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.
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
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
- Conditions
- Whiplash Associated Disorder
- 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 group | Role | What they receive |
|---|---|---|
| Adult patients with chronic neck pain (> 3 months) following whiplash injury | Cervical 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.
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)
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
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
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.
- First posted9 Nov 2020
- Study start26 Jun 2020
- Primary completion20 Aug 2022
- Study completion20 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whiplash Associated DisorderStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- G Niraj, MD, Principal investigator, University Hospitals, Leicester
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04622020
- Acronym / sponsor ID
- EDGE 129250
- Conditions
- Whiplash Associated Disorder
- Keywords
- Cervical Plexus Block, Whiplash injury, WAD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Aug 2022 (actual)
- First posted
- 9 Nov 2020 (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.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with chronic neck pain (> 3 months) following whiplash injury | – | Procedure: Cervical Plexus Block with Local Anaesthesia, Procedure: Cervical Plexus Block with Depot SteroidsCervical plexus block with local anaesthesia followed by Cervical Plexus block with depot steroids |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Cervical Plexus Block with Local AnaesthesiaUltrasound guided intermediate cervical plexus block | Procedure or surgery | Adult patients with chronic neck pain (> 3 months) following whiplash injury |
| Cervical Plexus Block with Depot SteroidsUltrasound guided intermediate cervical plexus block | Procedure or surgery | Adult patients with chronic neck pain (> 3 months) following whiplash injury |
Primary outcome
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
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
3 secondary outcomes
Treatment Failure rate: absence of sustained benefit at three month follow up
Time frame: 3 months
Pain at its Worst in the last 24 hours at the baseline and 6 months
Time frame: 6 months
Change in Neck Disability Index (NDI) at 3 and 6 months when compared to baseline
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
Related trials for Whiplash Associated Disorder
Active, not recruiting
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders.
Whiplash-associated Disorders
Not yet recruiting
StressModex for Post-Traumatic Neck Pain
Post-Traumatic Neck Pain, Whiplash-associated Disorders
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
RecruitingObservational study
Assessment of the Alignment of the Atlas and Surrounding Tissues in Chronic Whiplash Associated Disorder
Chronic Whiplash Associated Disorder
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.
G Niraj, MD principal investigator
University Hospitals, Leicester
1 site in 1 country: see every site and its status.
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.