PDCN for Treatment of Cervical Vertigo

Cervical Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03485768
• Other study ID #: PDCN-CV
• Status: Recruiting
• Phase: N/A
• First received: February 25, 2018
• Last updated: March 24, 2018
• Start date: January 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2018
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Shangfu Li, Ph.D
• Phone: +8613580583602
• Email: lishangfu2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 In the retrospective observational study (unpublished data), the investigators found that PDCN was effective for reducing cervicogenic dizziness, a disabling and persistent problem, in the long term.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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Cervical Vertigo
• Dizziness
• Vertigo

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the Third Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

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. Review. — View 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. Epub 2006 Jan 24. — View Citation

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. — View Citation

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. — View Citation

Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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