Whiplash-induced Thoracic Outlet Syndrome Treated With Botulinum Toxin.

Management of Functional Thoracic Outlet Syndrome (TOS - Whiplash) With IncobotulinumtoxinA Injections

Whiplash injuries following car accident are common, it has been reported to affect 83% of individuals injured in traffic collisions (Yadla S, 2007). The condition is caused by a rapid acceleration followed immediately by a rapid deceleration of the neck and head. The annual North American incidence rate is estimated to be 600 per 100,000 people (Holm LW, 2008). The condition is costly for society and disabling/painful for the patients. Depending on the collision type, the biomechanics of muscles will be affected differently and consequently the clinical presentation will vary. T-bone type of car collisions (when the front of one vehicle strikes the side of another) may induce thoracic outlet syndrome (TOS) following compression on the nerve and artery bundle by the scalene muscles (lateral stabilizers of the neck). An appropriate and detailed examination of the patient is necessary to identify the cause of the resulting pain and disability. Once a functional thoracic outlet syndrome is identified the proposal is to treat this with botulinum toxin.

Study Overview

• Status: Not yet recruiting
• Conditions: Whiplash Injuries; Thoracic Outlet Syndrome
• Intervention / Treatment: Drug: IncobotulinumtoxinA 100 UNT

Detailed Description

TOS symptoms will typical emerge within 24-48 hours following the accident. The duration will depend on the level of severity of the muscle damage. If the severity is a grade 1 (mild damage to individual muscle fibers), symptoms may last up to 3 weeks. If the severity is a grade 2 (more extensive damage with more muscle fibers involved/no complete rupture), symptoms may last up to 3 months. However, in many cases, due to muscle swelling and consequently compression of the nerve plexus, a persistent reflex spasm of muscle develops.

A potentially effective treatment strategy, in patients presenting TOS associated clinical symptoms in the proper distribution, is to relax the scalene muscles that surround the nerve plexus. Botulinum toxin, such as incobotulinumtoxinA (XEOMIN, Merz herapeutics), have been shown to be effective and safe in relaxing these muscles in conditions like spasticity, blepharospasm and cervical dystonia (Kanovský P, 2009; Benecke R, 2005; Roggenkämper P, 2005). It is hypothesised that a subtype of whiplash defined as functional TOS could be improved with incobotulinumtoxinA injections into the medial scalene muscle. IncobotulinumtoxinA when injected into the medial scalene is expected to induce muscle relaxation which leads to nerve plexus decompression. The effect is anticipated to last approximately 3 months, which is the duration of effect of botulinum toxins type A. A similar effect can be induced using a local anaesthetic, such xylocaine, since it has a similar mechanism of action, but his effect should be short lived.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: David B King, BSc, MD; Phone Number: 902 425 7344; Email: david.larkspur@gmail.com
• Study Contact Backup: Name: Debbie Cavicchi, BA; Phone Number: 902 425 7344; Email: dking@davidbking.ca

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3P 1M3
      • Private Office
      • Contact: David B King, BSc, MD; Phone Number: 902 425 7344; Email: david.larkspur@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Patient must have been diagnosed with a muscle strain to the lateral neck muscles following a car accident and there must be the following clinical signs of TOS: pain in the proper distribution, weakened grip, shoulder elevation on the appropriate side and numbness or tingling in the arm or fingers;

  • Patient must have no signs suggesting a radiculopathy that could account for similar symptoms;
  • Patient must have a PDQ >70, i.e. in the moderate to very severe disability range;
  • Patient must experience symptoms for longer than 3 months;
  • Patient must have had the accident leading to whiplash within the last 3 years;
  • Patient must be 18 years of age or older;
  • Patient must be eligible and agreeable to treatment with BoNT-A;
  • Patient must be toxin-naïve for the treatment of the cervical region, or have undergone a six months washout period;
  • Patient must be English speaking;
  • Patient must be able to provide informed consent.

Exclusion Criteria:

• • Patient unable or unwilling to complete the necessary assessment tasks;

  • Patient with hypersensitivity to botulinum neurotoxin type A or to any of the excipients, generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome), or infection or inflammation at the proposed injection site(s);
  • Patient who requires physiotherapy and/or massage therapy;
  • Patient for whom concomitant medications are not controlled at study start and/or may require change/adjustment during the study;
  • Patient who had surgery which may interfere with the study;
  • Women who are pregnant or nursing, or women in age of reproduction not using a contraceptive method;
  • Patient in active litigation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pain disability as assessed using the PDQ at Week 4.	PDQ before and after treatment. Pain Disability Questionnaire (Guides to the Evaluation of Permanent Impairment, Sixth Edition. 0= No pain related impairment 1-70= Mild pain related impairment 71-100=Moderate pain related impairment 101-130= Severe pain related impairment 131-150= Extreme pain related impairment	week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Elevation	Change from baseline in shoulder elevation as assessed by measurement on photograph (clavicular angle) at Weeks 4, 12 and 16;	week 4
Grip Strength	3. Change from baseline in grip strength as assessed using a dynamometer at Weeks 4, 12 and 16;	Week 4
Pinch Test	4. Change from baseline in fine motor test (pinch test) at Weeks 4, 12 and 16;	WFeek 4

Collaborators and Investigators

• Sponsor: King, David, MD
• Collaborators: MERZ PHARMA

Study record dates

Study Major Dates

• Study Start (Anticipated): October 15, 2022
• Primary Completion (Anticipated): April 15, 2023
• Study Completion (Anticipated): June 15, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 13, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Neck Injuries; Syndrome; Whiplash Injuries; Thoracic Outlet Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: EMSI-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No