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PDCN for Treatment of Cervical Vertigo

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ClinicalTrials.gov Identifier: NCT03485768
Recruitment Status : Unknown
Verified March 2018 by Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : April 2, 2018
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Vertigo Procedure: percutaneous disc decompression with coblation nucleoplasty Procedure: Manual Therapy (SNAGs plus PJMs) Not Applicable

Detailed Description:
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 In the retrospective observational study (unpublished data), the investigators found that PDCN was effective for reducing cervicogenic dizziness, a disabling and persistent problem, in the long term.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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Therapeutic Effects and Safety of Percutaneous Disc Decompression With Coblation Nucleoplasty in Cervical Vertigo
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: percutaneous disc decompression with coblation nucleoplasty
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
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.
Other Name: PDCN
Active Comparator: Manual Therapy
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)
(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.
Other Name: SNAGs together with PJMs


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


Secondary Outcome Measures :
  1. Dizziness frequency (rated between o (none) and 5 (>once/day)) [ Time Frame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment ]
    Self-reported dizziness on a scale of 0-10

  2. Change in Dizziness Handicap Index (DHI) Score [ Time Frame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment ]
    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

  3. Change in Numeric Pain Rating Scale Score-Neck pain [ Time Frame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment ]
    Self-report score for headache on a scale of 0-10

  4. Change in SF-36 Health Scale Score [ Time Frame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment ]
    Self-report score for assessing both of physical functioning and bodily pain on a scale of 12 items

  5. Clinical efficacy assessed by 10 point rating scale [ Time Frame: 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment ]
    0=no benefit, 1=minimal benefit, 2=some benefit, 3=a lot of benefit, 4=great benefit, 5=maximal benefit

  6. Clinical efficacy evaluated by modified MacNab evaluation criteria [ Time Frame: 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment ]
    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

  7. Surgical complications [ Time Frame: during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention ]
    discitis, neurological complications, vascular injuries, dural Injury, CSF Leakage, recrudescence, and other severe adverse effects

  8. Image findings evaluated by Magnetic Resonance Imaging [ Time Frame: 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 signal and herniation

  9. Changes of intervertebral disc height assessed by X ray [ Time Frame: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment ]
    height of anterior, middle and posterior portion of the targeted disc (disc with intervention)

  10. Changes of cobb angle assessed by X ray [ Time Frame: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485768


Contacts
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Contact: Shangfu Li, Ph.D +8613580583602 lishangfu2013@163.com

Locations
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China, Guangdong
the Third Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Limin Rong, M.D.    862085252900    ronglimin@21cn.com   
Contact: Shangfu Li, M.D.    8613580583602    lishangfu2013@163.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Director: Limin Rong, Ph.D Third Affiliated Hospital, Sun Yat-Sen University
More Information
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Publications:

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Responsible Party: Limin Rong, Professor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03485768    
Other Study ID Numbers: PDCN-CV
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University:
cervical vertigo
percutaneous disc decompression with coblation nucleoplasty
manual therapy
clinical efficacy
randomized controlled trial
Additional relevant MeSH terms:
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Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
 Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Sensation Disorders