Cervical Paraspinal Muscle Twitching and Cervical Facet Radiofrequency Ablation Outcomes

NCT05450679 | Active Not Recruiting

• 1 other identifier: IRB00323880
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Facet Joint Pain; Chronic Pain; Neck Pain

Keywords

facet arthropathy; cervicalgia; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (21)

• Categorical number of participants with treatment success or failure

  1 month

• Categorical number of participants with treatment success or failure

  6 months

• Average neck pain score

  1 month

• Average neck pain score

  3 months

• Average neck pain score

  6 months

Study Arms (1)

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.

Procedure: Cervical Radiofrequency Ablation (RFA)

Interventions

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.

Cervical Radiofrequency Ablation (RFA)-treated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (14)

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• 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.

  PMID: 16902649 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.

  PMID: 155664 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.

  PMID: 8929263 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.

  PMID: 30957944 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.

  PMID: 34764220 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

  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.

  PMID: 22458772 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.

  PMID: 32214289 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

  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.

  PMID: 21918166 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.

  PMID: 10806505 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.

  PMID: 29123625 BACKGROUND

MeSH Terms

Conditions

Chronic Pain; Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Wang, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2022
• First Posted: July 11, 2022
• Study Start: September 13, 2022
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)