent * Cognitive impairment * Patients with Ongoing Litigation or Worker's Compensation Cases

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Davis, California, 95817, United States

Location

Related Publications (15)

• Boonen S, Van Meirhaeghe J, Bastian L, Cummings SR, Ranstam J, Tillman JB, Eastell R, Talmadge K, Wardlaw D. Balloon kyphoplasty for the treatment of acute vertebral compression fractures: 2-year results from a randomized trial. J Bone Miner Res. 2011 Jul;26(7):1627-37. doi: 10.1002/jbmr.364.

  PMID: 21337428 BACKGROUND

• Wardlaw D, Cummings SR, Van Meirhaeghe J, Bastian L, Tillman JB, Ranstam J, Eastell R, Shabe P, Talmadge K, Boonen S. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009 Mar 21;373(9668):1016-24. doi: 10.1016/S0140-6736(09)60010-6. Epub 2009 Feb 24.

  PMID: 19246088 BACKGROUND

• Klazen CA, Lohle PN, de Vries J, Jansen FH, Tielbeek AV, Blonk MC, Venmans A, van Rooij WJ, Schoemaker MC, Juttmann JR, Lo TH, Verhaar HJ, van der Graaf Y, van Everdingen KJ, Muller AF, Elgersma OE, Halkema DR, Fransen H, Janssens X, Buskens E, Mali WP. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010 Sep 25;376(9746):1085-92. doi: 10.1016/S0140-6736(10)60954-3. Epub 2010 Aug 9.

  PMID: 20701962 BACKGROUND

• Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, Graves S, Staples MP, Murphy B. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009 Aug 6;361(6):557-68. doi: 10.1056/NEJMoa0900429.

  PMID: 19657121 BACKGROUND

• Kallmes DF, Comstock BA, Heagerty PJ, Turner JA, Wilson DJ, Diamond TH, Edwards R, Gray LA, Stout L, Owen S, Hollingworth W, Ghdoke B, Annesley-Williams DJ, Ralston SH, Jarvik JG. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009 Aug 6;361(6):569-79. doi: 10.1056/NEJMoa0900563.

  PMID: 19657122 BACKGROUND

• Johnell O, Kanis JA. An estimate of the worldwide prevalence and disability associated with osteoporotic fractures. Osteoporos Int. 2006 Dec;17(12):1726-33. doi: 10.1007/s00198-006-0172-4. Epub 2006 Sep 16.

  PMID: 16983459 BACKGROUND

• Solberg J, Copenhaver D, Fishman SM. Medial branch nerve block and ablation as a novel approach to pain related to vertebral compression fracture. Curr Opin Anaesthesiol. 2016 Oct;29(5):596-9. doi: 10.1097/ACO.0000000000000375.

  PMID: 27548307 BACKGROUND

• Bogduk N, MacVicar J, Borowczyk J. The pain of vertebral compression fractures can arise in the posterior elements. Pain Med. 2010 Nov;11(11):1666-73. doi: 10.1111/j.1526-4637.2010.00963.x.

  PMID: 21044256 BACKGROUND

• Kim TK, Kim KH, Kim CH, Shin SW, Kwon JY, Kim HK, Baik SW. Percutaneous vertebroplasty and facet joint block. J Korean Med Sci. 2005 Dec;20(6):1023-8. doi: 10.3346/jkms.2005.20.6.1023.

  PMID: 16361816 BACKGROUND

• Park KD, Jee H, Nam HS, Cho SK, Kim HS, Park Y, Lim OK. Effect of medial branch block in chronic facet joint pain for osteoporotic compression fracture: one year retrospective study. Ann Rehabil Med. 2013 Apr;37(2):191-201. doi: 10.5535/arm.2013.37.2.191. Epub 2013 Apr 30.

  PMID: 23705113 BACKGROUND

• Im TS, Lee JW, Lee E, Kang Y, Ahn JM, Kang HS. Effects of Facet Joint Injection Reducing the Need for Percutaneous Vertebroplasty in Vertebral Compression Fractures. Cardiovasc Intervent Radiol. 2016 May;39(5):740-745. doi: 10.1007/s00270-015-1286-x. Epub 2015 Dec 29.

  PMID: 26714695 BACKGROUND

• Mitra R, Do H, Alamin T, Cheng I. Facet pain in thoracic compression fractures. Pain Med. 2010 Nov;11(11):1674-7. doi: 10.1111/j.1526-4637.2010.00953.x. Epub 2010 Oct 1.

  PMID: 21029349 BACKGROUND

• Wang B, Guo H, Yuan L, Huang D, Zhang H, Hao D. A prospective randomized controlled study comparing the pain relief in patients with osteoporotic vertebral compression fractures with the use of vertebroplasty or facet blocking. Eur Spine J. 2016 Nov;25(11):3486-3494. doi: 10.1007/s00586-016-4425-4. Epub 2016 Feb 5.

  PMID: 26850264 BACKGROUND

• Lord SM, Barnsley L, Wallis BJ, McDonald GJ, Bogduk N. Percutaneous radio-frequency neurotomy for chronic cervical zygapophyseal-joint pain. N Engl J Med. 1996 Dec 5;335(23):1721-6. doi: 10.1056/NEJM199612053352302.

  PMID: 8929263 BACKGROUND

• Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.

  PMID: 4139420 BACKGROUND

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Diphosphonates; Acetaminophen; Physical Therapy Modalities; Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Therapeutics; Rehabilitation; Narcotics; Central Nervous System Depressants; Central Nervous System Agents

Study Officials

• David Copenhaver, MD

  UC Davis Medical Center, Department of Anesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 29, 2018
• Study Start: April 10, 2019
• Primary Completion: December 19, 2023
• Study Completion: December 19, 2023
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)