PDCN for Treatment of Cervical Vertigo

NCT03485768 | Unknown DMC

• 1 other identifier: PDCN-CV
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Vertigo

Keywords

cervical vertigo; percutaneous disc decompression with coblation nucleoplasty; manual therapy; clinical efficacy; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Dizziness frequency (rated between o (none) and 5 (>once/day))

  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

  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

  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

  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

  1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment

Study Arms (2)

percutaneous disc decompression with coblation nucleoplasty

EXPERIMENTAL

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

Manual Therapy

ACTIVE COMPARATOR

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)

Interventions

percutaneous disc decompression with coblation nucleoplasty PROCEDURE

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.

Also known as: PDCN

percutaneous disc decompression with coblation nucleoplasty

Manual Therapy (SNAGs plus PJMs) PROCEDURE

(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.

Also known as: SNAGs together with PJMs

Manual Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

the Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 27638063 BACKGROUND

• 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.

  PMID: 13279136 BACKGROUND

• 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.

  PMID: 12030574 BACKGROUND

• 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.

  PMID: 16432749 BACKGROUND

• 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.

  PMID: 18628694 BACKGROUND

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

  PMID: 26218949 BACKGROUND

• 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.

  PMID: 19902277 BACKGROUND

• 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.

  PMID: 17278033 BACKGROUND

• 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.

  PMID: 20201654 BACKGROUND

• 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.

  PMID: 26851686 BACKGROUND

• 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.

  PMID: 24658486 BACKGROUND

• 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.

  PMID: 25220110 BACKGROUND

MeSH Terms

Interventions

Musculoskeletal Manipulations

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Limin Rong, Ph.D

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Central Study Contacts

Shangfu Li, Ph.D

CONTACT

+8613580583602; lishangfu2013@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 25, 2018
• First Posted: April 2, 2018
• Study Start: January 1, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: April 2, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)