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PDCN for Treatment of Cervical Vertigo

Primary Purpose

Cervical Vertigo

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
percutaneous disc decompression with coblation nucleoplasty
Manual Therapy (SNAGs plus PJMs)
Sponsored by
Third Affiliated Hospital, Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Vertigo focused on measuring cervical vertigo, percutaneous disc decompression with coblation nucleoplasty, manual therapy, clinical efficacy, randomized controlled trial

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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;

Sites / Locations

  • the Third Affiliated Hospital of Sun Yat-Sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

percutaneous disc decompression with coblation nucleoplasty

Manual Therapy

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

Change of baseline in Dizziness Intensity
Self-reported dizziness on a 100mm visual analogue scale (VAS)

Secondary Outcome Measures

Dizziness frequency (rated between o (none) and 5 (>once/day))
Self-reported dizziness on a scale of 0-10
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 in Numeric Pain Rating Scale Score-Neck pain
Self-report score for headache on a scale of 0-10
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
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
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
Surgical complications
discitis, neurological complications, vascular injuries, dural Injury, CSF Leakage, recrudescence, and other severe adverse effects
Image findings evaluated by Magnetic Resonance Imaging
changes of intervertebral disc signal and herniation
Changes of intervertebral disc height assessed by X ray
height of anterior, middle and posterior portion of the targeted disc (disc with intervention)
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

Full Information

First Posted
February 25, 2018
Last Updated
March 24, 2018
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03485768
Brief Title
PDCN for Treatment of Cervical Vertigo
Official Title
Therapeutic Effects and Safety of Percutaneous Disc Decompression With Coblation Nucleoplasty in Cervical Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 30, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Vertigo
Keywords
cervical vertigo, percutaneous disc decompression with coblation nucleoplasty, manual therapy, clinical efficacy, randomized controlled trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
percutaneous disc decompression with coblation nucleoplasty
Arm Type
Experimental
Arm Description
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)
Arm Title
Manual Therapy
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
percutaneous disc decompression with coblation nucleoplasty
Other Intervention Name(s)
PDCN
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Manual Therapy (SNAGs plus PJMs)
Other Intervention Name(s)
SNAGs together with PJMs
Intervention Description
(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.
Primary Outcome Measure Information:
Title
Change of baseline in Dizziness Intensity
Description
Self-reported dizziness on a 100mm visual analogue scale (VAS)
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
Secondary Outcome Measure Information:
Title
Dizziness frequency (rated between o (none) and 5 (>once/day))
Description
Self-reported dizziness on a scale of 0-10
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
Title
Change in Dizziness Handicap Index (DHI) Score
Description
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
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
Title
Change in Numeric Pain Rating Scale Score-Neck pain
Description
Self-report score for headache on a scale of 0-10
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
Title
Change in SF-36 Health Scale Score
Description
Self-report score for assessing both of physical functioning and bodily pain on a scale of 12 items
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
Title
Clinical efficacy assessed by 10 point rating scale
Description
0=no benefit, 1=minimal benefit, 2=some benefit, 3=a lot of benefit, 4=great benefit, 5=maximal benefit
Time Frame
1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Title
Clinical efficacy evaluated by modified MacNab evaluation criteria
Description
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
Time Frame
1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Title
Surgical complications
Description
discitis, neurological complications, vascular injuries, dural Injury, CSF Leakage, recrudescence, and other severe adverse effects
Time Frame
during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention
Title
Image findings evaluated by Magnetic Resonance Imaging
Description
changes of intervertebral disc signal and herniation
Time Frame
Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Title
Changes of intervertebral disc height assessed by X ray
Description
height of anterior, middle and posterior portion of the targeted disc (disc with intervention)
Time Frame
Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Title
Changes of cobb angle assessed by X ray
Description
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
Time Frame
Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shangfu Li, Ph.D
Phone
+8613580583602
Email
lishangfu2013@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limin Rong, Ph.D
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
the Third Affiliated Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Limin Rong, M.D.
Phone
862085252900
Email
ronglimin@21cn.com
First Name & Middle Initial & Last Name & Degree
Shangfu Li, M.D.
Phone
8613580583602
Email
lishangfu2013@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27638063
Citation
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Results Reference
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PubMed Identifier
13279136
Citation
RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. doi: 10.1016/s0140-6736(55)93159-7. No abstract available.
Results Reference
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PubMed Identifier
12030574
Citation
Wenngren BI, Pettersson K, Lowenhielm G, Hildingsson C. Eye motility and auditory brainstem response dysfunction after whiplash injury. Acta Otolaryngol. 2002 Apr;122(3):276-83. doi: 10.1080/000164802753648150.
Results Reference
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PubMed Identifier
16432749
Citation
Endo K, Ichimaru K, Komagata M, Yamamoto K. Cervical vertigo and dizziness after whiplash injury. Eur Spine J. 2006 Jun;15(6):886-90. doi: 10.1007/s00586-005-0970-y. Epub 2006 Jan 24.
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PubMed Identifier
18628694
Citation
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PubMed Identifier
26218949
Citation
Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
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PubMed Identifier
19902277
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Cesaroni A, Nardi PV. Plasma disc decompression for contained cervical disc herniation: a randomized, controlled trial. Eur Spine J. 2010 Mar;19(3):477-86. doi: 10.1007/s00586-009-1189-0. Epub 2009 Nov 10.
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PDCN for Treatment of Cervical Vertigo

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