NCT07535515

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
20.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

20.9 years

First QC Date

April 7, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

WhiplashCervical Facet Joint PainCervical RadiofrequencyAnterior Cervical Discectomy and FusionChronic Neck PainPost-Traumatic Neck PainRadiofrequency NeurotomyComparative EffectivenessRetrospective Cohort

Outcome Measures

Primary Outcomes (1)

  • Pain Relief After Treatment

    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.

    From baseline (pre-treatment) to last documented clinical follow-up, assessed up to 12 months after treatment.

Secondary Outcomes (5)

  • Functional Disability of the Neck

    From baseline to last documented clinical follow-up, assessed up to 12 months after treatment.

  • Duration of Pain Relief

    From date of index treatment to documented recurrence of pain or last clinical follow-up, assessed up to 24 months after treatment.

  • Need for Additional Interventions

    From treatment to additional intervention or last documented follow-up, assessed up to 24 months.

  • Psychological Symptoms Related to Chronic Pain

    From baseline to last documented clinical follow-up, assessed up to 12 months after treatment.

  • Return to Daily Activities or Work

    From treatment to documented return to work or resumption of usual daily activities, assessed up to 12 months after treatment.

Study Arms (2)

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.

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of adult patients with chronic post-traumatic cervical whiplash who were treated at a tertiary care hospital between 2005 and 2025. Eligible patients are those aged 18 years or older who developed persistent neck pain following a traumatic acceleration-deceleration injury and whose symptoms persisted for at least three months. All patients received either cervical medial branch radiofrequency or anterior cervical discectomy and fusion as part of routine clinical care, based on standard clinical indications. The population includes both male and female patients and represents a real-world cohort managed in specialized clinical practice. Only patients with sufficient clinical documentation and available follow-up data to assess pain, functional outcomes, and treatment durability are included.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consorcio Hospital General Universitario de Valencia

Valencia, Valencia, 46015, Spain

Location

Related Publications (16)

  • 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.

    PMID: 37951900BACKGROUND
  • 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.

    PMID: 34788462BACKGROUND
  • 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.

    PMID: 36422818BACKGROUND
  • 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.

    PMID: 39557962BACKGROUND
  • 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.

    PMID: 38937279BACKGROUND
  • 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.

    PMID: 35141655BACKGROUND
  • 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.

    PMID: 16479077BACKGROUND
  • 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.

    PMID: 22458772BACKGROUND
  • 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.

    PMID: 11426167BACKGROUND
  • 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.

    PMID: 16703903BACKGROUND
  • 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.

    PMID: 24850108BACKGROUND
  • 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.

    PMID: 9414052BACKGROUND
  • 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.

    PMID: 25805617BACKGROUND
  • 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.

    PMID: 10414567BACKGROUND
  • 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: 8929263BACKGROUND
  • 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.

    PMID: 16083457BACKGROUND

MeSH Terms

Conditions

Whiplash Injuries

Condition Hierarchy (Ancestors)

Neck InjuriesWounds and Injuries

Study Officials

  • Vicente Vanaclocha Vanaclocha, MD PhD

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

April 7, 2026

First Posted

April 17, 2026

Study Start

January 1, 2005

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations