An observational study in Cervical Facet Joint Pain, Chronic Pain and Neck Pain, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Johns Hopkins University · Observational
The investigators aim to determine whether cervical paravertebral muscle twitching during motor testing as part of performing cervical RFAs is associated with a greater likelihood of treatment success, and greater magnitude or duration of analgesia. The investigators propose a straightforward grading scale based on visual and tactile information readily available during RFA procedures as part of routine practice (per radiofrequency electrode: 0 = no twitches palpated or observed; 1 = twitches palpated but not observed; 2 = twitches palpated and observed at 1-2 levels; 3= twitches palpated and observed at >2 levels). If a higher weighted score (total score divided by number of radiofrequency lesion sites) correlates with a greater likelihood of treatment success, or magnitude or duration of analgesia following cervical RFA, cervical paraspinal muscle twitching may serve as a readily obtainable prognostic factor (marker) for effectiveness.
Approximately 60 patients with cervical facet arthropathy who are undergoing cervical radiofrequency ablation (RFA) will be recruited for this study. Only patients who have already been deemed candidates by their primary pain physician for cervical RFA (e.g. > 50% relief from a diagnostic cervical medial branch block) will be recruited. 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. The investigators will align the electrodes to optimize sensory testing.
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:
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:
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:
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:
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This study's enrollment of 69 is below the median of 126 across 688 observational studies indexed under Chronic Pain.
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Only patients who have already been deemed candidates by their primary pain physician for a cervical radiofrequency ablation (RFA) (e.g. >/= 50% relief from a diagnostic cervical medial branch block) will be recruited.
Exclusion Criteria:
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.
Procedure: 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.
Categorical number of participants with treatment success or failure
Definition of success: a \>/= 2-point decrease in average neck pain (measured over the past week) coupled with a score of \>/= 5/7 on a patient global impression of change (PGIC) scale where 1= "no change or worsened symptoms", 5= "moderately better, a slight but noticeable change", and 7= "a great deal better."
Time frame: 3 months
Categorical number of participants with treatment success or failure
Definition of success: a \>/= 2-point decrease in average neck pain (measured over the past week) coupled with a score of \>/= 5/7 on a patient global impression of change (PGIC) scale where 1= "no change or worsened symptoms", 5= "moderately better, a slight but noticeable change", and 7= "a great deal better."
Time frame: 1 month
Categorical number of participants with treatment success or failure
Definition of success: a \>/= 2-point decrease in average neck pain (measured over the past week) coupled with a score of \>/= 5/7 on a patient global impression of change (PGIC) scale where 1= "no change or worsened symptoms", 5= "moderately better, a slight but noticeable change", and 7= "a great deal better."
Time frame: 6 months
Average neck pain score
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 1 month
Average neck pain score
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 3 months
Average neck pain score
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 6 months
Worst neck pain score
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 1 month
Worst neck pain score
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 3 months
Worst neck pain score
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 6 months
Functional outcome as measured using the Neck disability index (NDI)
Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function)
Time frame: 1 month
Functional outcome as measured using the Neck disability index (NDI)
Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function)
Time frame: 3 months
Functional outcome as measured using the Neck disability index (NDI)
Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function)
Time frame: 6 months
Sleep quality as assessed by the Athens Insomnia Scale (AIS)
Athens Insomnia Scale (AIS) score (0-24, with higher scores indicate greater dysfunction)
Time frame: 1 month
Sleep quality as assessed by the Athens Insomnia Scale (AIS)
Athens Insomnia Scale (AIS) score (0-24, with higher scores indicate greater dysfunction)
Time frame: 3 months
Sleep quality as assessed by the Athens Insomnia Scale (AIS)
Athens Insomnia Scale (AIS) score (0-24, with higher scores indicate greater dysfunction)
Time frame: 6 months
Mood and anxiety as assessed by the Hospital anxiety and depression scale (HADS)
Hospital anxiety and depression scale (HADS) score (Depression and anxiety scored from 0-21 with higher scores indicating greater depression and anxiety)
Time frame: 1 month
Mood and anxiety as assessed by the Hospital anxiety and depression scale
Hospital anxiety and depression scale (HADS) score (Depression and anxiety scored from 0-21 with higher scores indicating greater depression and anxiety)
Time frame: 3 months
Mood and anxiety as assessed by the Hospital anxiety and depression scale
Hospital anxiety and depression scale (HADS) score (Depression and anxiety scored from 0-21 with higher scores indicating greater depression and anxiety)
Time frame: 6 months
Medication reduction as assessed by follow-up visit or telephone call, and Prescription Drug Monitoring Program data review
Defined as cessation of a non-opioid analgesic or \> 20% decrease in pre-existing opioid consumption
Time frame: 1 month
Medication reduction as assessed by follow-up visit or telephone call, and Prescription Drug Monitoring Program data review
Defined as cessation of a non-opioid analgesic or \> 20% decrease in pre-existing opioid consumption
Time frame: 3 months
Medication reduction as assessed by follow-up visit or telephone call, and Prescription Drug Monitoring Program data review
Defined as cessation of a non-opioid analgesic or \> 20% decrease in pre-existing opioid consumption
Time frame: 6 months
Procedural complications
Any reported adverse events or complications directly related to the cervical radiofrequency ablation (RFA) procedure.
Time frame: Any time point up to the 6-month post-procedural follow-up visit or up to the patient exiting the trial (whichever occurs first)
Plan to share: No — There is not a plan to make individual participant data available.
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