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Whiplash Associated DisorderNCT04622020

Cervical Plexus Block (CPB) in Whiplash Associated Disorder (WAD)

An observational study of Whiplash Associated Disorder, run by University Hospitals, Leicester at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Whiplash Associated Disorder
What is being tested?
Cervical Plexus Block with Local Anaesthesia and Cervical Plexus Block with Depot Steroids
Type of treatment
Surgery or procedure
How many people
50 participants
Where
1 siteUnited Kingdom
Study dates
26 Jun 2020to 20 Aug 2022
Phase
Observational
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: This study is based on a cohort of adult patients present with chronic neck pain arising from whiplash injury Chronic Neck Pain is defined as persistent neck pain that lasts for more than three months.

Who may be able to join

  • All patients aged over 18 years and under 90 years willing to consent
  • History of whiplash injury
  • Chronic neck pain for above 3 months
  • Moderate to severe pain in the neck: Baseline NRS >4 (worst pain the last 24 hours)

Who cannot join

  • Lack of consent, including from those patients who lack mental capacity to give informed consent.
  • Past History of chronic neck pain that was present before suffering a whiplash injury
  • Patients with known history of drug allergy to depomedrone
  • Patients with infection at injection site at on day of treatment
  • Patients aged under 18 years or over 90 years
  • Unwilling to provide consent

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University Hospitals of Leicester NHS Trust

    Leicester

Other trials in United Kingdom

About this study

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

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.

Read more

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.

Read the 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 - 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

Being tested
Cervical Plexus Block with Local Anaesthesia, Cervical Plexus Block with Depot Steroids
Keywords
Cervical Plexus Block, Whiplash injury, WAD
Medical subject headings
Whiplash Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cervical Plexus Block with Local AnaesthesiaProcedure or surgery

    Ultrasound guided intermediate cervical plexus block

  • Cervical Plexus Block with Depot SteroidsProcedure or surgery

    Ultrasound guided intermediate cervical plexus block

Study groups in NCT04622020
Study groupRoleWhat they receive
Adult patients with chronic neck pain (> 3 months) following whiplash injuryCervical plexus block with local anaesthesia followed by Cervical Plexus block with depot steroids
Receives: Procedure: Cervical Plexus Block with Local Anaesthesia; Procedure: Cervical Plexus Block with Depot Steroids

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary outcome will be Pain at its Worst in the last 24 hours at the baseline and 3 months following the interventional treatment

    Effective outcome: A two-point change in the Numerical Rating Scale (Pain at its worst in the last 24 hours) at three months when compared to the baseline. The Pain at its worst in 24 hours will be measured on the Brief Pain Inventory-short form (BPI-SF) question number 3 on Brief Pain Inventory -short form questionnaire. The expected change is a

    Measured: 3 months

Secondary outcomes (3)
  1. Treatment Failure rate: absence of sustained benefit at three month follow up

    No reduction in NRS 'Pain at its worst in the last 24 hours' at three months when compared to the baseline NRS

    Measured: 3 months

  2. Pain at its Worst in the last 24 hours at the baseline and 6 months

    Change in the Pain at its worst score at 6 months when compared to the baseline

    Measured: 6 months

  3. Change in Neck Disability Index (NDI) at 3 and 6 months when compared to baseline

    Change in neck disability index at three and 6 months when compared to the baseline scoree that is measured on the NDI questionnaire

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2020
  2. Study start26 Jun 2020
  3. Primary completion20 Aug 2022
  4. Study completion20 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04622020
Sponsor's protocol ID
EDGE 129250
Status last verified
May 2022
First submitted
1 Nov 2020
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Whiplash Associated Disorder, run by University Hospitals, Leicester at 1 site in United Kingdom.

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 4 inclusion and 6 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: finished, as of the sponsor's last update on 29 Nov 2023. 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 United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary outcome will be Pain at its Worst in the last 24 hours at the baseline and 3 months following the interventional treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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