PDCN for Treatment of Cervical Vertigo

Study Overview
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Brief Summary
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This is a prospective, randomized controlled trial in a single center to explore the effectiveness and safety of percutaneous disc decompression with coblation nucleoplasty (PDCN) for the treatment of cervicogenic dizziness.

Detailed Description
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Vertigo ranks among the most common complaints in medicine and have a considerable personal impact, affecting 15-35% of the general population at some point in their lives. The combination of neck disorders with vertigo or dizziness was formally coined cervical vertigo by Ryan and Cope in 1955. The precise incidence of cervical vertigo is controversial but it is estimated that 20-58% of patients who sustain closed-head injuries or whiplash experience late onset symptoms of dizziness, vertigo and disequilibrium. The treatment option of cervical vertigo is versatile and challenging. Surgical intervention is recommended when the patient is a good candidate. Plasma-mediated ablation using the Coblation Spine-Wand device has been used for several years to perform spine disc decompression. However, there is no short and long-term report of percutaneous disc decompression with coblation nucleoplasty (PDCN) for treatment of cervical vertigo, and complications observed with this procedure have not been reported yet. In the retrospective observational study (unpublished data), the investigators found that PDCN was effective for reducing cervicogenic dizziness, a disabling and persistent problem, in the long term. A mean effective rate of 94.6% (70 of the 74 patients) one week after surgery and 90.6% (67 of the 74 patients) at the last follow-up (1 year to 8 years and 3 months). Good to excellent results were attained in 85.1% (63 of the 74 patients) of these patients one week after PDCN and achieved in 75.7% (56 of the 74 patients) at the last follow-up (p<0.0001). Recently, a randomized trial had proven that manual therapy had long-term beneficial effects in the treatment of chronic cervicogenic dizziness. This study aims to conduct a randomized controlled trial to investigate both of its short term and long term effectiveness and safety in prospective fashion comparing with manual therapy. Participants will be randomized and allocated to either PDCN group or manual therapy group with 1:1 ratio. All the patients had recurring symptom of dizziness over three months and conservative treatment applied for at least three weeks and failed.

Official Title
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Therapeutic Effects and Safety of Percutaneous Disc Decompression With Coblation Nucleoplasty in Cervical Vertigo

Conditions
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Cervical Vertigo

Intervention / Treatment
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* Procedure: percutaneous disc decompression with coblation nucleoplasty
* Procedure: Manual Therapy (SNAGs plus PJMs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of cervical vertigo upon characteristic symptoms of dizziness associated with neck stiffness and/or neck pain, which is related to movement or position of cervical spine; Subjects with obvious disc degeneration verified to exist at MRI; All the patients had recurring symptom of dizziness over three months and conservative treatment applied for at least three weeks and failed; Male or female aged between 18 and 80; Subjects' consent to participate and had signed the informed consent. Exclusion Criteria: Other causes of vertigo, including those arising from disturbances of the ear, nose, and throat (ENT); benign positional paroxysmal vertigo (BPPV); central nervous system (CNS); and cardiovascular system; Predominant radiculopathy cervical, cervical myelopathy or cervical stenosis; Inflammatory arthritis, neoplastic diseases, infection, trauma; History of previous cervical surgeries or cervical spine surgery during the follow-up period;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a prospective, one-center, controlled clinical study with random assignment to PDCN or manual therapy group to explore their effectiveness and safety for the treatment of cervicogenic dizziness. Participants will be randomized and allocated to either PDCN group or manual therapy group with 1:1 ratio and with 35 patients in each group.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: percutaneous disc decompression with coblation nucleoplasty<br>PDCN will be performed in patients who are allocated to this group by using the COBLATION Perc-DC SpineWand surgical device (ArthroCare System 2000, ArthroCare corporation, Heredia, Costa Rica, USA) | Procedure: percutaneous disc decompression with coblation nucleoplasty<br>* PDCN was performed using the COBLATION Perc-DC SpineWand surgical device (ArthroCare System 2000, ArthroCare corporation, Heredia, Costa Rica, USA) under local anesthesia. The introducer cannula was then pierced into the target intervertebral disc through an anterior lateral approach. The tip of the cannula stylet was aimed for the center of the nucleus in both the coronal and sagittal planes. The stylet was withdrawn from the introducer cannula and replaced with the Perc-DC SpineWand. The wand was advanced until its tip extended approximately 5 mm beyond the tip of the cannula. A short initial coagulation was performed upon wand insertion to ensure correct placement, if stimulation or movement was detected, the wand was repositioned. As the wand was drawn back out through the disc, ablation energy was set to level three and three ablation cycles of 5-12soconds each were performed, rotating the wand tip 180 degree each time to form three consecutive pockets within the disc.<br>* Other names: PDCN;|
| Active Comparator: Manual Therapy<br>Participants who are allocated to this group will undergo manual therapy treatments containing two kinds: sustained natural apophyseal glides (SNAGs) plus passive joint mobilisations (PJMs) | Procedure: Manual Therapy (SNAGs plus PJMs)<br>* (1) sustained natural apophyseal glides (SNAGs): Use the methods described in Mulligan BR. Manual therapy NAGS, SNAGS, MWMS etc. 5th ed. Wellington, New Zealand: Plane View Services; 2004. Three sessions per week and for a total of four to six weeks according to the patients' condition, they were asked to continue the self-SNAG once daily until the last follow-up, and recorded in a diary. (2) passive joint mobilisations (PJMs): Use the methods described in Maitland G. Vertebral manipulation. 6th ed. Oxford: Butterworth Heinemann; 2001. For three repetitions weekly and for a total of four to six weeks according to the patients' condition, then once a day were commenced as a home exercise to be continued until the last follow-up, and recorded in a diary.<br>* Other names: SNAGs together with PJMs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of baseline in Dizziness Intensity | Self-reported dizziness on a 100mm visual analogue scale (VAS) | Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness frequency (rated between o (none) and 5 (>once/day)) | Self-reported dizziness on a scale of 0-10 | Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 
| Change in Dizziness Handicap Index (DHI) Score | Self-reported measure evaluating perceived handicap secondary to dizziness, the DHI has 25 items with 3 response levels, sub-grouped into three domains: functional, emotional, and physical | Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 
| Change in Numeric Pain Rating Scale Score-Neck pain | Self-report score for headache on a scale of 0-10 | Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 
| Change in SF-36 Health Scale Score | Self-report score for assessing both of physical functioning and bodily pain on a scale of 12 items | Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 
| Clinical efficacy assessed by 10 point rating scale | 0=no benefit, 1=minimal benefit, 2=some benefit, 3=a lot of benefit, 4=great benefit, 5=maximal benefit | 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 
| Clinical efficacy evaluated by modified MacNab evaluation criteria | excellent (A)=dizziness and associated symptoms disappeared completely, resumed normal work and life; good (B)= improved significantly, could do former work; acceptable (C)=somewhat improved, could only undertake light work; poor (D)=not improved significantly, further treatment was required. Fitness rate=A+B; Effective rate=A+B+C | 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 
| Surgical complications | discitis, neurological complications, vascular injuries, dural Injury, CSF Leakage, recrudescence, and other severe adverse effects | during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention | 
| Image findings evaluated by Magnetic Resonance Imaging | changes of intervertebral disc signal and herniation | Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 
| Changes of intervertebral disc height assessed by X ray | height of anterior, middle and posterior portion of the targeted disc (disc with intervention) | Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 
| Changes of cobb angle assessed by X ray | draw a line either parallel to the inferior endplate of C-2 or extending from the anterior tubercle of C-1 to the posterior margin of the spinous process, and another line parallel to the inferior endplate of C-7. Perpendicular lines are then drawn from each of the 2 lines noted above, and the angle subtended between the crossing of the perpendicular lines is the cervical curvature angle | Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical vertigo, percutaneous disc decompression with coblation nucleoplasty, manual therapy, clinical efficacy, randomized controlled trial