PDCN for Treatment of Cervical Vertigo

Sun Yat-sen University

Status: Unknown

Conditions: Cervical Vertigo

Treatments: Procedure: Manual Therapy (SNAGs plus PJMs); Procedure: percutaneous disc decompression with coblation nucleoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT03485768

PDCN-CV

Details and patient eligibility

About

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.

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 In the retrospective observational study (unpublished data), the investigators found that PDCN was effective for reducing cervicogenic dizziness, a disabling and persistent problem, in the long term.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

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

percutaneous disc decompression with coblation nucleoplasty

Experimental group

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)

Treatment:

Procedure: percutaneous disc decompression with coblation nucleoplasty

Manual Therapy

Active Comparator group

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)

Treatment:

Procedure: Manual Therapy (SNAGs plus PJMs)