Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
NCT Number: NCT05450679
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.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Baltimore, Maryland, 21287, United States
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 3 months
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
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
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
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 3 months
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 6 months
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 1 month
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 3 months
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 6 months
Pain scores measured on 0-10 numeric rating scale (NRS)
Time frame: 1 month
Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function)
Time frame: 3 months
Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function)
Time frame: 6 months
Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function)
Time frame: 1 month
Athens Insomnia Scale (AIS) score (0-24, with higher scores indicate greater dysfunction)
Time frame: 3 months
Athens Insomnia Scale (AIS) score (0-24, with higher scores indicate greater dysfunction)
Time frame: 6 months
Athens Insomnia Scale (AIS) score (0-24, with higher scores indicate greater dysfunction)
Time frame: 1 month
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
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
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
Defined as cessation of a non-opioid analgesic or > 20% decrease in pre-existing opioid consumption
Time frame: 3 months
Defined as cessation of a non-opioid analgesic or > 20% decrease in pre-existing opioid consumption
Time frame: 6 months
Defined as cessation of a non-opioid analgesic or > 20% decrease in pre-existing opioid consumption
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)
Any reported adverse events or complications directly related to the cervical radiofrequency ablation (RFA) procedure.
Johns Hopkins University
Other
The Predictive Value of Cervical Paraspinal Muscle Twitching During Motor Stimulation Testing on Cervical Facet Joint Radiofrequency Ablation Outcomes
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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