Clinical trial NCT03485768: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Vertigo
Keywords: cervical vertigo
percutaneous disc decompression with coblation nucleoplasty
manual therapy
clinical efficacy
randomized controlled trial
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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 In the retrospective observational study (unpublished data), the investigators found that PDCN was effective for reducing cervicogenic dizziness, a disabling and persistent problem, in the long term.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

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;

Primary outcomes:
measure: Change of baseline in Dizziness Intensity
timeFrame: 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:
measure: Dizziness frequency (rated between o (none) and 5 (>once/day))
timeFrame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
measure: Change in Dizziness Handicap Index (DHI) Score
timeFrame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
measure: Change in Numeric Pain Rating Scale Score-Neck pain
timeFrame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
measure: Change in SF-36 Health Scale Score
timeFrame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
measure: Clinical efficacy assessed by 10 point rating scale
timeFrame: 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
measure: Clinical efficacy evaluated by modified MacNab evaluation criteria
timeFrame: 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
measure: Surgical complications
timeFrame: during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention
measure: Image findings evaluated by Magnetic Resonance Imaging
timeFrame: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
measure: Changes of intervertebral disc height assessed by X ray
timeFrame: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
measure: Changes of cobb angle assessed by X ray
timeFrame: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Third Affiliated Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Limin Rong, Ph.D
role: STUDY_DIRECTOR
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