Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical Radiofrequency Ablation (RFA) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Wang, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27733282 | Background | 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. | |
| 1502636 |
Not provided
Not provided
There is not a plan to make individual participant data available.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D019547 | Neck Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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." | 6 months |
| Average neck pain score | Pain scores measured on 0-10 numeric rating scale (NRS) | 1 month |
| Average neck pain score | Pain scores measured on 0-10 numeric rating scale (NRS) | 3 months |
| Average neck pain score | Pain scores measured on 0-10 numeric rating scale (NRS) | 6 months |
| Worst neck pain score | Pain scores measured on 0-10 numeric rating scale (NRS) | 1 month |
| Worst neck pain score | Pain scores measured on 0-10 numeric rating scale (NRS) | 3 months |
| Worst neck pain score | Pain scores measured on 0-10 numeric rating scale (NRS) | 6 months |
| Functional outcome as measured using the Neck disability index (NDI) | Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function) | 1 month |
| Functional outcome as measured using the Neck disability index (NDI) | Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function) | 3 months |
| Functional outcome as measured using the Neck disability index (NDI) | Neck disability index (NDI) score (0-100%, higher numbers indicate poorer function) | 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) | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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 | 6 months |
| Procedural complications | Any reported adverse events or complications directly related to the cervical radiofrequency ablation (RFA) procedure. | Any time point up to the 6-month post-procedural follow-up visit or up to the patient exiting the trial (whichever occurs first) |
| 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. |
| 16902649 | Background | 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. |
| 155664 | Background | Schaerer JP. Radiofrequency facet rhizotomy in the treatment of chronic neck and low back pain. Int Surg. 1978 Sep-Dec;63(6):53-9. |
| 8929263 | Background | 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. |
| 30957944 | Background | 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. |
| 34764220 | Background | 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. |
| Background | 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 |
| 22458772 | Background | 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. |
| 32214289 | Background | 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. |
| Background | 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 |
| 21918166 | Background | 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. |
| 10806505 | Background | 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. |
| 29123625 | Background | 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. |