Vertebral Compression FracturePhase 4NCT03651804

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

A Phase 4 study testing Radiofrequency ablation of the medial branch nerves, Non-steroidal anti-inflammatory drugs and Bisphosphonates in people with Vertebral Compression Fracture and Facet Joint Pain, run by University of California, Davis at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Vertebral Compression Fracture, Facet Joint Pain
What is being tested?: Radiofrequency ablation of the medial branch nerves, Non-steroidal anti-inflammatory drugs and Bisphosphonates
Type of treatment: Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 10 Apr 2019to 19 Dec 2023
Phase: Phase 4
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Davis Medical Center
Davis, California, 95817

Other trials in United States

About this study

Official title: Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures

Read the detailed description

The study examines a novel approach to treat pain associated with VCFs. The usual care therapy currently involves utilizing physical therapy, non-steroidal anti-inflammatory medications, opioids, and bone re-building medications known as bisphosphonates. A usual treatment plan may include some, if not all the above. There is growing evidence that the posterior spinal elements contribute to pain that patients with VCFs experience. RFA-MBN, which targets these posterior spinal elements, may provide more sustained pain relief and improved physical function compared to usual care for these fractures. The procedure essentially "ablates with heat" the medial branch nerves which send pain signals from the posterior elements to the brain.

Patients will be randomly selected into one of two groups. The treatment group will receive the RFA-MBN procedure along with usual care therapy. The control group will undergo usual care. The control group will have the option to cross over to receive RFA-MBN at a defined interval during the study. There will be follow up visits at various intervals to compare pain relief and function based on various surveys of the treatment, control, and cross-over groups.

Conditions: Vertebral Compression Fracture, Facet Joint Pain
Being tested: Radiofrequency ablation of the medial branch nerves, Non-steroidal anti-inflammatory drugs, Bisphosphonates, Acetaminophen, Physical therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiofrequency ablation of the medial branch nervesProcedure or surgery
Also called RFA-MBB
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.
Non-steroidal anti-inflammatory drugsDrug
Also called NSAID
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.
BisphosphonatesDrug
A class of drugs that prevent the loss of bone density and are used to treat osteoporosis and similar diseases.
AcetaminophenDrug
Also called Tylenol
A medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Commonly known as Tylenol.
Physical therapyBehavioural
Physical Therapy.
OpioidsDrug
Opioids are narcotics that act on opioid receptors to produce morphine-like effects and medically they are primarily used for pain relief.

Study groups in NCT03651804
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Procedure: Radiofrequency ablation of the medial branch nerves; Drug: Non-steroidal anti-inflammatory drugs; Drug: Bisphosphonates; Drug: Acetaminophen; Behavioral: Physical therapy; Drug: Opioids

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 0 weeks, 1 week, 12 weeks, 6 months

Secondary outcomes (3)

Roland-Morris Disability Questionnaire at dedicated time frames listed below to assess change.
The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale. The RMQ has been shown to yield reliable measurements, which are valid for inferring the level of disability, and to be sensitive to change over time for groups of patients with low back pain. It is a series of 24 questions in which a "Yes" response appoints one point. A total score of is 24 possible. Clinical improvement over time can be graded based on the analysis of serial questionnaire scores. If, for example, at the beginningof treatment, a patient's score was 12 and, at the conclusion of treatment, her score was 2 (10 points of improvement), we would calculate an 83% (10/12 x 100) improvement.
Measured: 0 weeks, 1 week, 12 weeks, 6 months
QUALEFFO-41 (Quality of Life questionnaire) Scale at dedicated time frames listed below to assess change.
The Qualeffo-41 is a specific quality of life instrument, which is developed for patients with vertebral compression fractures. This questionnaire comprised of 41 questions, covers main aspects of quality of life: pain, physical functions, social functions, general health and mental health. All answers are standardized so that 1 represents the best and 5 (or 3, or 4) represents the worst quality of life (reverse scores on questions 33, 34, 35, 37, 39, 40). The total score is calculated by summing all answers of questions 1-41. The raw total score ranges from 41 to 205 (or less when some answers are missing) and this is transformed to scores from 0 to 100. The higher the score the poorer the quality of life.
Measured: 0 weeks, 1 week, 12 weeks, 6 months
Patient Health Questionnaire (PHQ-9) at dedicated Time Frames listed below.
The PHQ-9 is a multipurpose instrument for monitoring and measuring the severity of depression. The PHQ-9 incorporates leading major depressive symptoms into a brief self-report tool. It is comprised of a series of 9 questions that assess a series of feelings/symptoms related to clinical depression over the past two weeks and are graded on a scale of 0-3 (gradation of not at all 0 to every day 3). The scores are tallied up for a total score of 0 to 27. The higher the score the greater the severity of the depression.
Measured: 0 weeks, 1 week, 12 weeks, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Apr 201919 Dec 2023

First posted29 Aug 2018
Study start10 Apr 2019
Primary completion19 Dec 2023
Study completion19 Dec 2023

Why it stopped: Difficulty recruiting members

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Vertebral Compression FractureStudies of the same condition, open and under way.
More trials run by University of California, DavisThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03651804
Sponsor's protocol ID: 1198963
Status last verified: Jul 2025
First submitted: 14 Aug 2018
Last updated: 16 Jul 2025
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 21337428
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.
PubMed 19246088
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.
PubMed 20701962
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.
PubMed 19657121
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.
PubMed 19657122
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.
PubMed 16983459
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.
PubMed 27548307
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.
PubMed 21044256
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.
PubMed 16361816
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.
PubMed 23705113
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.
PubMed 26714695
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.
PubMed 21029349
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.
PubMed 26850264
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.
PubMed 8929263
Huskisson EC. Measurement of pain. Lancet. 1974 Nov 9;2(7889):1127-31. doi: 10.1016/s0140-6736(74)90884-8. No abstract available.
PubMed 4139420

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingPhase 2
Trial of Combined Radiotherapy and Vertebroplasty for Patients With Painful Metastatic Spinal Lesions
Spinal Metastases
RecruitingObservational study
Prospective Evaluation of Therapeutic Combination in Treating Vertebral Compression Fractures
Vertebral Compression Fractures, Pathological Fracture
Active, not recruitingPhase 2
Cement Augmentation in Preventing Vertebral Body Compression Fracture Following Spine Stereotactic Radiosurgery in Patients With Solid Tumors and Spinal Metastases
Metastatic Malignant Neoplasm in the Spine, Metastatic Malignant Solid Neoplasm
Active, not recruiting
Sickle Cell Disease (SCD) Bone Pain Study
Sickle Cell Disease, Sickle Cell Anemia

All Vertebral Compression Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radiofrequency Ablation of the Medial Branch Nerve as a Novel Treatment for Posterior Element Pain From Vertebral Compression Fractures
ClinicalTrials.gov ID: NCT03651804
Acronym / sponsor ID: 1198963
Conditions: Vertebral Compression Fracture, Facet Joint Pain
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Difficulty recruiting members
Enrolment: 0 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Study start: 10 Apr 2019 (actual)
Primary completion: 19 Dec 2023 (actual)
Study completion: 19 Dec 2023 (actual)
First posted: 29 Aug 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Control Group	Active comparator	Drug: Non-steroidal anti-inflammatory drugs, Drug: Bisphosphonates, Drug: Acetaminophen, Behavioral: Physical therapy, Drug: OpioidsThe 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.
Treatment Group	Active comparator	Procedure: Radiofrequency ablation of the medial branch nerves, Drug: Non-steroidal anti-inflammatory drugs, Drug: Bisphosphonates, Drug: Acetaminophen, Behavioral: Physical therapy, Drug: OpioidsThe 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.
Crossover Group	Active comparator	Procedure: Radiofrequency ablation of the medial branch nerves, Drug: Non-steroidal anti-inflammatory drugs, Drug: Bisphosphonates, Drug: Acetaminophen, Behavioral: Physical therapy, Drug: OpioidsThis 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.

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiofrequency ablation of the medial branch nervesAlso: RFA-MBBA 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.	Procedure or surgery	Crossover Group, Treatment Group
Non-steroidal anti-inflammatory drugsAlso: NSAIDSome 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.	Drug	Control Group, Crossover Group, Treatment Group
BisphosphonatesA class of drugs that prevent the loss of bone density and are used to treat osteoporosis and similar diseases.	Drug	Control Group, Crossover Group, Treatment Group
AcetaminophenAlso: TylenolA medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Commonly known as Tylenol.	Drug	Control Group, Crossover Group, Treatment Group
Physical therapyPhysical Therapy.	Behavioural	Control Group, Crossover Group, Treatment Group
OpioidsOpioids are narcotics that act on opioid receptors to produce morphine-like effects and medically they are primarily used for pain relief.	Drug	Control Group, Crossover Group, Treatment Group

Primary outcome

Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below.
Time frame: 0 weeks, 1 week, 12 weeks, 6 months
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.

3 secondary outcomes

Roland-Morris Disability Questionnaire at dedicated time frames listed below to assess change.
Time frame: 0 weeks, 1 week, 12 weeks, 6 months
QUALEFFO-41 (Quality of Life questionnaire) Scale at dedicated time frames listed below to assess change.
Time frame: 0 weeks, 1 week, 12 weeks, 6 months
Patient Health Questionnaire (PHQ-9) at dedicated Time Frames listed below.
Time frame: 0 weeks, 1 week, 12 weeks, 6 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
Background: PubMed 21337428Boonen 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.
Background: PubMed 19246088Wardlaw 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.
Background: PubMed 20701962Klazen 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.
Background: PubMed 19657121Buchbinder 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.
Background: PubMed 19657122Kallmes 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.
Background: PubMed 16983459Johnell 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.
Background: PubMed 27548307Solberg 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.
Background: PubMed 21044256Bogduk 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.
Background: PubMed 16361816Kim 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.
Background: PubMed 23705113Park 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.
Background: PubMed 26714695Im 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.
Background: PubMed 21029349Mitra 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.
Learn more or sign up for the study here!Link provided by the sponsor.
Individual participant dataSharing planned: Undecided

Related trials for Vertebral Compression Fracture

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Copenhaver, MD principal investigator

UC Davis Medical Center, Department of Anesthesiology and Pain Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Scale (VAS) of subjective pain at dedicated Time Frames listed below. (time frame: 0 weeks, 1 week, 12 weeks, 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03651804, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.