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

NCT04622020 | Completed

• 1 other identifier: EDGE 129250
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Whiplash Associated Disorder

Keywords

Cervical Plexus Block; Whiplash injury; WAD

Outcome Measures

Primary Outcomes (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

  3 months

Secondary Outcomes (3)

• Treatment Failure rate: absence of sustained benefit at three month follow up

  3 months

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

  6 months

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

  6 months

Study Arms (1)

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

Procedure: Cervical Plexus Block with Local Anaesthesia; Procedure: Cervical Plexus Block with Depot Steroids

Interventions

Cervical Plexus Block with Local Anaesthesia PROCEDURE

Ultrasound guided intermediate cervical plexus block

Adult patients with chronic neck pain (> 3 months) following whiplash injury

Cervical Plexus Block with Depot Steroids PROCEDURE

Ultrasound guided intermediate cervical plexus block

Adult patients with chronic neck pain (> 3 months) following whiplash injury

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Whiplash Injuries

Interventions

Cervical Plexus Block; Anesthesia, Local

Condition Hierarchy (Ancestors)

Neck Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Nerve Block; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• G Niraj, MD

  University Hospitals, Leicester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 9, 2020
• Study Start: June 26, 2020
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: November 29, 2023

Record last verified: 2022-05

Locations

GB (1)