- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03485768
PDCN for Treatment of Cervical Vertigo
March 24, 2018 updated by: Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
Therapeutic Effects and Safety of Percutaneous Disc Decompression With Coblation Nucleoplasty in Cervical Vertigo
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.
Study Overview
Status
Unknown
Conditions
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In the retrospective observational study (unpublished data), the investigators found that PDCN was effective for reducing cervicogenic dizziness, a disabling and persistent problem, in the long term.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 Type
Interventional
Enrollment (Anticipated)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Shangfu Li, Ph.D
- Phone Number: +8613580583602
- Email: lishangfu2013@163.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510630
- Recruiting
- The Third Affiliated Hospital of Sun Yat-sen University
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Contact:
- Shangfu Li, M.D.
- Phone Number: 8613580583602
- Email: lishangfu2013@163.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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)
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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 Names:
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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)
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(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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Self-reported dizziness on a 100mm visual analogue scale (VAS)
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Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Self-reported dizziness on a scale of 0-10
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Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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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
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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
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Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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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
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Self-report score for headache on a scale of 0-10
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Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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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
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Self-report score for assessing both of physical functioning and bodily pain on a scale of 12 items
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Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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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
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0=no benefit, 1=minimal benefit, 2=some benefit, 3=a lot of benefit, 4=great benefit, 5=maximal benefit
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1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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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
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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
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1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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Surgical complications
Time Frame: during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention
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discitis, neurological complications, vascular injuries, dural Injury, CSF Leakage, recrudescence, and other severe adverse effects
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during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention
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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
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changes of intervertebral disc signal and herniation
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Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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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
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height of anterior, middle and posterior portion of the targeted disc (disc with intervention)
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Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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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
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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
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Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Limin Rong, Ph.D, Third Affiliated Hospital, Sun Yat-Sen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Reid SA, Callister R, Snodgrass SJ, Katekar MG, Rivett DA. Manual therapy for cervicogenic dizziness: Long-term outcomes of a randomised trial. Man Ther. 2015 Feb;20(1):148-56. doi: 10.1016/j.math.2014.08.003. Epub 2014 Aug 27.
- Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
- 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.
- Neuhauser HK. The epidemiology of dizziness and vertigo. Handb Clin Neurol. 2016;137:67-82. doi: 10.1016/B978-0-444-63437-5.00005-4.
- 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.
- 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.
- Endo K, Suzuki H, Yamamoto K. Consciously postural sway and cervical vertigo after whiplash injury. Spine (Phila Pa 1976). 2008 Jul 15;33(16):E539-42. doi: 10.1097/BRS.0b013e31817c55fe.
- 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.
- Masala S, Massari F, Fabiano S, Ursone A, Fiori R, Pastore F, Simonetti G. Nucleoplasty in the treatment of lumbar diskogenic back pain: one year follow-up. Cardiovasc Intervent Radiol. 2007 May-Jun;30(3):426-32. doi: 10.1007/s00270-006-0223-4.
- Gerszten PC, Smuck M, Rathmell JP, Simopoulos TT, Bhagia SM, Mocek CK, Crabtree T, Bloch DA; SPINE Study Group. Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: a prospective, randomized, controlled trial. J Neurosurg Spine. 2010 Apr;12(4):357-71. doi: 10.3171/2009.10.SPINE09208.
- Nikoobakht M, Yekanineajd MS, Pakpour AH, Gerszten PC, Kasch R. Plasma disc decompression compared to physiotherapy for symptomatic contained lumbar disc herniation: A prospective randomized controlled trial. Neurol Neurochir Pol. 2016;50(1):24-30. doi: 10.1016/j.pjnns.2015.11.001. Epub 2015 Nov 28.
- Eichen PM, Achilles N, Konig V, Mosges R, Hellmich M, Himpe B, Kirchner R. Nucleoplasty, a minimally invasive procedure for disc decompression: a systematic review and meta-analysis of published clinical studies. Pain Physician. 2014 Mar-Apr;17(2):E149-73.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
December 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
February 25, 2018
First Submitted That Met QC Criteria
March 24, 2018
First Posted (Actual)
April 2, 2018
Study Record Updates
Last Update Posted (Actual)
April 2, 2018
Last Update Submitted That Met QC Criteria
March 24, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PDCN-CV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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