Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04622020
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2020-11-01
Brief Title:
Cervical Plexus Block CPB in Whiplash Associated Disorder WAD
Sponsor:
University Hospitals Leicester
Organization:
University Hospitals Leicester
Study Overview
Official Title:
Effectiveness of Ultrasound Guided Intermediate Cervical Plexus Block iCPB in Patients With Refractory Chronic Neck Pain From Whiplash Associated Disorder WAD an Observational Study
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Whiplash is the most common injury associated with motor vehicle accidents and a major cause of disability and litigation An acute whiplash injury follows sudden or excessive hyperextension hyper flexion or rotation of the neck affecting the soft tissues It typically results from rear-end or side-impact motor vehicle collisions Patients commonly present with pain and stiffness in the neck headache and upper backache Chronic whiplash syndrome is characterized by symptoms of neck pain that persist for more than 3 months 1 2 With over half a million people making whiplash injury claims per annum in the UK it has a major impact on the healthcare and legal systems and also the economy Over 40 of patients with whiplash injury report chronic neck pain and this is often refractory to conservative management pain relief medications physiotherapy Current treatment involves burning the small nerves that supply the joints facet joints in the neck Although they provide pain relief that can last 6-9 months the nerves re-grow and the treatment has to be repeated This treatment is a complex procedure that requires extensive training and has the potential to cause serious harm There is new evidence to show that the pain in whiplash injury could be due to an impaired function of the neck muscles arising from whiplash trauma Current treatment for this condition is injection of numbing medicine or steroids directly into the muscle Although this treatment is safer than burning the facet nerves it provides short-term relief
The investigators have shown that a novel treatment targeting the nerves that supply the muscles in the neck can provide durable relief in patients with chronic neck pain The medication is injected into a specific area plane in the neck of the patient and is called cervical plexus block CPB The investigators currently offer CBP treatment as a standard treatment in the management of patients with chronic neck pain arising from whiplash injury There are two types of CPB CPB with numbing medicine CPB-LA and CPB with steroid
Aim of the study is to evaluate the effectiveness of two types of Cervical Plexus Block CPB treatment in reducing pain at three months in patients with refractory chronic neck pain from whiplash injury
Methods The proposed study is a prospective observational pilot study that will be conducted at Leicester General Hospital over 36 months Potential participants will be given an information sheet by the clinical team when they are seen in the outpatient clinic The participants will have 24 hours to read the information sheet Thereafter the research team will approach the potential participant to obtain informed consent After providing written consent adult patients with chronic neck pain from whiplash injury will receive ultrasound guided CPB-LA in the theatre If treatment provides 30 relief at 3 months they will be re-assessed at six months and CPB-LAi will be repeated as per waiting list If at 3 months the pain returns to the baseline CPB with steroid will be performed If CPB with steroid does not provide any benefit the participants will receive a rescue treatment trigger point injection within three months Participants will be asked to complete questionnaires on pain scores and mood Participation in the study will end at 9 months following the first CPB treatment on completion of relevant questionnaires
The investigators have shown that a novel treatment targeting the nerves that supply the muscles in the neck can provide durable relief in patients with chronic neck pain The medication is injected into a specific area plane in the neck of the patient and is called cervical plexus block CPB The investigators currently offer CBP treatment as a standard treatment in the management of patients with chronic neck pain arising from whiplash injury There are two types of CPB CPB with numbing medicine CPB-LA and CPB with steroid
Aim of the study is to evaluate the effectiveness of two types of Cervical Plexus Block CPB treatment in reducing pain at three months in patients with refractory chronic neck pain from whiplash injury
Methods The proposed study is a prospective observational pilot study that will be conducted at Leicester General Hospital over 36 months Potential participants will be given an information sheet by the clinical team when they are seen in the outpatient clinic The participants will have 24 hours to read the information sheet Thereafter the research team will approach the potential participant to obtain informed consent After providing written consent adult patients with chronic neck pain from whiplash injury will receive ultrasound guided CPB-LA in the theatre If treatment provides 30 relief at 3 months they will be re-assessed at six months and CPB-LAi will be repeated as per waiting list If at 3 months the pain returns to the baseline CPB with steroid will be performed If CPB with steroid does not provide any benefit the participants will receive a rescue treatment trigger point injection within three months Participants will be asked to complete questionnaires on pain scores and mood Participation in the study will end at 9 months following the first CPB treatment on completion of relevant questionnaires
Detailed Description:
Whiplash is the most common injury associated with motor vehicle accidents and a major cause of disability and litigation An acute whiplash injury follows sudden or excessive hyperextension hyper flexion or rotation of the neck affecting the soft tissues It typically results from rear-end or side-impact motor vehicle collisions Patients commonly present with pain and stiffness in the neck headache and upper backache with or without paraesthesia of the upper limbs Chronic whiplash syndrome is characterized by symptoms that persist for more than 3 months With over half a million people making whiplash injury claims per annum in the UK it has a major impact on the healthcare and legal systems and also the economy In 1995 whiplash-associated disorder WAD was defined by the Quebec task force as Whiplash is an acceleration-deceleration mechanism of energy transfer to the neck The incidence of WAD is very variable averaging to about 9 per 1000 people in the UK the highest in Europe
Around 40 of patients suffer from symptoms of WAD beyond 3 months chronic whiplash and 2 - 45 of patients are left permanently disabled
There is evidence that neck pain in WAD could arise from either cervical facet joint or due to impaired function of neck muscles Cervicothoracic Myofascial Pain Syndrome CTMPS or both The investigators have recently reported on ultrasound guided cervical plexus block with depot steroids in the management of refractory cervicothoracic myofascial pain This intervention involves a single injection that targets a number of muscles that are commonly involved in causing chronic WAD The treatment has a definite end point that helps to standardize the intervention with a good safety profile
The present study is an observational study on the effectiveness of two types of cervical plexus block CPB-Local Anaesthesia and CPB-Steroids treatment as a part of standard care in providing durable analgesia The objective is to collect data to inform the design a larger multicentre study
Around 40 of patients suffer from symptoms of WAD beyond 3 months chronic whiplash and 2 - 45 of patients are left permanently disabled
There is evidence that neck pain in WAD could arise from either cervical facet joint or due to impaired function of neck muscles Cervicothoracic Myofascial Pain Syndrome CTMPS or both The investigators have recently reported on ultrasound guided cervical plexus block with depot steroids in the management of refractory cervicothoracic myofascial pain This intervention involves a single injection that targets a number of muscles that are commonly involved in causing chronic WAD The treatment has a definite end point that helps to standardize the intervention with a good safety profile
The present study is an observational study on the effectiveness of two types of cervical plexus block CPB-Local Anaesthesia and CPB-Steroids treatment as a part of standard care in providing durable analgesia The objective is to collect data to inform the design a larger multicentre study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None