- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07535515
Radiofrequency Versus Cervical Fusion for Chronic Whiplash (WHIPLASH-RFvsA)
Comparative Effectiveness of Cervical Zygapophyseal Joint Radiofrequency Versus Anterior Cervical Discectomy and Fusion in Chronic Post-Traumatic Whiplash: A Retrospective Cohort Study
Chronic neck pain after whiplash injury is a common and disabling condition that can significantly affect quality of life, daily activities, and psychological well-being. In some patients, pain persists for months or years despite conservative treatments, leading to consideration of more invasive therapeutic options. Two commonly used treatments in selected patients are cervical zygapophyseal (facet) joint radiofrequency and anterior cervical discectomy and fusion (ACDF), but their comparative long-term outcomes in routine clinical practice are not well defined.
This study aims to compare the clinical, functional, and psychological outcomes of patients with chronic post-traumatic cervical whiplash who were treated either with cervical medial branch radiofrequency or with anterior cervical discectomy and fusion. The study uses a retrospective observational design based on the review of medical records from a tertiary hospital over a 20-year period.
Adult patients diagnosed with chronic post-traumatic whiplash and treated between 2005 and 2025 are included. All treatments were performed as part of usual clinical care and were not assigned for research purposes. Data collected include patient characteristics, injury mechanism, type of treatment received, pain intensity, functional disability, psychological symptoms, need for repeat procedures or additional surgery, and clinical follow-up information.
The primary objective is to compare pain relief between the two treatment groups. Secondary objectives include comparison of functional recovery, duration of treatment benefit, recurrence of pain, psychological symptoms, need for further interventions, and return to daily activities or work.
By analyzing long-term real-world data, this study seeks to improve understanding of the relative effectiveness of cervical radiofrequency and surgical fusion for chronic whiplash pain, helping clinicians and patients make more informed treatment decisions. No new interventions are performed as part of this study, and all data are analyzed anonymously.
Study Overview
Status
Detailed Description
Chronic post-traumatic cervical whiplash is a frequent cause of persistent neck pain, functional disability, and psychological distress following acceleration-deceleration injuries. Although many patients recover with conservative management, a substantial proportion develop chronic symptoms lasting months or years. In these cases, identifying the predominant pain generator is essential for guiding treatment.
Previous studies have shown that the cervical zygapophyseal (facet) joints are a common source of chronic pain after whiplash injury, leading to the development of targeted interventional strategies. Cervical medial branch radiofrequency is a minimally invasive technique designed to interrupt nociceptive input from the facet joints and has been associated with meaningful pain relief and functional improvement in appropriately selected patients. In parallel, anterior cervical discectomy and fusion (ACDF) has been used in selected patients with persistent post-traumatic neck pain, particularly when structural abnormalities are identified. However, ACDF is a more invasive intervention, associated with greater treatment burden and potential long-term consequences, and its role in isolated chronic whiplash without radiculopathy or myelopathy remains debated.
Despite the widespread clinical use of both approaches, there is limited evidence directly comparing their real-world effectiveness in patients with chronic post-traumatic whiplash. The present study addresses this gap by examining long-term outcomes in a large, single-center cohort treated as part of routine clinical practice over a 20-year period.
This study is designed as a retrospective observational cohort analysis conducted at a tertiary care hospital. Patients are categorized according to the definitive treatment they received as part of standard clinical care: cervical medial branch radiofrequency or anterior cervical discectomy and fusion. Treatment decisions were based on clinical judgment and available diagnostic information and were not determined by any research protocol.
Clinical data are obtained through review of electronic medical records and procedural documentation. The analysis focuses on comparative evaluation of outcomes between treatment groups, with attention to differences in patient characteristics and clinical context. Multivariable statistical methods, and where appropriate propensity-based adjustment, are used to account for potential confounding factors inherent to observational comparative research.
Because this is a retrospective observational study based on routine clinical care, all analyses are exploratory and hypothesis-generating in nature. By leveraging long-term real-world clinical data, this study seeks to improve understanding of the relative benefits and limitations of minimally invasive versus surgical treatment strategies for chronic post-traumatic whiplash, supporting more informed and evidence-based clinical decision-making.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Valencia
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Valencia, Valencia, Spain, 46015
- Consorcio Hospital General Universitario de Valencia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- Adults aged 18 years or older at the time of treatment.
- Clinical diagnosis of chronic post-traumatic cervical whiplash, with symptoms persisting for at least 3 months following the traumatic event.
- Cervical pain attributed to a traumatic acceleration-deceleration mechanism (whiplash injury).
- Treatment with either:
- cervical medial branch radiofrequency, or
- anterior cervical discectomy and fusion performed as part of routine clinical care.
Exclusion Criteria
- Cervical pain primarily attributable to non-traumatic conditions, including degenerative cervical disease, inflammatory disorders, neoplastic disease, infection, radiculopathy, or cervical myelopathy.
- History of previous cervical spine surgery before the index treatment, which could interfere with the assessment of treatment outcomes.
- Patients who received both cervical radiofrequency and anterior cervical discectomy and fusion for the same clinical episode of whiplash-related pain.
- Cervical procedures performed outside the Hospital General Universitario de Valencia or without verifiable technical documentation in the medical record.
Insufficient clinical documentation to confirm the diagnosis of post-traumatic whiplash or to evaluate pain, functional, or psychological outcomes after treatment.
- Absence of clinical follow-up data after the index treatment.
- Age under 18 years at the time of treatment. Availability of clinical follow-up data after treatment that allows assessment of pain and/or functional outcomes.
Treatment performed at the Hospital General Universitario de Valencia between 2005 and 2025.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cervical Medial Branch Radiofrequency
Patients with chronic post-traumatic cervical whiplash who were treated with cervical zygapophyseal (facet) joint medial branch radiofrequency as part of routine clinical care.
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Anterior Cervical Discectomy and Fusion (ACDF)
Patients with chronic post-traumatic cervical whiplash who were treated with anterior cervical discectomy and fusion as part of routine clinical care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Relief After Treatment
Time Frame: From baseline (pre-treatment) to last documented clinical follow-up, assessed up to 12 months after treatment.
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Change in neck pain intensity following treatment measured using the Visual Analogue Scale for pain (VAS; 0-10 scale, where 0 indicates no pain and 10 indicates worst imaginable pain).
Pain relief will be evaluated as absolute change from baseline and as the proportion of patients achieving a clinically meaningful reduction of at least 50% from baseline.
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From baseline (pre-treatment) to last documented clinical follow-up, assessed up to 12 months after treatment.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Functional Disability of the Neck
Time Frame: From baseline to last documented clinical follow-up, assessed up to 12 months after treatment.
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Functional disability assessed using the Neck Disability Index (NDI; 0-50 points, where higher scores indicate greater disability), when available in the medical record.
Outcomes will be analyzed as change from baseline and overall functional improvement after treatment.
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From baseline to last documented clinical follow-up, assessed up to 12 months after treatment.
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Duration of Pain Relief
Time Frame: From date of index treatment to documented recurrence of pain or last clinical follow-up, assessed up to 24 months after treatment.
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Time from index treatment to recurrence of neck pain defined as a return to at least 50% of baseline pain intensity, based on clinical records.
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From date of index treatment to documented recurrence of pain or last clinical follow-up, assessed up to 24 months after treatment.
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Need for Additional Interventions
Time Frame: From treatment to additional intervention or last documented follow-up, assessed up to 24 months.
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Proportion of patients requiring repeat cervical radiofrequency procedures, revision surgery, or additional cervical interventions due to recurrence or persistence of symptoms.
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From treatment to additional intervention or last documented follow-up, assessed up to 24 months.
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Psychological Symptoms Related to Chronic Pain
Time Frame: From baseline to last documented clinical follow-up, assessed up to 12 months after treatment.
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Presence and evolution of psychological symptoms assessed using standardized instruments such as the Hospital Anxiety and Depression Scale (HADS; 0-21 per subscale, where higher scores indicate worse symptoms) or the Symptom Checklist-90-Revised (SCL-90-R; higher scores indicate greater psychological distress), when available, or through structured clinical documentation.
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From baseline to last documented clinical follow-up, assessed up to 12 months after treatment.
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Return to Daily Activities or Work
Time Frame: From treatment to documented return to work or resumption of usual daily activities, assessed up to 12 months after treatment.
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Functional recovery assessed through clinical documentation of return to work or resumption of usual daily activities after treatment.
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From treatment to documented return to work or resumption of usual daily activities, assessed up to 12 months after treatment.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vicente Vanaclocha Vanaclocha, MD PhD, University of Valencia
Publications and helpful links
General Publications
- 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.
- Barnsley L. Percutaneous radiofrequency neurotomy for chronic neck pain: outcomes in a series of consecutive patients. Pain Med. 2005 Jul-Aug;6(4):282-6. doi: 10.1111/j.1526-4637.2005.00047.x.
- McDonald GJ, Lord SM, Bogduk N. Long-term follow-up of patients treated with cervical radiofrequency neurotomy for chronic neck pain. Neurosurgery. 1999 Jul;45(1):61-7; discussion 67-8. doi: 10.1097/00006123-199907000-00015.
- MacVicar J, Borowczyk JM, MacVicar AM, Loughnan BM, Bogduk N. Cervical medial branch radiofrequency neurotomy in New Zealand. Pain Med. 2012 May;13(5):647-54. doi: 10.1111/j.1526-4637.2012.01351.x. Epub 2012 Mar 28.
- Smith AD, Jull G, Schneider G, Frizzell B, Hooper RA, Dunne-Proctor R, Sterling M. Cervical radiofrequency neurotomy reduces psychological features in individuals with chronic whiplash symptoms. Pain Physician. 2014 May-Jun;17(3):265-74.
- Smith AD, Jull G, Schneider GM, Frizzell B, Hooper RA, Sterling M. Modulation of Cervical Facet Joint Nociception and Pain Attenuates Physical and Psychological Features of Chronic Whiplash: A Prospective Study. PM R. 2015 Sep;7(9):913-921. doi: 10.1016/j.pmrj.2015.03.014. Epub 2015 Mar 21.
- Alomari A, Ferreira-Dos-Santos G, Singh M, Burnham T, Cao X, McCormick Z, Flamer D, Kumar P, Hoydonckx Y, Khan JS, Tumber PS, Alvares D, Bhatia A. End-on versus parallel radiofrequency lesioning for neurotomy of the cervical medial branch nerves: a study protocol of a prospective, randomized, double-blind clinical trial: the "EndPaRL" study. Trials. 2023 Nov 11;24(1):721. doi: 10.1186/s13063-023-07752-9.
- Hurley RW, Adams MCB, Barad M, Bhaskar A, Bhatia A, Chadwick A, Deer TR, Hah J, Hooten WM, Kissoon NR, Lee DW, Mccormick Z, Moon JY, Narouze S, Provenzano DA, Schneider BJ, van Eerd M, Van Zundert J, Wallace MS, Wilson SM, Zhao Z, Cohen SP. Consensus practice guidelines on interventions for cervical spine (facet) joint pain from a multispecialty international working group. Pain Med. 2021 Nov 26;22(11):2443-2524. doi: 10.1093/pm/pnab281.
- Manchikanti L, Knezevic NN, Knezevic E, Abdi S, Sanapati MR, Soin A, Wargo BW, Navani A, Atluri S, Gharibo CG, Simopoulos TT, Kosanovic R, Abd-Elsayed A, Kaye AD, Hirsch JA. A Systematic Review and Meta-analysis of the Effectiveness of Radiofrequency Neurotomy in Managing Chronic Neck Pain. Pain Ther. 2023 Feb;12(1):19-66. doi: 10.1007/s40122-022-00455-0. Epub 2022 Nov 24.
- Yen CY, Lin SM, Chen HY, Wang SW, Tsai YD, Chye CL, Chen TY, Wang HK, Wang KW. Sagittal alignment to predict efficiency in pulsed radiofrequency for cervical facet joint pain. Sci Rep. 2024 Nov 19;14(1):28563. doi: 10.1038/s41598-024-79181-w.
- Burnham R, Trow R, Trow J, Smith A, Burnham T. Can ultrasound-guided medial branch blocks be used to select patients for cervical facet joint radiofrequency neurotomy? A matched retrospective cohort validation study. Pain Med. 2024 Nov 1;25(11):671-674. doi: 10.1093/pm/pnae054.
- Sherwood D, Berlin E, Epps A, Gardner J, Schneider BJ. Cervical medial branch block progression to radiofrequency neurotomy: A retrospective clinical audit. N Am Spine Soc J. 2021 Nov 3;8:100091. doi: 10.1016/j.xnsj.2021.100091. eCollection 2021 Dec.
- Shin WR, Kim HI, Shin DG, Shin DA. Radiofrequency neurotomy of cervical medial branches for chronic cervicobrachialgia. J Korean Med Sci. 2006 Feb;21(1):119-25. doi: 10.3346/jkms.2006.21.1.119.
- Sapir DA, Gorup JM. Radiofrequency medial branch neurotomy in litigant and nonlitigant patients with cervical whiplash: a prospective study. Spine (Phila Pa 1976). 2001 Jun 15;26(12):E268-73. doi: 10.1097/00007632-200106150-00016.
- Prushansky T, Pevzner E, Gordon C, Dvir Z. Cervical radiofrequency neurotomy in patients with chronic whiplash: a study of multiple outcome measures. J Neurosurg Spine. 2006 May;4(5):365-73. doi: 10.3171/spi.2006.4.5.365.
- Wallis BJ, Lord SM, Bogduk N. Resolution of psychological distress of whiplash patients following treatment by radiofrequency neurotomy: a randomised, double-blind, placebo-controlled trial. Pain. 1997 Oct;73(1):15-22. doi: 10.1016/s0304-3959(97)00060-2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIm PI 28-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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