Cervical Paraspinal Muscle Twitching and Cervical Facet Radiofrequency Ablation Outcomes
NCT ID: NCT05450679
Last Updated: 2025-09-17
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
60 participants
OBSERVATIONAL
2022-09-13
2027-08-01
Brief Summary
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Detailed Description
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During the motor stimulation testing step, the pain physicians performing the procedure (e.g. attending, fellows, residents, etc.) will assess the presence or absence of cervical paraspinal muscle twitching by using a standardized grading scale (per radiofrequency electrode: 0 = no twitches observed or palpated; 1 = twitches palpated but not observed; 2 = twitches observed and palpated at 1-2 levels; 3 = twitches observed at \> 2 levels). A total score and a weighted score (total score divided by the number of radiofrequency lesion sites), will be recorded for each patient, and the RFA procedure will be completed per usual practice.
The interventional procedure used in this study (radiofrequency ablation) will be performed in the usual manner and as per "standard of care." The use of the grading scale described above to assess the presence/absence and magnitude of cervical paraspinal muscle twitching will be unique to this research study.
The investigators will also obtain the following data immediately pre-procedurally, from electronic health record review and also a standardized set of questionnaires provided to study participants:
* Information routinely obtained as standard practice: age, sex, average and worst neck pain score over the past week on numeric rating scale (NRS), percent pain relief from diagnostic block, duration of pain, inciting event, MRI findings if available, obesity (defined as BMI \> 30), smoking, co-existing pain conditions, co-existing psychiatric conditions, and potential sources of secondary gain (e.g. worker's compensation claim, ongoing litigation, etc.)
* Information obtained as part of the research study: Neck Disability Index (NDI) score, Athens Insomnia Scale (AIS) score, Hospital Anxiety and Depression Scale (HADS) scores.
At a 1-month post-procedural follow-up timepoint, the investigators will obtain the following data, from electronic health record review and also a standardized set of questionnaires provided to study participants:
* Information routinely obtained as standard practice: categorical binary outcome (positive outcome defined as \>/= 2-point decrease in average neck pain score coupled with PGIC score \>/= 5/7) analgesic medications and doses; status of medication reduction (yes or no); average and worst NRS pain score over the past week; description of any procedural complications
* Information obtained as part of the research study: NDI, AIS, and HADS scores; Patient Global Impression of Change Scale (PGIC) score
* Exiting the trial: patients may choose to exit the study at any time for any reason. A patient will exit the study to receive alternative care if the patient reports a PGIC score \<5 or \< 2-point reduction in average NRS pain score. This would indicate that the RFA treatment was unsuccessful.
At a 3-month post-procedural follow-up timepoint, the investigators will obtain the following data, from electronic health record review and also a standardized set of questionnaires provided to study participants:
* Information routinely obtained as standard practice: categorical binary outcome, analgesic medications and doses; status of medication reduction (yes or no); average and worst NRS pain score over the past week; description of any procedural complications
* Information obtained as part of the research study: NDI, AIS, and HADS scores; Patient Global Impression of Change Scale (PGIC) score on 7-point Likert scale
* Exiting the trial: patients may choose to exit the study at any time for any reason. A patient will exit the study to receive alternative treatment if the patient reports a PGIC score \<5 or \< 2-point reduction in average NRS pain score. This would indicate that the analgesic and functional benefit of the RFA procedure has now been exhausted.
At a 6-month post-procedural follow-up timepoint, the investigators will obtain the following data, from electronic health record review and also a standardized set of questionnaires provided to study participants:
* Information routinely obtained as standard practice: binary categorical outcome, analgesic medications and doses; status of medication reduction (yes or no); average and worst NRS pain score over the past week; description of any procedural complications
* Information obtained as part of the research study: NDI, AIS, and HADS scores; Patient Global Impression of Change Scale (PGIC) score
* Exiting the trial: All patients who remain in the study will exit at 6 months.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cervical Radiofrequency Ablation (RFA)-treated group
Only patients who have already been deemed candidates by their primary pain physician for cervical RFA will be recruited to the study. During the cervical RFA procedure, all patients will undergo sensory and motor stimulation testing prior to receiving radiofrequency lesioning, which is a standard and recommended practice.
Cervical Radiofrequency Ablation (RFA)
During the cervical RFA procedure, all patients will undergo sensory and motor stimulation testing prior to receiving radiofrequency lesioning, which is a standard and recommended practice.
During the motor stimulation testing step, the pain physicians performing the procedure will assess the presence or absence of cervical paraspinal muscle twitching by using a standardized grading scale (per radiofrequency electrode: 0 = no twitches observed or palpated; 1 = twitches palpated but not observed; 2 = twitches observed and palpated at 1-2 levels; 3 = twitches observed at \> 2 levels). A total score and a weighted score (total score divided by the number of radiofrequency lesion sites), will be recorded for each patient, and the RFA procedure will be completed per usual practice.
RFAs will be performed in the usual manner and as per "standard of care." Providers will not use any new or experimental devices to perform the RFA.
Interventions
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Cervical Radiofrequency Ablation (RFA)
During the cervical RFA procedure, all patients will undergo sensory and motor stimulation testing prior to receiving radiofrequency lesioning, which is a standard and recommended practice.
During the motor stimulation testing step, the pain physicians performing the procedure will assess the presence or absence of cervical paraspinal muscle twitching by using a standardized grading scale (per radiofrequency electrode: 0 = no twitches observed or palpated; 1 = twitches palpated but not observed; 2 = twitches observed and palpated at 1-2 levels; 3 = twitches observed at \> 2 levels). A total score and a weighted score (total score divided by the number of radiofrequency lesion sites), will be recorded for each patient, and the RFA procedure will be completed per usual practice.
RFAs will be performed in the usual manner and as per "standard of care." Providers will not use any new or experimental devices to perform the RFA.
Eligibility Criteria
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Inclusion Criteria
* Cervical facet arthropathy based on history and physical exam (e.g. axial cervical neck pain, paraspinal tenderness, no pain referral below the ipsilateral shoulder)
* Radiologic evidence of cervical pathology consistent with symptoms if MRI is available
* Pain duration of greater than 3 months
* Obtained 50% or greater pain relief from at least 1 diagnostic cervical medial branch block of the identical medial branch nerves targeted for RFA
Exclusion Criteria
* Signs or symptoms of cervical myelopathy
* Signs or symptoms of cervical radiculitis/radiculopathy
* Allergic reactions to local anesthetics
* Serious psychiatric disorder (e.g. uncontrolled or refractory depression) that might preclude optimal outcome
* Poorly controlled medical condition (e.g. pacemaker that cannot be switched off, unstable angina)
* Pregnancy
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Eric Wang, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
Countries
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References
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GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.
Aprill C, Bogduk N. The prevalence of cervical zygapophyseal joint pain. A first approximation. Spine (Phila Pa 1976). 1992 Jul;17(7):744-7. doi: 10.1097/00007632-199207000-00003.
Manchikanti L, Singh V, Rivera J, Pampati V. Prevalence of cervical facet joint pain in chronic neck pain. Pain Physician. 2002 Jul;5(3):243-9.
Schaerer JP. Radiofrequency facet rhizotomy in the treatment of chronic neck and low back pain. Int Surg. 1978 Sep-Dec;63(6):53-9.
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.
Huygen F, Kallewaard JW, van Tulder M, Van Boxem K, Vissers K, van Kleef M, Van Zundert J. "Evidence-Based Interventional Pain Medicine According to Clinical Diagnoses": Update 2018. Pain Pract. 2019 Jul;19(6):664-675. doi: 10.1111/papr.12786. Epub 2019 May 2.
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. Reg Anesth Pain Med. 2022 Jan;47(1):3-59. doi: 10.1136/rapm-2021-103031. Epub 2021 Nov 11.
Lord SM, McDonald GJ, Bogduk N. Percutaneous Radiofrequency Neurotomy of the Cervical Medial Branches. Neurosurgery Quarterly. 1998;8(4):288-308. doi:10.1097/00013414-199812000-00004
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.
Manchikanti L, Sanapati MR, Pampati V, Soin A, Atluri S, Kaye AD, Subramanian J, Hirsch JA. Update of Utilization Patterns of Facet Joint Interventions in Managing Spinal Pain from 2000 to 2018 in the US Fee-for-Service Medicare Population. Pain Physician. 2020 Mar;23(2):E133-E149.
International Spine Intervention Society. ISIS Practice Guidelines for Spinal Diagnostic and Treatment Procedures: 2nd Edition.; 2013. https://books.google.com/books/about/ISIS_Practice_Guidelines_for_Spinal_Diag.html?hl=&id=ikWhoAEACAAJ
Cohen SP, Strassels SA, Kurihara C, Lesnick IK, Hanling SR, Griffith SR, Buckenmaier CC 3rd, Nguyen C. Does sensory stimulation threshold affect lumbar facet radiofrequency denervation outcomes? A prospective clinical correlational study. Anesth Analg. 2011 Nov;113(5):1233-41. doi: 10.1213/ANE.0b013e31822dd379. Epub 2011 Sep 14.
Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine (Phila Pa 1976). 2000 May 15;25(10):1270-7. doi: 10.1097/00007632-200005150-00012.
Koh JC, Kim DH, Lee YW, Choi JB, Ha DH, An JW. Relationship between paravertebral muscle twitching and long-term effects of radiofrequency medial branch neurotomy. Korean J Pain. 2017 Oct;30(4):296-303. doi: 10.3344/kjp.2017.30.4.296. Epub 2017 Sep 29.
Other Identifiers
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IRB00323880
Identifier Type: -
Identifier Source: org_study_id
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