Cervical VertigoNCT03485768
PDCN for Treatment of Cervical Vertigo
A study testing percutaneous disc decompression with coblation nucleoplasty and Manual Therapy (SNAGs plus PJMs) in people with Cervical Vertigo, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Vertigo
- What is being tested?
- percutaneous disc decompression with coblation nucleoplasty and Manual Therapy (SNAGs plus PJMs)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Limin Rong, M.D., 862085252900, ronglimin@21cn.com
Shangfu Li, M.D., 8613580583602, lishangfu2013@163.com
About this study
Official title: Therapeutic Effects and Safety of Percutaneous Disc Decompression With Coblation Nucleoplasty in Cervical Vertigo
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.
Read the 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.
- Conditions
- Cervical Vertigo
- Being tested
- percutaneous disc decompression with coblation nucleoplasty, Manual Therapy (SNAGs plus PJMs)
- Keywords
- cervical vertigo, percutaneous disc decompression with coblation nucleoplasty, manual therapy, clinical efficacy, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous disc decompression with coblation nucleoplastyProcedure or surgery
Also called PDCN
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)Procedure or surgery
Also called SNAGs together with 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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Procedure: Manual Therapy (SNAGs plus PJMs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline in Dizziness Intensity
Self-reported dizziness on a 100mm visual analogue scale (VAS)
Measured: 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))
Self-reported dizziness on a scale of 0-10
Measured: 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
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
Measured: 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
Self-report score for headache on a scale of 0-10
Measured: 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
Self-report score for assessing both of physical functioning and bodily pain on a scale of 12 items
Measured: 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
0=no benefit, 1=minimal benefit, 2=some benefit, 3=a lot of benefit, 4=great benefit, 5=maximal benefit
Measured: 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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
Measured: 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Surgical complications
discitis, neurological complications, vascular injuries, dural Injury, CSF Leakage, recrudescence, and other severe adverse effects
Measured: during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention
Image findings evaluated by Magnetic Resonance Imaging
changes of intervertebral disc signal and herniation
Measured: 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 height assessed by X ray
height of anterior, middle and posterior portion of the targeted disc (disc with intervention)
Measured: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
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
Measured: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Jan 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cervical VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Limin Rong, Ph.D, Study director, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485768
- Sponsor's protocol ID
- PDCN-CV
- Status last verified
- Mar 2018
- First submitted
- 25 Feb 2018
- Last updated
- 2 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27638063RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. doi: 10.1016/s0140-6736(55)93159-7. No abstract available.
PubMed 13279136Wenngren 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.
PubMed 12030574Endo 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.
PubMed 16432749Endo 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.
PubMed 18628694Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
PubMed 26218949Cesaroni 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.
PubMed 19902277Masala 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.
PubMed 17278033Gerszten 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.
PubMed 20201654Nikoobakht 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.
PubMed 26851686Eichen 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.
PubMed 24658486Reid 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.
PubMed 25220110
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects and Safety of Percutaneous Disc Decompression With Coblation Nucleoplasty in Cervical Vertigo
- ClinicalTrials.gov ID
- NCT03485768
- Acronym / sponsor ID
- PDCN-CV
- Conditions
- Cervical Vertigo
- Keywords
- cervical vertigo, percutaneous disc decompression with coblation nucleoplasty, manual therapy, clinical efficacy, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| percutaneous disc decompression with coblation nucleoplasty | Experimental | Procedure: percutaneous disc decompression with coblation nucleoplastyPDCN 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) |
| Manual Therapy | Active comparator | Procedure: 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous disc decompression with coblation nucleoplastyAlso: PDCNPDCN 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. | Procedure or surgery | percutaneous disc decompression with coblation nucleoplasty |
| Manual Therapy (SNAGs plus PJMs)Also: SNAGs together with 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. | Procedure or surgery | Manual Therapy |
Primary outcome
Change of baseline in Dizziness Intensity
Time frame: 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)
10 secondary outcomes
Dizziness frequency (rated between o (none) and 5 (>once/day))
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Clinical efficacy evaluated by modified MacNab evaluation criteria
Time frame: 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Surgical complications
Time frame: during operation, up to 1 week and 1 month and 3 months and 6 months respectively after intervention
Image findings evaluated by Magnetic Resonance Imaging
Time frame: 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 height assessed by X ray
Time frame: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Changes of cobb angle assessed by X ray
Time frame: Change between Baseline and 1 week- 1 month- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2018.
- Background: PubMed 27638063Neuhauser HK. The epidemiology of dizziness and vertigo. Handb Clin Neurol. 2016;137:67-82. doi: 10.1016/B978-0-444-63437-5.00005-4.
- Background: PubMed 13279136RYAN GM, COPE S. Cervical vertigo. Lancet. 1955 Dec 31;269(6905):1355-8. doi: 10.1016/s0140-6736(55)93159-7. No abstract available.
- Background: PubMed 12030574Wenngren 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.
- Background: PubMed 16432749Endo 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.
- Background: PubMed 18628694Endo 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.
- Background: PubMed 26218949Li Y, Peng B. Pathogenesis, Diagnosis, and Treatment of Cervical Vertigo. Pain Physician. 2015 Jul-Aug;18(4):E583-95.
- Background: PubMed 19902277Cesaroni 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.
- Background: PubMed 17278033Masala 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.
- Background: PubMed 20201654Gerszten 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.
- Background: PubMed 26851686Nikoobakht 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.
- Background: PubMed 24658486Eichen 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.
- Background: PubMed 25220110Reid 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Limin Rong, Ph.D study director
Third Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous disc decompression with coblation nucleoplasty and Manual Therapy (SNAGs plus PJMs) in people with Cervical Vertigo, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shangfu Li, Ph.D (+8613580583602, lishangfu2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of baseline in Dizziness Intensity (time frame: Change between Baseline and 1 week- 1 month- 3 months- 6 months- 1 year- 2 years- 3 years- 5 years respectively after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03485768, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2018.