The Predictive Value of Cervical Paraspinal Muscle Twitching During Motor Stimulation Testing on Cervical Facet Joint Radiofrequency Ablation Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Categorical number of participants with treatment success or failure
研究概览
简要总结
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.
详细描述
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:
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •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
排除标准
- •Untreated coagulopathy
- •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
研究组 & 干预措施
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.
干预措施: Cervical Radiofrequency Ablation (RFA) (Procedure)
结局指标
主要结局
Categorical number of participants with treatment success or failure
时间窗: 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."
次要结局
- Average neck pain score(6 months)
- Medication reduction as assessed by follow-up visit or telephone call, and Prescription Drug Monitoring Program data review(6 months)
- Categorical number of participants with treatment success or failure(6 months)
- Sleep quality as assessed by the Athens Insomnia Scale (AIS)(6 months)
- Mood and anxiety as assessed by the Hospital anxiety and depression scale (HADS)(1 month)
- Mood and anxiety as assessed by the Hospital anxiety and depression scale(6 months)
- Worst neck pain score(6 months)
- Functional outcome as measured using the Neck disability index (NDI)(6 months)
- Procedural complications(Any time point up to the 6-month post-procedural follow-up visit or up to the patient exiting the trial (whichever occurs first))
- Categorical number of participants with treatment success or failure(1 month)
- Average neck pain score(1 month)
- Average neck pain score(3 months)
- Worst neck pain score(1 month)
- Worst neck pain score(3 months)
- Functional outcome as measured using the Neck disability index (NDI)(1 month)
- Functional outcome as measured using the Neck disability index (NDI)(3 months)
- Sleep quality as assessed by the Athens Insomnia Scale (AIS)(1 month)
- Sleep quality as assessed by the Athens Insomnia Scale (AIS)(3 months)
- Mood and anxiety as assessed by the Hospital anxiety and depression scale(3 months)
- Medication reduction as assessed by follow-up visit or telephone call, and Prescription Drug Monitoring Program data review(1 month)
- Medication reduction as assessed by follow-up visit or telephone call, and Prescription Drug Monitoring Program data review(3 months)