60 Participants Needed

Cervical Paraspinal Muscle Twitching and Cervical Facet Radiofrequency Ablation Outcomes

EW
SC
Overseen BySteven Cohen, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

EW

Eric Wang, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

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
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cervical radiofrequency ablation (RFA) with sensory and motor stimulation testing

Immediate (procedure day)
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month
1 visit (in-person)

Extended Follow-up

Participants continue to be monitored for long-term outcomes and effectiveness

6 months
2 visits (in-person)

Treatment Details

Interventions

  • Cervical Radiofrequency Ablation (RFA)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Cervical Radiofrequency Ablation (RFA)-treated groupExperimental Treatment1 Intervention
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.

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Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+
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