PDCN for Treatment of Cervical Vertigo
- Conditions
- Cervical Vertigo
- Interventions
- Procedure: Manual Therapy (SNAGs plus PJMs)Procedure: percutaneous disc decompression with coblation nucleoplasty
- Registration Number
- NCT03485768
- Lead Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- 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 In the retrospective observational study (unpublished data), the investigators found that PDCN was effective for reducing cervicogenic dizziness, a disabling and persistent problem, in the long term.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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manual Therapy Manual Therapy (SNAGs plus PJMs) 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) percutaneous disc decompression with coblation nucleoplasty 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)
- Primary Outcome Measures
Name Time Method Change of baseline in Dizziness Intensity Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment Self-reported dizziness on a 100mm visual analogue scale (VAS)
- Secondary Outcome Measures
Name Time Method Clinical efficacy evaluated by modified MacNab evaluation criteria 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment 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
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 Self-report score for assessing both of physical functioning and bodily pain on a scale of 12 items
Surgical complications during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention discitis, neurological complications, vascular injuries, dural Injury, CSF Leakage, recrudescence, and other severe adverse effects
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 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 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 Self-report score for headache on a scale of 0-10
Changes of cobb angle assessed by X ray Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment 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
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 Self-reported dizziness on a scale of 0-10
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 0=no benefit, 1=minimal benefit, 2=some benefit, 3=a lot of benefit, 4=great benefit, 5=maximal benefit
Image findings evaluated by Magnetic Resonance Imaging Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment changes of intervertebral disc signal and herniation
Changes of intervertebral disc height assessed by X ray Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment height of anterior, middle and posterior portion of the targeted disc (disc with intervention)
Trial Locations
- Locations (1)
the Third Affiliated Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China