Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04622020 |
| Other study ID # |
EDGE 129250 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 26, 2020 |
| Est. completion date |
August 20, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
University Hospitals, Leicester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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 -
4.5% 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
